Company

LOGO

PRODUCTION
(Chain of Operating Process, Personalia, Sanitation & Hygiene)

By Group 5

Pharmaceutical Industry

Group 5 members:
Hilda Shinta Yesi Haerunisa Frederika Burlani J. Erni Nurhayati Riska Muliatin Agus N Eka Perceka K. Dessy Kartika P. Fathurrahmi M. Panji 260112110582 260112110584 260112110586 260112110588 260112110590 260112110592 260112110594 260112110596 260112110598 260112110600

A CHAIN OF OPERATING PROCESSES

dry material n product

Mixing n granulating Compression Coating Hard capsul filling Coat tablet n caps printing

Liquids, Cream n Ointment

Should be produced so as to protect the product from m.o and other contamination Should be design n installed so they may be readily-cleaned and sanitized Use of glass apparatus should be avoided
The chemical and microbiological quality of the water used should be specified n monitored

Care should be taken when transfering material through pipelines Measuring system should be verified as accurate Maintain to homogenity Maximum periode of storage

Out-of-specification lots should not be blended with other lots for the purpose of meeting specifications The expiry dates of blended lots should be based on the manufacturing date of the oldest lots or left-over parts used in the blending.

Company

LOGO

Personalia

Principle

The establishment and maintance of a satisfactory system of quality assurance and correct manufacture of pharmaceutical products relies upon people

The Manufactur

should have an adequate number of personel with the necessary qualifications and practical experience

must have an organization chart

duties may be delegated to design ated deputies of a satisfactory qualification level

K E Y

Head of production

P E R S O N N E L

Head of quality control

Head of quality management (QA)

The production and quality assurance led by different people Head of Production let a Pharmacist Head Head of Quality Control and Head of quality management in priority of a Pharmacist

ORGANIZATION, QUALIFICATIONS AND RESPONSIBILITIES

Head of production

Make sure the drug is produced, stored according to procedure Approve the work associated with the production Ensure the production of records, evaluation, Signed Inspect the building maintenance section of production facilities and equipment Ensure that appropriate validation Ensure that initial and continuing training for personnel

Head of quality control

Accept / reject starting materials, packaging materials, intermediate products, bulk products and finished product Ensure that all testing Approval of work sampling, testing methods and other quality control procedures Approve and monitor all contract analysis Inspect buildings, facilities and equipment Ensure that the validation has been carried out Ensure continuous training of personnel beginning

QUALITY SYSTEM RESPONSIBILITY OR INVOLVEMENT

QA
Site Quality Systems: SOPs and Document Control Master and Production Batch Records Batch Record Review and Product Release Failure Investigations and CAPA Training Site Change Control Validation (Facilities, Equipment, and Computer) Supplier Management and Control Complaints Annual Product Review Management Notification

QC
Laboratory Systems (QC and Stability): Sample Management Reference Standards SOPs and Test Methods Method Validation and Transfer Instrument Qualification/Calibration and Maintenance Data Analysis, Records, and Document Control Change Control Contract Laboratory Management

Business Knowledge/ Understanding

Policies/Standards/Regulations Manufactured Products Pharm/Bio Industry Knowledge (Rx, OTC) local Global General Business (Mfg., Logistics, TS, Eng.) HR, Finance, Marketing/Sales, IS

Leadership & management sklills

Facilitiation and Training Positive Regard and Motivation Performance Assessment/Feedback/Coaching Team Building Networking

Quality system
Policies/Procedures Annual Product Review (APR) Complaints Failure Investigations/Materials Decisions Product Release Change Control Components, Materials/Warehousing/Dist. Calibration & Maintenance Management Notification Training Recall Technology Transfer

Quality design & prevention

Basic Quality Tools Process Capability and Statistical QC Process/System Design Design of Experiments (DOE) Failure Mode Effect Analysis (FMEA) Value Engineering/Analysis & Re Engineering Benchmarking

Plan of Training
an individuals curriculum or training topics or courses how the training will be performed the sequence of the training approximate training time a clear indication of when the individual will be fully qualified

Training
Provided to : 1. All personnel in manufactur 2. Beside the basic training, newly personnel should received training appropriate to duties assigned to them . 3. Personnel who work in contamination is harzard areas . 4. Visitor an untrained personnel not be taken to production and QC areas.

Contd
5. The concept of QA and all the measures capable of improving its understanding and implementation should be discussed during the training . 6. Training should be conducted by qualified individuals .

CPOB Training -Level of training

GMP

1. Training all personnel who duties in these company 2. Training appropriate to the duties assigned to them 3. Personel working in areas where contamination is hazard

1. Broad general knowledge, introduction to GMP section 2. Application of specific GMPs to the Functional Area 3. Application of GMPs to a Spercific Job given by qualified personnel, the company should have a procedure and process for qualifying trainers.

- Qualified training
Conducted by qualified individuals

Contd .
- Training materials Training materials should be version-controlled, and if developed in conjunction with an SOP, reviewed, and updated, if required, when the SOP is updated or reviewed. -

Personnel

Head of Quality

Duties may be delegated to a design deputies of a satisfactory qualification level. A qualified and preferably a A qualified person and must pharmacist be pharmacist

QC

Make sure the drug is Laboratory Systems (QC and produced and stored according Stability): to the procedure Sample Management Reference Standards Approve production work SOPs and Test Methods Method Validation and Evaluation of production Transfer records Instrument Qualification/Calibration and Check building production Maintenance facilities and equipment; Data Analysis, Records, and Document Control validation Change Control Contract Laboratory Initial and continuing training Management

QA

Implementation of quality systems Establishment of reference quality Internal audit or periodic selfinspections Quality Control;

External audits (audits of suppliers);

Validation; Ensuring the technical requirements of the OPO Reviewing batch records Pass or reject finished products

Site Quality Systems: SOPs and Document Control Master and Production Batch Records Batch Record Review and Product Release Failure Investigations and CAPA Training Site Change Control Validation (Facilities, