Page 1 of 25

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Pharmaceutical Guidelines:

Guidelines for Quality Assurance

30 common ways to avoid making the most frequent GMP errors

Adverse reaction of pharmaceutical dosages forms
An overview of ISO 14644 clean room classification
Analytical method validation
Biocontamination control techniques for purified water sysem
Chemical Sanitization of RO Systems and Biofilm Removal
Clean Room System in Sterile Pharmaceutical
Clean Rooms And Controlled Areas (Sterile Area Classification)
Cleaning Validation Protocol for Pharmaceuticals
Cleaning Validation in Pharmaceuticals
Cleaning Validation of Pharmaceutical Equipments
Cleaning and Disinfection of a Newly Purified water system before Start Up
Clinical Trials
Concept of Revalidation in Pharmaceuticals
Corrective and Preventive actions (CAPA)
Deviation Control in Pharmaceuticals
Differece between water (moisture) content and loss on drying (LOD)
Difference among calibration, validation & qualification
FDAs New Process Validation Guidance
Facility Qualification in Pharmaceuticals
GMP Audit Check List- Equipment
GMP Audit Check List- Filling and Packaging
GMP Audit Check List- Personnel and Premises
GMP Audit Check List- Process Validation
GMP Audit Check List- Sanitation and Hygiene
GMP Audit Check List- Storage of Starting Materials
GMP Audit Check List- Weighing and Dispensing
GMP Audit Check List- water supply system
GMP Observations in Production
Good Documentation Practices (GDP) in Pharmaceuticals
Guide To Inspections of High Purity Water Systems
Guidelines for preparation of Site Master File (SMF)
Guidelines for the preparation of VMP (Validation Master Plan)
HEPA filters used in pharmaceuticals
HVAC system validation tests
Handling of Pharmaceutical Market Complaints
Handling of out of calibration instruments and equipment
High-Efficiency Particulate Air (HEPA) and its significance in sterile pharmaceutical preparations
Hold time study of cleaned equipments
List of Standard Operating Procedures (SOPs) in Quality Assurance
Media Fill Validation -SVP

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2013 All rights reserved to Pharmaceutical Guidelines and may not be reproduced on other websites. Designed by Pharmaceutical Guidelines
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 Page 2 of 25
Keep this document always with you, this will always help you to learn about pharmaceuticals. Ver.- 1.2
Media fill validation test in sterile pharmaceutical
Mix Up and Cross Contamination in Pharmaceutical Manuacturing
Non-sterile Process Validation in Pharmaceuticals
Passivation of Purified water system/ WFI system in pharmaceuticals
Pharmaceutical Bioavailability and Bioequivalence
Pharmaceutical product recall procedure
Prevention of Cross - contamination during Processing
Prevention of Cross- contamination by HVAC in Pharmaceuticals
Prevention of Cross- contamination in Pharmaceuticals
Procedure for Change Control in Pharmaceuticals
Procedure for garment change and entry and exit through first and primary change room
Procedure for in process checking during off-line and on line packing in pharmaceuticals
Procedure for line clearance before commencing any manufacturing operation
Procedure for preparation of APR (Annual Product Review)
Procedure for the qualification of vendors for the raw material and packaging materials
Product Recall Procedure in Pharmaceuticals
Prospective Validation
Protocol for hold time study of prepared control standard endotoxin (CSE)
Purified Water System
Purified Water System Validation
Purpose of Process Validation in Pharmaceuticals
Qualification of systems and equipments in pharmaceuticals
Requirements of Schedule L1 (Indian GLP) Good Laboratory Practice in Pharmaceutical
Rounding Off Values In GMP Documents in Pharmaceuticals
Rounding off figures of analytical results
SOP of SOP (SOP on SOP) in Pharmaceuticals
SOP on Standard Operating Procedure
Site Master File (SMF) for pharmaceuticals
Summary of ISO 14644 (ISO cleanliness classes)
Terminology & Definitions in Pharmaceuticals
Types of water used in pharmaceutical processes
Validation in pharmaceutical manufacturing
Validation of Supporting Processes in Pharmaceuticals
WHO Qualification List for Pharmaceutical Equipments
WHO SOP list for Pharma Microbiology
WHO SOP list for Pharma Production
WHO SOP list for Pharma Quality Assurance
WHO SOP list for Pharma Quality Control
WHO SOP list for Pharma Quality Control Cleaning
WHO SOP list for Pharma Quality Control Operations
WHO: Water for pharmaceutical use
What WHO says about cross-contamination?
What is HEPA filter? Its use in Pharma
What is change control ?
cGMP guidelines for pharmaceutical industries part-1

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 Page 3 of 25
Keep this document always with you, this will always help you to learn about pharmaceuticals. Ver.- 1.2
cGMP guidelines for pharmaceutical industries part-2
cGMP regulations for finished pharmaceuticals and medical devices

Guidelines for Quality Control

Analytical Balance Calibration

Analytical method validation
Appearance of Solution
Assay of Ascorbic acid
Assay of Calcium Carbonate
Assay of Calcium Citrate
Atomic Absorption Spectrometry
Atomic Emission Spectrometry
Bursting Strength Tester
Calibration of Brookfield viscometer in pharmaceuticals
Calibration of Disintegration Test Apparatus
Calibration of FT-IR Spectrophotometer
Calibration of Halogen moisture analyzer
Calibration of TOC (Total Organic Carbon)Analyser
Calibration of Total organic carbon Analyzer
Calibration of UV / Visible spectrophotometer
Calibration of Volumetric Glassware used in Pharmaceuticals
Calibration of automatic potentiometric titrator
Calibration of digital polarimeter
Calibration of eppendorf centrifuge apparatus
Calibration of glassware (class A and class B)
Calibration of hardness tester in pharmaceuticals
Calibration of melting point apparatus
Calibration of refractometer in pharmaceuticals
Calibration of vernier caliper
Cleaning of Glassware With Nitric Acid and Chromic Acid
Climatic zones for stability studies
Conductivity of Purified Water (Apparatus and Procedure) in Pharmaceutical
Congealing Range or Temperature
Contents (Weight or Volume Uniformity) of Packaged Dosage Forms
Determination and Acceptance limits of Uniformity of Content of Single-Dose Preparations
Determination of Acetyl Value
Determination of Acid Value
Determination of Assay of Nitrous Oxide
Determination of Assay of Oxygen
Determination of Assay of Steroids
Determination of Assay of Vitamin D
Determination of Boiling Range or Temperature and Distillation Range
Determination of Esters
Determination of Ethanol-Soluble Extractive

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2013 All rights reserved to Pharmaceutical Guidelines and may not be reproduced on other websites. Designed by Pharmaceutical Guidelines
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 Page 4 of 25
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Determination of Foreign Organic Matter
Determination of Freezing Point
Determination of Hydroxyl Value
Determination of Iodine Value
Determination of Loss on Ignition
Determination of Methoxyl
Determination of Nitrogen
Determination of Optical Rotation and Specific Optical Rotation
Determination of Peroxide Value
Determination of Refractive Index
Determination of Saponification Value
Determination of Solubility in Pharmaceuticals
Determination of Sulphur Dioxide
Determination of Total Organic Carbon in Purified Water
Determination of Total Solids
Determination of Unsaponifiable Matter
Determination of Viscosity by Using Ostwald-type, Suspended-level and Rotating Viscometer
Determination of Weight Per Millilitre and Relative Density
Determination of Zinc Content
Differece between water (moisture) content and loss on drying (LOD)
Difference among calibration, validation & qualification
Dimensions of Hard Gelatin Capsule Shells
Disintegration Test and Apparatus
Dissolution Test (DT) Apparatus Operating Procedure
Dissolution Test and Apparatus
Dissolution Testing apparatus calibration in pharmaceuticals
Flame Photometry (Apparatus and Method)
Fluorimetry
Friability Test Apparatus Calibration
Friability of Uncoated Tablets
GC Calibration
Good Documentation Practices (GDP) in Pharmaceuticals
Good Laboratories Practice (GLP) in Pharmaceuticals
Guideline for preparation of mobile phase required for HPLC
Guidelines For Receipt And Usage of Reference Standards and Qualification and Usage of
Working Standards
Guidelines for Pharmaceutical Stability Study
HPLC Caibration in Pharmaceuticals
HPLC Column Performance Evaluation and Column Care
Handling of out of calibration instruments and equipment
Handling, Cleaning & Storage of Cuvettes of Spectrophotometer
Havey Metals Testing
ICH Guidelines for Pharmaceuticals
Identification Test of Barbiturates
Identification of Environmental Flora

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2013 All rights reserved to Pharmaceutical Guidelines and may not be reproduced on other websites. Designed by Pharmaceutical Guidelines
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 Page 5 of 25
Keep this document always with you, this will always help you to learn about pharmaceuticals. Ver.- 1.2
Identification test of Phenothiazines
Indicator (Litmus Paper) and Test Papers
Investigation on sterility failure
Ionising Radiation Sterilisation
Karl fisher apparatus calibration in pharmaceuticals
Limit Test for Aluminium
Limit Test for Arsenic in Pharmaceuticals
Limit Test for Heavy Metals in Pharmaceuticals
Limit Test for Iron and Lead
Limit Test for Potassium and Sulphates
List of Current ICH Quality Guidelines for Stability
List of Standard Operating Procedures (SOPs) in Quality Control (QC)
Maintenance of Primary Standards in Pharmaceutical Industries
Melting Range or Temperature (Apparatus and Deternination)
Method for Nitrite Titration
Operating Procedure for Weighing Balances
Paper Chromatography (Apparatus and Peocedure)
Particle Size by Microscopy
Pharmaceutical Analytical Method Validation With Definitions
Pharmaceutical Bioavailability and Bioequivalence
Pharmaceuticals Limit tests
Potentiometric Titration
Powder Fineness (Types of Powder)
Preparation and Standardisation of Volumetric Solutions
Preparation and Standardization of 0.004 M Benzethonium Chloride
Preparation and Standardization of 0.1 M Ceric Ammonium Nitrate
Preparation and Standardization of 0.0005 M Dioctyl Sodium Sulphosuccinate
Preparation and Standardization of 0.001 M Sodium Dodecyl Sulphate
Preparation and Standardization of 0.0167 M Potassium Dichromate
Preparation and Standardization of 0.02 M Cupric Sulphate
Preparation and Standardization of 0.02 M Mercuric Nitrate
Preparation and Standardization of 0.02 M Potassium Permanganate
Preparation and Standardization of 0.05 M Magnesium Sulphate
Preparation and Standardization of 0.05 M Barium Chloride
Preparation and Standardization of 0.05 M Bromine
Preparation and Standardization of 0.05 M Iodine
Preparation and Standardization of 0.05 M Potassium Iodate
Preparation and Standardization of 0.1 M Ammonium Thiocyanate
Preparation and Standardization of 0.1 M Ceric Ammonium Sulphate
Preparation and Standardization of 0.1 M Disodium Edetate (EDTA)
Preparation and Standardization of 0.1 M Ethanolic Potassium Hydroxide
Preparation and Standardization of 0.1 M Ethanolic Sodium Hydroxide
Preparation and Standardization of 0.1 M Ferric Ammonium Sulphate
Preparation and Standardization of 0.1 M Ferrous Ammonium Sulphate
Preparation and Standardization of 0.1 M Hydrochloric acid (HCl)

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 Page 6 of 25
Keep this document always with you, this will always help you to learn about pharmaceuticals. Ver.- 1.2
Preparation and Standardization of 0.1 M Lead Nitrate
Preparation and Standardization of 0.1 M Lithium Methoxide
Preparation and Standardization of 0.1 M Perchloric acid
Preparation and Standardization of 0.1 M Potassium Hydroxide
Preparation and Standardization of 0.1 M Silver nitrate
Preparation and Standardization of 0.1 M Sodium Methoxide
Preparation and Standardization of 0.1 M Sodium Nitrite
Preparation and Standardization of 0.1 M Sodium Thiosulphate
Preparation and Standardization of 0.1 M Tetrabutylammonium Hydroxide
Preparation and Standardization of 0.1 M Titanium Trichloride
Preparation and Standardization of 0.1 M Zinc Chloride
Preparation and Standardization of 0.1 M Zinc Sulphate
Preparation and Standardization of 0.25 M Ethanolic Sulphuric Acid
Preparation and Standardization of 0.5 M Methanolic Hydrochloric Acid
Preparation and Standardization of 0.5 M Potassium Hydroxide in ethanol (60 per cent )
Preparation and Standardization of 0.5 M Sulphuric Acid
Preparation and Standardization of 1 M Nitric Acid
Preparation and Standardization of 1M Hydrochloric Acid
Preparation and Standardization of Volumeteric Solutions
Preparation of Buffer Solutions
Preparation of Indicator Solutions
Preparation of Standard Solutions
Primary Standards used in Pharmaceuticals
Principle and Calibration of Ultraviolet and Visible Absorption Spectrophotometry
Procedure for the qualification of vendors for the raw material and packaging materials
Purified Water Specification as per IP/BP/USP
Purified Water System
Purified Water System Validation
Purified Water Testing (Method of analysis) as per IP/BP/USP
Purified water testing in Pharmaceuticals
Raw Water Testing (Method of Analysis) as per IP/BP/USP
Requirements of Schedule L1 (Indian GLP) Good Laboratory Practice in Pharmaceutical
Resolution factor, Telling factor, Theoretical Plates and Capacity factor in HPLC
Retesting of raw materials
Rounding Off Values In GMP Documents in Pharmaceuticals
Rounding off figures of analytical results
Sampling procedure for purified water
Sampling, preservation and storage procedure of water sample
Size-Exclusion Chromatography
Specification for water for injection (WFI) as per USP
Tapped Density Tester
Terminology & Definitions in Pharmaceuticals
Test for Free Formaldehyde (Formaldehyde Content)
Test for Sulphated Ash and Total Ash
Testing procedure (Method of analysis) for Acetates,Acetyl Groups and Alkaloids

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2013 All rights reserved to Pharmaceutical Guidelines and may not be reproduced on other websites. Designed by Pharmaceutical Guidelines
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 Page 7 of 25
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Testing procedure (Method of analysis) for Aluminium Salts, Amines and Ammonium salts
Testing procedure (Method of analysis) for Antimony, Arsenic and Barium Salts
Testing procedure (Method of analysis) for Benzoates, Bicarbonates and Bismuth Compounds
Testing procedure (Method of analysis) for Bromides, Calcium Salts and Carbonates
Testing procedure (Method of analysis) for Chlorides, Citrates and Esters
Testing procedure (Method of analysis) for Ferric salts, Ferrous Salts and Iodides
Testing procedure (Method of analysis) for Lactates, Lead Compounds and Magnesium Salts
Testing procedure (Method of analysis) for Mercury Compounds, Nitrates and Phosphates
(Orthophosphates)
Testing procedure (Method of analysis) for Potassium Salts, Salicylates and Silicates
Testing procedure (Method of analysis) for Silver Compounds, Sodium Salts and Sulphates
Testing procedure (Method of analysis) for Sulphur in Organic Compounds, Tartrates and
Thiosulphates
Testing procedure (Method of analysis) for Xanthines and Zinc Salts
Thin-Layer Chromatography (TLC Method and Apparatus)
Types of water used in pharmaceutical processes
UV Cabinet Calibration in Pharmaceuticals
UV Light Efficiency Test
Ultrasonic bath
Ultraviolet and Visible Absorption Spectrophotometer (Apparatus and Calibration)
Uniformity of Weight of Single-Dose Preparations
Update on Schedule L1
Vacuum pump
Validation of excel calculation sheets
Viscometer calibration
WHO SOP list for Pharma Quality Control
WHO SOP list for Pharma Quality Control Cleaning
WHO SOP list for Pharma Quality Control Operations
Water Content Determination by Karl Fischer
What is Loss on Drying ? and Determination of Loss on Drying
cGMP guidelines for pharmaceutical industries part-1
cGMP guidelines for pharmaceutical industries part-2
pH Values (Apparatus and Method of Determination)

Guidelines for Microbiology

An overview of ISO 14644 clean room classification

Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals
Assay of Biotin or Vitamin B7 (Biological method) in Pharmaceuticals
Assay of Folic Acid or Vitamin B9 (by microbiological method)
Autoclave Validation in Pharmaceuticals
BET: Bacterial Endotoxin (LAL)Test.
Bacterial Endotoxin Test (BET or LAL Test) Validation
Bacterial Endotoxin Test Methods
Biocontamination control techniques for purified water sysem

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2013 All rights reserved to Pharmaceutical Guidelines and may not be reproduced on other websites. Designed by Pharmaceutical Guidelines
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 Page 8 of 25
Keep this document always with you, this will always help you to learn about pharmaceuticals. Ver.- 1.2
Biological Indicator for Dry Heat Sterilization Processes
Biological Indicator for Moist Heat (Steam) Sterilization Processes
Calibration of Heating block
Calibration of Micropipettes
Calibration of Microscope
Chemical Sanitization of RO Systems and Biofilm Removal
Clean Room System in Sterile Pharmaceutical
Clean Rooms And Controlled Areas (Sterile Area Classification)
Cleaning and Disinfection of a Newly Purified water system before Start Up
Culture Media
D value, Z value and F0 value calculations
Destruction of microbial waste
Difference among calibration, validation & qualification
Disinfectant Efficacy Test
Effectiveness of Antimicrobial Preservatives in Pharmaceutical Drugs
Endotoxin Detection by End-Point Chromogenic Method
Endotoxin Detection by Gel-Clot Limit Test Method
Endotoxin Detection by Gel-Clot Methods
Endotoxin Detection by Kinetic Thrbidimetric and Kinetic Chromogenic Methods
Endotoxin Detection by Quantitative Methods
Endotoxin Detection by Semi-Quantitative Gel-Clot Method
GMP Audit Check List- Equipment
GMP Audit Check List- Filling and Packaging
GMP Audit Check List- Personnel and Premises
GMP Audit Check List- Process Validation
GMP Audit Check List- Sanitation and Hygiene
GMP Audit Check List- Storage of Starting Materials
GMP Audit Check List- Weighing and Dispensing
GMP Audit Check List- water supply system
GMP Observations in Production
Good Documentation Practices (GDP) in Pharmaceuticals
Good Laboratories Practice (GLP) in Pharmaceuticals
Growth Promotion Test
Guide To Inspections of High Purity Water Systems
HEPA filters used in pharmaceuticals
HVAC system validation tests
High-Efficiency Particulate Air (HEPA) and its significance in sterile pharmaceutical preparations
How Sterilization is done by Filtration?
Identification of Environmental Flora
Investigation on sterility failure
Ionising Radiation Sterilisation
MLT (Microbial Limit Test) Validation
MLT: Microbial Limit Test
Maintenance of Microbial cultures
Media Fill Validation -SVP

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2013 All rights reserved to Pharmaceutical Guidelines and may not be reproduced on other websites. Designed by Pharmaceutical Guidelines
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 Page 9 of 25
Keep this document always with you, this will always help you to learn about pharmaceuticals. Ver.- 1.2
Media fill validation test in sterile pharmaceutical
Microbiological Assay of Cyanocobalamin or Vitamin B12
Mix Up and Cross Contamination in Pharmaceutical Manuacturing
Passivation of Purified water system/ WFI system in pharmaceuticals
Performance Evaluation of Biological Indicators
Performance Qualification Protocol for Sterilization and Depyrogenating Tunnel
Performance Qualification of Autoclave cum Bung Processor
Performance Qualification of High Pressure High Vaccum (HPHV) Steam Sterilizer in
Pharmaceuticals
Personnel monitoring of sterile area
Preservative Efficacy Test
Prevention of Cross - contamination during Processing
Prevention of Cross- contamination by HVAC in Pharmaceuticals
Prevention of Cross- contamination in Pharmaceuticals
Procedure for air sampling (environmental monitoring) in sterile pharmaceutical manufacturing
area
Procedure for garment change and entry and exit through first and primary change room
Protocol for hold time study of prepared control standard endotoxin (CSE)
Purified Water System
Purified Water System Validation
Pyrogens Testing in Pharmaceuticals
Qualification of systems and equipments in pharmaceuticals
Requirements of Schedule L1 (Indian GLP) Good Laboratory Practice in Pharmaceutical
SOP procedure for preparation and Bioburden monitoring of IPA 70% V/V
Sampling procedure for purified water
Sampling, preservation and storage procedure of water sample
Steam sterilisation (Heating in an autoclave)
Sterility testing procedure
Sterlity Validation (Membrane Filtration) in Pharmaceuticals
Types of Biological Indicators
Types of water used in pharmaceutical processes
Update on Schedule L1
Validation in pharmaceutical manufacturing
Validation of Dry Heat Sterilizer (DHS)
Validation of Supporting Processes in Pharmaceuticals
Validation of shelf life for 70% v/v isopropyl alcohol (IPA)
WHO SOP list for Pharma Microbiology
WHO: Water for pharmaceutical use
What WHO says about cross-contamination?
What is HEPA filter? Its use in Pharma
cGMP guidelines for pharmaceutical industries part-1
cGMP guidelines for pharmaceutical industries part-2
cGMP regulations for finished pharmaceuticals and medical devices

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2013 All rights reserved to Pharmaceutical Guidelines and may not be reproduced on other websites. Designed by Pharmaceutical Guidelines
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 Page 10 of 25
Keep this document always with you, this will always help you to learn about pharmaceuticals. Ver.- 1.2
Guidelines for Production

30 common ways to avoid making the most frequent GMP errors

Biocontamination control techniques for purified water sysem
Chemical Sanitization of RO Systems and Biofilm Removal
Clean Room System in Sterile Pharmaceutical
Clean Rooms And Controlled Areas (Sterile Area Classification)
Cleaning Validation Protocol for Pharmaceuticals
Cleaning Validation in Pharmaceuticals
Cleaning Validation of Pharmaceutical Equipments
Cleaning and Disinfection of a Newly Purified water system before Start Up
Concept of Revalidation in Pharmaceuticals
Difference among calibration, validation & qualification
Dry granulation process
Film coating process in pharmaceuticals
Film coating process of tablets in pharma manufacturing
GMP Audit Check List- Equipment
GMP Audit Check List- Filling and Packaging
GMP Audit Check List- Personnel and Premises
GMP Audit Check List- Process Validation
GMP Audit Check List- Sanitation and Hygiene
GMP Audit Check List- Storage of Starting Materials
GMP Audit Check List- Weighing and Dispensing
GMP Audit Check List- water supply system
GMP Observations in Production
Good Documentation Practices (GDP) in Pharmaceuticals
Granulation and particle-bonding mechanism of granulation
Guideline for pharmaceutical packing operation
High-Efficiency Particulate Air (HEPA) and its significance in sterile pharmaceutical preparations
Hold time study of cleaned equipments
List of Standard Operating Procedures (SOPs) in Production
Media Fill Validation -SVP
Media fill validation test in sterile pharmaceutical
Mix Up and Cross Contamination in Pharmaceutical Manuacturing
Non-sterile Process Validation in Pharmaceuticals
Operating Procedure for Weighing Balances
Operation and Cleaning of Machanical Sifter
Operation and Cleaning of Octagonal Blender
Operation and Cleaning of Roll Compector
Operation and Cleaning of Tablet Deduster Machine
Operation and Cleaning of Tablet Inspection Machine
Operation and Cleaning of Tray Dryer
Passivation of Purified water system/ WFI system in pharmaceuticals
Pharmaceutical Analytical Method Validation With Definitions
Prevention of Cross - contamination during Processing

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 Page 11 of 25
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Prevention of Cross- contamination by HVAC in Pharmaceuticals
Prevention of Cross- contamination in Pharmaceuticals
Procedure for Operation and Cleaning of Metal Detector
Procedure for Operation and Cleaning of Rapid Mix Granulator (RMG)
Procedure for garment change and entry and exit through first and primary change room
Procedure for in process checking during off-line and on line packing in pharmaceuticals
Procedure for line clearance before commencing any manufacturing operation
Purified Water System
Purified Water System Validation
Purpose of Process Validation in Pharmaceuticals
Sugar coating process and its problems in pharmaceuticals
Tablet coating problems and their solutions in pharmaceuticals
Terminology & Definitions in Pharmaceuticals
Tooling of Oral Solid Dosage Form (Tablet)
Types of water used in pharmaceutical processes
Validation in pharmaceutical manufacturing
Validation of Supporting Processes in Pharmaceuticals
WHO Qualification List for Pharmaceutical Equipments
WHO SOP list for Pharma Production
Wet Granulation Process
What WHO says about cross-contamination?
cGMP guidelines for pharmaceutical industries part-1
cGMP guidelines for pharmaceutical industries part-2
cGMP regulations for finished pharmaceuticals and medical devices

Standard Operating Procedures (SOPs) for Pharmaceuticals

SOP For Operation And Calibratioin of Polarimeter

SOP For Analysis And Release of Finished Sample
SOP For Backup/Restore And Archival of Analytical Data,In Electronic Form
SOP For Calibration Of Colony Counter
SOP For Calibration Of Glasswares
SOP For Calibration Of Hot Air Oven
SOP For Calibration Procedure of BOD / Bacteriological Incubator
SOP For Calibration of UV-Vis Spectrophotometer
SOP For Cleaning And Operation of Horizontal Autoclave
SOP For Cleaning And Operation of Verticle Autoclave
SOP For Cleaning Of Quality Control Laboratory
SOP For Cleaning Of Refrigerator
SOP For Cleaning Of Sampling Equipment
SOP For Cleaning and sterilization of glassware used in microbiology lab .
SOP For Cleaning of microbiology lab
SOP For Control of Record of Analysis
SOP For Entry/Exit Procedure For Quality Control Laboratory

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 Page 12 of 25
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SOP For Good Laboratory Practice
SOP For HPLC Analysis And Documentation
SOP For Handling Of Glassware
SOP For Identification Of Micorganisms
SOP For Laminar Flow Workbench
SOP For Maintenance Of Desiccator
SOP For Media Preparation And Growth Promotion Test
SOP For Monitoring Of Raw And Potable Water Quality
SOP For Operating Procedure For Air Sampler
SOP For Operation And Calibration Of FT-IR Spectrometer
SOP For Operation And Calibration Of Hot Air Oven
SOP For Operation And Calibration Of Leak Test Apparatus
SOP For Operation And Calibration Of Refractometer
SOP For Operation And Calibration Of Tap Density Apparatus
SOP For Operation And Calibration Of Vernier Caliper
SOP For Operation And Calibration Of Water Bath
SOP For Operation And Calibration Of pH Meter (Pico+)
SOP For Operation And Calibration of Auto Titrator (Metrohm)
SOP For Operation And Calibration of Microscope
SOP For Operation And Calibration of Sieve Shaker
SOP For Operation Of C/75 % RH)Control Envronment Chamber (40
SOP For Operation Of Milli- Q Water System
SOP For Operation Of Muffle Furnace
SOP For Operation Of UV Cabinet
SOP For Operation and Calibration of Melting Point Apparatus
SOP For Operation of Bacteriological Incubator
SOP For Operation of C/75 % RH)Control Envronment Chamber (30
SOP For Operation of HPLC System Using Chemistation Software
SOP For Operation of UV- Visible Spectrophotometer
SOP For Preparation And Standardisation Of Volumetric Solution
SOP For Preparation Of Standard, General Reagent And Indicator Solution
SOP For Preparation of Culture Of Microorganism
SOP For Preventive Maintenance Of Instrument
SOP For Procedure For Glasswares Washing
SOP For Procedure For Opening of Lyopholized Vial of Microorganism
SOP For Qualification of Facility/Equipments/Systems
SOP For Recrding of Analytical Data In Raw Data Sheet
SOP For Safety Measurs of QC Laboratory
SOP For Sampling Of Raw Material
SOP For Storage Of Sampling Tool
SOP For The Enumeration of Spore Count In Biological Indicators
SOP For Validation Of Autoclave With Biological Indicator For Sterilization Efficiency
SOP For Washing Of HPLC Column

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 Page 13 of 25
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SOP For handling of market complaints
SOP for Antimicrobial effectiveness testing
SOP for Bacterial Endotoxin Test
SOP for Clean Inspection of media fill vials and qualification of inspectors
SOP for Cleaning and Operation of Anaerobic Culture Jar
SOP for Cleaning and sanitization of Microbiology lab
SOP for Cleaning of Glassware
SOP for Cleaning of Glassware for Microbiological testing
SOP for Collection and Testing of samples during Process Simulation
SOP for Deaeration of Dissolution media
SOP for Dispensing and Issuance of Raw Material
SOP for Disposable of mediafill vials after incubation
SOP for Disposal of Contaminated Material
SOP for Disposal of media fill vials
SOP for Entry and Exit procedure for microbiology testing area and Sterility testing area
SOP for Entry and exit in Microbiology testing area
SOP for Handling and Storage of Raw & Packing Material
SOP for Handling of Market Complaints in Pharmaceuticals
SOP for Identification of microbial cultures using biomeriux identification system
SOP for Investigation on sterility failure, which is required to find out the route cause, and to
take the appropriate actions for future analysis
SOP for Karl Fischer apparatus
SOP for L.O.D. oven
SOP for Microbial Limit Test of Raw material and Finished product
SOP for Microbial analysis of swab samples from equipment surfaces
SOP for Microbial assay
SOP for Microbial staining procedures
SOP for Microbiology start up procedure after shut down
SOP for Monitoring of Compressed Air/Gases for Microbiological, Non-Viable Particulate, Oil
and Moisture Content
SOP for Monitoring of microbiology laboratory
SOP for Operating and cleaning of distilled water unit
SOP for Operation & Maintenance Of Fogger
SOP for Operation and Calibration of Analytical Balance
SOP for Operation and Calibration of Conductivity meter
SOP for Operation and Calibration of Conductivity meter
SOP for Operation and Calibration of Micropipette
SOP for Operation and Calibration of Top Pan Balance
SOP for Operation and Calibration of pH meter
SOP for Operation and Cleaning of Air Sampler SAS 180 L
SOP for Operation and Cleaning of Colony Counter
SOP for Operation and Cleaning of Deep Freezer
SOP for Operation and Cleaning of Garment Cubicle

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 Page 14 of 25
Keep this document always with you, this will always help you to learn about pharmaceuticals. Ver.- 1.2
SOP for Operation and Cleaning of Incubator
SOP for Operation and Cleaning of Microscope
SOP for Operation and Cleaning of Microscope
SOP for Operation and Cleaning of Pass box
SOP for Operation and Cleaning of Steam Sterilizer
SOP for Operation and Cleaning of Triobloc
SOP for Operation and Cleaning of Vertical Portable Autoclave
SOP for Operation and Maintenance of Fogger
SOP for Operation and Maintenance of Sterilization Reel Sealer
SOP for Operation and Maintenance of Water Purification System
SOP for Operation and Performance qualification of Biomerieux Kit (mini API, Densimat and
Electronic pipette)
SOP for Operation and calibration of leak tester
SOP for Operation of Milliflex Water filtration Unit
SOP for Operation of Rady Count Down Timer
SOP for Operation, Cleaning and Monitoring of Bio-Safety Cabinet
SOP for Operation, Cleaning and Monitoring of Laminar Air Flow
SOP for Operation, Maintenance & Calibration of Heating Block
SOP for Personnel Qualification of personnel entering into Aseptic area and Sterility Testing area
SOP for Planning for analysis and reporting of result
SOP for Post Sterility Growth Promotion Test
SOP for Preparation of Culture Inoculum
SOP for Preparation of Trends
SOP for Preparation, Review and Approval of Standard Operating Procedures
SOP for Procedure For Bioburden, BET, And LPC Of Primary Packaging Materials
SOP for Procedure for Bacterial Endotoxin (LAL) test
SOP for Procedure for Changeovers carried out in Manufacturing and Packing area
SOP for Procedure for Die Blocking
SOP for Procedure for Handling Of Out Of Specification Results In Microbiological Testing
SOP for Procedure for Handling of Out Of Limit Results in Environmental Monitoring and
Water Analysis.
SOP for Procedure for Manufacturing of Tablets & Capsules
SOP for Procedure for Operation of Air Sampler
SOP for Procedure for Operation of Deduster Cum Metal Detector
SOP for Procedure for Operation of Tablet Branding Machine
SOP for Procedure for Operation, Calibration, and System Suitability of Total Organic Carbon
(TOC) Analyser
SOP for Procedure for Receipt of Raw and Packing Material
SOP for Procedure for Stereo Ordering, Issue, Receipt & Destruction of Rubber Stereos
SOP for Procedure for Storage and Preparation of Microbiological Culture Media
SOP for Procedure for Testing of Biological Indicators
SOP for Procedure for analysis of Water
SOP for Procedure for preparation of dresses for sterilization.

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 Page 15 of 25
Keep this document always with you, this will always help you to learn about pharmaceuticals. Ver.- 1.2
SOP for Procurement, Maintenance and Sub-culturing of Standard Microbial Cultures
SOP for Sampling and Testing of Pure Steam
SOP for Sterility Testing By Membrane Filtration Method
SOP for Sterility Testing Using Manifold For Dilution Study and Stability
SOP for Sterility testing of compressed air, Nitrogen & Carbon dioxide
SOP for Sterility using Streitest Equinox
SOP for Sterilization by Autoclaving for Microbiological testing
SOP for Swab sampling for validation of test surface to evaluate cleaning efficacy.
SOP for Temperature, Humidity and Differential Pressure Monitoring
SOP for Testing of Particulate Matter in Injections and Operation and Maintenance of Liquid
Particle Counter
SOP for Validation Process For Checking Effectiveness Of Disinfections / Cleaning Procedure
SOP for a procedure for preparation of the volumetric solutions
SOP for action to be taken during unusual observation for instrument during calibration
SOP for allocating identification number to instrument/ equipment
SOP for autoclave
SOP for bacteriological incubator
SOP for behaviour in quality control department
SOP for calibration Total Organic Carbon (TOC) Analyser
SOP for calibration coulter counter
SOP for calibration of HPLC column oven
SOP for calibration of halogen moisture analyzer
SOP for calibration of pH meter temperature sensor
SOP for calibration of Atomic absorption spectrophotometer (AAS)
SOP for calibration of Autotitrator
SOP for calibration of Brook field viscometer
SOP for calibration of Gas chromatograph
SOP for calibration of HPLC (low pressure quaternary gradient liquid chromatograph)
SOP for calibration of Head Space Gas Chromatograph
SOP for calibration of Mercury filled glass thermometer
SOP for calibration of Micropipettes
SOP for calibration of Polarimeter
SOP for calibration of automatic box compression strength tester (digital model)
SOP for calibration of autotitrator
SOP for calibration of balance
SOP for calibration of balance
SOP for calibration of bursting strength tester
SOP for calibration of conductivity TDS meter
SOP for calibration of conductivity meter
SOP for calibration of disintegration test apparatus
SOP for calibration of glassware
SOP for calibration of hardness tester
SOP for calibration of high performance thin layer chromatography

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 Page 16 of 25
Keep this document always with you, this will always help you to learn about pharmaceuticals. Ver.- 1.2
SOP for calibration of infrared moisture balance
SOP for calibration of infrared spectrophotometer
SOP for calibration of karl fischer apparatus
SOP for calibration of melting point apparatus
SOP for calibration of pipettes, burettes and volumetric flasks used in Quality control
SOP for calibration of plunger operated pipette
SOP for calibration of refractometer
SOP for calibration of refractometer
SOP for calibration of slit to agar air sampler
SOP for calibration of the refractometer
SOP for calibration of walk-in- incubators 20-25c and 30-35c
SOP for calibration pH meters
SOP for calibration procedure of u.v.cabinet
SOP for calibration programme
SOP for careful handling of poisonous chemicals
SOP for centrifuge machine
SOP for check suitability of dissolution test apparatus
SOP for check the Fertility properties of the procured Media
SOP for cleaning
SOP for cleaning and disinfection
SOP for cleaning and c)c- 35operation of BOD incubator (30
SOP for cleaning and operation of RLAF unit in Sampling Room
SOP for cleaning and operation of bio- safety cabinet
SOP for cleaning and operation of incubator
SOP for cleaning and sanitization of microbiology section
SOP for cleaning for DHS
SOP for cleaning in microbiology section
SOP for cleaning of Autodiluter
SOP for cleaning of Dispensing & Sampling Room
SOP for cleaning of Halogen Moisture Analyser
SOP for cleaning of Metrohm Karl fisher
SOP for cleaning of Quality Control Dept. throughout working
SOP for cleaning of Vertical Autoclave
SOP for cleaning of autoclave
SOP for cleaning of automatic distillation apparatus
SOP for cleaning of box compression strength tester
SOP for cleaning of colony counter
SOP for cleaning of disintegration test apparatus
SOP for cleaning of disintegration test apparatus
SOP for cleaning of dispensing utensils
SOP for cleaning of dissolution tester
SOP for cleaning of fourier transform infrared spectrophotometer
SOP for cleaning of friability test apparatus

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 Page 17 of 25
Keep this document always with you, this will always help you to learn about pharmaceuticals. Ver.- 1.2
SOP for cleaning of high performance liquid chromatography (HPLC)
SOP for cleaning of melting point apparatus
SOP for cleaning of microscope
SOP for cleaning of oven for incubator at 55c
SOP for cleaning of oven for depyrogenation
SOP for cleaning of slit to agar air sampler
SOP for cleaning of steritest
SOP for cleaning of tablet hardness tester
SOP for cleaning of tap density apparatus
SOP for cleaning procedure for karl fischer apparatus
SOP for cleaning procedure for Alu-Alu Packing Machine
SOP for cleaning procedure for Automatic Cartoning Machine
SOP for cleaning procedure for Automatic Coating System
SOP for cleaning procedure for Bins & HDPE Containers
SOP for cleaning procedure for Blister Packing Machine
SOP for cleaning procedure for Checkweigher
SOP for cleaning procedure for Colloidal Mill
SOP for cleaning procedure for Conveyor Belt
SOP for cleaning procedure for Deblistering machine
SOP for cleaning procedure for Deburring and Dedusting Machine
SOP for cleaning procedure for Dehumidifier
SOP for cleaning procedure for Drum mixer
SOP for cleaning procedure for EPD Collator machine with strip packing machine line
SOP for cleaning procedure for Exhaust Ducts in Coating area
SOP for cleaning procedure for FBD Bag
SOP for cleaning procedure for Fluidised bed Dryer
SOP for cleaning procedure for Hose Pipe Of Dust Extraction System
SOP for cleaning procedure for Metal Detector
SOP for cleaning procedure for Mini roll compactor
SOP for cleaning procedure for Octagonal Blender
SOP for cleaning procedure for Paste Kettle
SOP for cleaning procedure for Pressure Vessel, Peristaltic Pump & spraying gun
SOP for cleaning procedure for Rapid Mixer Granulator (R.M.G.)
SOP for cleaning procedure for S.S. Vessel and Utensils
SOP for cleaning procedure for Semi-Automatic Cartoning Machine
SOP for cleaning procedure for Stirrer
SOP for cleaning procedure for Strip Packing Machine
SOP for cleaning procedure for Tablet Compression Machine
SOP for cleaning procedure for Vacuum Cleaner
SOP for cleaning procedure for Vibro Sifter
SOP for cleaning procedure for brooke field viscometer
SOP for cleaning procedure for cad mill
SOP for cleaning procedure for capsule filling cubicle

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2013 All rights reserved to Pharmaceutical Guidelines and may not be reproduced on other websites. Designed by Pharmaceutical Guidelines
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 Page 18 of 25
Keep this document always with you, this will always help you to learn about pharmaceuticals. Ver.- 1.2
SOP for cleaning procedure for capsule filling line
SOP for cleaning procedure for centrifuge
SOP for cleaning procedure for coulter counter
SOP for cleaning procedure for dissolution test apparatus
SOP for cleaning procedure for gas chromatograph (head space)
SOP for cleaning procedure for heating block
SOP for cleaning procedure for high performance thin layer chromatograph
SOP for cleaning procedure for microbiological laboratory other than clean area.
SOP for cleaning procedure for microscope
SOP for cleaning procedure for multi mill
SOP for cleaning procedure for pallet
SOP for cleaning procedure for polarimeter
SOP for cleaning procedure for refracto meter
SOP for cleaning procedure for semi auto induction cap sealing machine
SOP for cleaning procedure for tablet counter
SOP for cleaning procedure for u.v. /visible spectrophotometer
SOP for cleaning procedure for u.v. /visible spectrophotometer
SOP for cleaning procedure for ultrasonic bath
SOP for cleaning procedure for vacumme oven
SOP for cleaning procedure for water bath
SOP for cleaning procedure for water purification system
SOP for cleaning procedure for zone reader
SOP for cleaning procedure of atomic absorption spectrophotometer
SOP for cleaning procedure of balances
SOP for cleaning procedure of bursting strength tester
SOP for cleaning procedure of deep freezer
SOP for cleaning procedure of polariscope
SOP for cleaning procedure of puncture resistance tester
SOP for cleaning procedure of quardrant meter
SOP for cleaning procedure of sterile dress cabinate
SOP for cleaning procedure of water bath
SOP for cleaning, operation and calibration of Antibiotic Zone Reader
SOP for collection and storage of retained samples of packaging material
SOP for collection and storage of retained samples of raw material
SOP for collection of swab sample
SOP for control of master data generation by computer system
SOP for destroy the inprocess, finished product and raw materials samples timely after testing
SOP for destruction of control samples (Raw material and Finished product)
SOP for dispatch the Finished Goods out side the factory premises from BSR
SOP for dispensing and issuing of Packing Material as per the requirement from Production
Department
SOP for disposal of empty media conatiner
SOP for disposal of expired chemicals, reagents, solvents and micro-biological medium.

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 Page 19 of 25
Keep this document always with you, this will always help you to learn about pharmaceuticals. Ver.- 1.2
SOP for disposal of microbial culture media and cleaning of glassware used for culture media
SOP for disposal of rejected Packing Material
SOP for disposal procedure for media containing growth
SOP for entry and exit in Microbiological Testing Area (MLT/Sterility Room)
SOP for entry and exit in Microbiology Section
SOP for environmental monitoring of aseptic area by air sampling for viable count using air
sampler
SOP for environmental monitoring of dispensing and sampling area in raw materials
SOP for environmental monitoring of manufacturing area of solid dosage form by settling plate
count
SOP for environmental monitoring of solid dosage form area by non viable air particle count
SOP for environmental monitoring of walk-in-incubators
SOP for evaluation of compressed air in manufacturing of Pharmaceutical products
SOP for evaluation of environmental monitoring results (trend analysis)
SOP for for allocating document protocol number for instrument qualification
SOP for for measurement of particle size of raw materials using microscopic method
SOP for general test procedure
SOP for gowning procedure
SOP for gowning procedure for the visitors
SOP for growth promotion test and calibration of inoculum
SOP for guideline for storage condition of raw material
SOP for guideline for the system suitability test for HPLC analysis
SOP for guidelines for Microbiology laboratory
SOP for hand wash procedure
SOP for handling & usage of hazardous chemicals
SOP for handling and control for the prohibited items
SOP for handling and testing of inprocess sample
SOP for handling and testing of various samples
SOP for handling of biological indicators
SOP for handling of glassware
SOP for handling of reference and working standard
SOP for handling of spillage of solid/liquid media containing growth
SOP for handling of the spillages in the laboratory
SOP for heat distribution study in chamber of depyrogemation oven using different probe with
data logger
SOP for heat distribution study in chamber of dry heat sterilizer using different probe with data
logger
SOP for heat distribution study in oven using multi probe data logger
SOP for heating block validation
SOP for hplc column receipt checking and regeneration
SOP for identification of contaminant in sterile area
SOP for identification of organisms
SOP for instrument for macroscopical examination

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2013 All rights reserved to Pharmaceutical Guidelines and may not be reproduced on other websites. Designed by Pharmaceutical Guidelines
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 Page 20 of 25
Keep this document always with you, this will always help you to learn about pharmaceuticals. Ver.- 1.2
SOP for inventory and issuances of media in quality control lab
SOP for investigation for out of action level results of monitoring of micro biological environment
SOP for investigation of sterility test failure
SOP for laboratory cleaning
SOP for laboratory safety
SOP for lal test by gel clot method
SOP for laminar air flow workstation
SOP for leak seal test apparatus
SOP for leak test of strip, blister and alu alu blister sealing
SOP for logic for giving number to the method for analysis of finished product and raw material
SOP for logic for giving number to the method for analysis of packaging material
SOP for maintenance & cleaning procedure for sampling equipment
SOP for maintenance and transfer of stock cultures
SOP for maintenance of desiccator
SOP for manual glassware cleaning procedure
SOP for media disposal
SOP for media preparation
SOP for media preparation
SOP for media stock maintenance and suitability testing of media
SOP for method for programme file checks of software of instruments
SOP for metone laser particle counter
SOP for microbial limit test for raw materials and finished products
SOP for microbial monitoring of drainage in solid dosage manufacturing area
SOP for microbiological integrity testing of vials
SOP for microbiological monitoring of clean equipment in to solid dosage area. swab method
SOP for microscope
SOP for monitoring UV Light Efficiency LAF & Pass Box
SOP for muffel furnace
SOP for numbering system of media
SOP for operating procedure of Dehumidifier
SOP for operating procedure of colony counter
SOP for operating procedure of culture cabinet
SOP for operating procedure of data logger
SOP for operating procedure of double door autoclave
SOP for operating procedure of fogster ULV fogger machine
SOP for operating procedure of laminar air flow
SOP for operating procedure of water bath.
SOP for operation & calibration of digital Colony Counter
SOP for operation and calbration of dry bath
SOP for operation and calibration of bulk density apparatus
SOP for operation and calibration of bursting strength tester
SOP for operation and calibration of friability test apparatus
SOP for operation and calibration of pH meter (GMPH)

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 Page 21 of 25
Keep this document always with you, this will always help you to learn about pharmaceuticals. Ver.- 1.2
SOP for operation and calibration of pH meter (pH tutor)
SOP for operation and calibration of tablet disintegration apparatus
SOP for operation and calibration of vacuum oven
SOP for operation and cleaning of LAF unit in Sampling Room
SOP for operation and cleaning of Refrigerator
SOP for operation and monitoring of performance of dynamic pass box
SOP for operation and monitoring of performance of garment cabinet
SOP for operation of Laminar Air Flow
SOP for operation of centrifuge machine
SOP for operation of magnetic stirrer with hot plate
SOP for operation of micrometer
SOP for operation of particle counter
SOP for operation of sampling booth
SOP for operation of sonicator
SOP for operational check of disintegration test apparatus
SOP for operational check of friability test apparatus
SOP for operational qualification of dissolution tester
SOP for oven for depyrogenetion
SOP for oven for incubation at 55 deg c
SOP for palm swabbing
SOP for performance check of karl fisher
SOP for performance check of UV - visible spectrophotometer (Jasco)
SOP for performance check of UV/visible spectrophotometer
SOP for performance check of autodiluter
SOP for performance check of fourier transform infrared
SOP for performance checks of karl fischer apparatus
SOP for performance of low temperature water bath
SOP for personnel monitoring in aseptic area
SOP for physical monitoring of microbiology section
SOP for plate exposure
SOP for preparation and handling of primary standard
SOP for preparation and standardisation of volumetric solutions
SOP for preparation of Culture dilutions
SOP for preparation of Rejection Note
SOP for preparation of bench reagents
SOP for preparation of microbial culture media
SOP for preparation of sterile petridishes, agar slants and agar butts
SOP for preparation, approval, issue, control, uncontrol and revision of quality manual
SOP for preservation of Control samples of Active ingredients
SOP for procedure environmental monitoring of parenteral processing area : by settling plate
count method.
SOP for procedure for Handling of Lysate.
SOP for procedure for Material and Product Labeling in Production department

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 Page 22 of 25
Keep this document always with you, this will always help you to learn about pharmaceuticals. Ver.- 1.2
SOP for procedure for Operation and cleaning of Automatic Batch Printing Machine
SOP for procedure for Operation of Alu Alu blister pack machine
SOP for procedure for Operation of Automatic Capsule Filling Line
SOP for procedure for Operation of Automatic Coating System (NEOCOTA 48)
SOP for procedure for Operation of Batch Printing Machine (Semi Automatic)
SOP for procedure for Operation of Colloid Mill
SOP for procedure for Operation of Compression Machine 20 station (Single Rotary Type)
SOP for procedure for Operation of Compression Machine 27 station (Double Rotary Type)
SOP for procedure for Operation of Deblistering Machine
SOP for procedure for Operation of Deburring & Dedusting Machine
SOP for procedure for Operation of Drum mixer
SOP for procedure for Operation of Fluidised Bed Dryer
SOP for procedure for Operation of Multimill
SOP for procedure for Operation of Octagonal Blender (1000 liter)
SOP for procedure for Operation of Paste Kettle
SOP for procedure for Operation of Rapid Mixer Granulator (RMG)
SOP for procedure for Operation of Stirrer
SOP for procedure for Operation of Strip Packing Machine
SOP for procedure for Operation of Tablet Inspection machine
SOP for procedure for Operation of Vacuum Test Apparatus
SOP for procedure for Operation of Vibro Sifter
SOP for procedure for Operation of Volume Delivering Systems (Peristaltic Pump)
SOP for procedure for Ordering, Receiving, Storage, Issue, & Destruction of Dies & Punches
SOP for procedure for Packing of Tablets/Capsules in strip pack or blister pack as primary
packing & packing of strips or blisters in cartons, shipper as secondary packing
SOP for procedure for Pre Filter cleaning of RLAF
SOP for procedure for Receipt, Issuance, Storage and Handling of solvent
SOP for procedure for Tablet Inspection
SOP for procedure for Tablet granulation, compression and coating
SOP for procedure for action to be taken during spillage/breakage of materials
SOP for procedure for analyst validation
SOP for procedure for calibration of thermometer
SOP for procedure for challenge test of solid Flow Monitor in Fluid Bed Dryer
SOP for procedure for cleaning and storage of flexible pipes
SOP for procedure for cleaning of barrel pump & pipe
SOP for procedure for cleaning of clean area
SOP for procedure for cleaning of equipment and accessories in Production Area
SOP for procedure for conduct a temperature mapping exercise in store to identify the location of
the worst point at which the thermometer and hygrometer for daily monitoring needs to be placed
SOP for procedure for destruction of online rejects of printed and overprinted packaging
materials
SOP for procedure for disposal of wastage and transfer to ETP
SOP for procedure for entering in inoculation room

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 Page 23 of 25
Keep this document always with you, this will always help you to learn about pharmaceuticals. Ver.- 1.2
SOP for procedure for entering in sterility testing room
SOP for procedure for environmental monitoring of aseptic area :non viable particle count of air
SOP for procedure for environmental monitoring of aspetic area: finger prints and gown
sampling
SOP for procedure for environmental monitoring of clean area and LAF modules.
SOP for procedure for environmental monitoring of parenteral processing area : surface testing
by means of rodac plate and swab
SOP for procedure for evaluation of analysts performance
SOP for procedure for fumigation in microbiology lab
SOP for procedure for handling of Rejected Packing Materials
SOP for procedure for handling of Rejected Raw Material
SOP for procedure for handling of Tablet Counter
SOP for procedure for handling of sieves and screen
SOP for procedure for house-keeping of stores
SOP for procedure for issuance of additional packaging materials
SOP for procedure for linearity check of high performance liquid chromatograph
SOP for procedure for maintaining machine use log
SOP for procedure for making production related entries in SAP system
SOP for procedure for operating and cleaning of Vacuum Cleaner
SOP for procedure for operation and calibration of precision oven
SOP for procedure for operation and cleaning of Carton Sealing Machine
SOP for procedure for operation of Cad mill
SOP for procedure for operation of EPD Collator coupled with strip packing machine
SOP for procedure for operation of conveyor belt in packing
SOP for procedure for operation of mini roll compactor
SOP for procedure for operation of semi auto induction cap sealing machine
SOP for procedure for operation of Bliss, the online inspection system
SOP for procedure for overprinting of batch details on cartons and catch covers
SOP for procedure for performance of automatic distillation apparatus
SOP for procedure for preparation and handling of working standard
SOP for procedure for proper disposal of expired finished goods
SOP for procedure for receipt, numbering, usage and destruction of FBD filter bag
SOP for procedure for recleaning
SOP for procedure for reconciliation of Raw Materials and Packing Materials
SOP for procedure for recording of Temperature & Humidity in Stores Department
SOP for procedure for recording of Temperature and Humidity in Raw Material Store and
Temperature recording in Packing Material Store for maintaining proper storage conditions
SOP for procedure for recording of Temperature in Production Department
SOP for procedure for recording of differential pressure in Production area.
SOP for procedure for return of Raw & Packing materials from production department
SOP for procedure for safely and effectively clean and disinfect the drains
SOP for procedure for sampling and testing schedule of water for injection and clean steam
SOP for procedure for sampling of the packaging material

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 Page 24 of 25
Keep this document always with you, this will always help you to learn about pharmaceuticals. Ver.- 1.2
SOP for procedure for sieve analysis
SOP for procedure for stacking of packed shippers on pallet
SOP for procedure for stenciling of shippers used for packing
SOP for procedure for sterility testing
SOP for procedure for storage & transference of dispensed raw material in day store
SOP for procedure for storage of temperature sensitive raw materials
SOP for procedure for the Blister Pack Machine
SOP for procedure for the intimation of break down of utilities services & equipments in
manufacturing & packing department during working
SOP for procedure for the operation of Automatic Cartoning Machine
SOP for procedure for the operation of Semi-Automatic Cartoning Machine (VP-120)
SOP for procedure for the operation of checkweigher
SOP for procedure for the preventive maintenance of all quality control instruments
SOP for procedure for transfer of the finished goods to bonded store room
SOP for procedure for validation of microbiologist
SOP for procedure for vehicle Inspection
SOP for procedure for washing the HPLC column after use
SOP for procedure of fumigation in production area by using 5 % Gramicid and Fogger
SOP for procedure of sampling of raw material
SOP for procedure to specify the responsibilities of production department
SOP for procurement and handling of reference standard
SOP for proper disposal of contaminated material to ensure all media containing microbial
growth are disposed properly
SOP for qualification of Biological Indicator
SOP for quantification of culture
SOP for raw material release
SOP for receipt and maintenance of working standards of API
SOP for receiving the samples in microbiology lab
SOP for release of finished product
SOP for retesting of Raw Materials
SOP for retesting schedule of packaging material
SOP for retesting schedule of raw material
SOP for retesting schedule of raw material (for API)
SOP for rounding off the analytical test results
SOP for routine cleaning verifictaion by TOC-SSM method
SOP for safety in quality
SOP for sampling and release of Inprocess samples
SOP for sampling and release of raw materials
SOP for sampling and testing schedule of purified water
SOP for sampling of Finished product
SOP for sampling of packing material
SOP for sampling of water
SOP for selection criteria and its procedure before dissolution profile study

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2013 All rights reserved to Pharmaceutical Guidelines and may not be reproduced on other websites. Designed by Pharmaceutical Guidelines
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 Page 25 of 25
Keep this document always with you, this will always help you to learn about pharmaceuticals. Ver.- 1.2
SOP for slit to agar air sampler
SOP for statistical study for trend analysis of purified water and water for injection
SOP for steam penitration study by bowie-dick test
SOP for sterile dress cabinet
SOP for sterilization of accessories by dry heat sterilization
SOP for storage and use of reagents & chemicals
SOP for subculturing & maintenance of microbial cultures
SOP for testing & release/rejection of Finished product
SOP for testing for bioburden of fractional solutions
SOP for testing of compressed air and nitrogen gas for viable count
SOP for testing of miscellaneous sample
SOP for the procedure for Operation of Rapid Mixer Granulator
SOP for training procedure for qc persons
SOP for trend analysis
SOP for ultrasonic cleaner
SOP for use of logcard for equipment status
SOP for validation of DHS with biological indicator
SOP for validation of autoclave
SOP for validation of autoclave with biological-indicator
SOP for validation of clean area & equipment lying in clean area
SOP for validation of oven for depyrogeneation.
SOP for verification of system suitability test
SOP for verification of system suitability test measured by chrom card software for GC
SOP for vortex mixer
SOP for water sampling procedure
SOP for writing method of analysis for P.M
SOP of SOP (SOP on SOP) in Pharmaceuticals
SOP on Standard Operating Procedure
SOP procedure for preparation and Bioburden monitoring of IPA 70% V/V

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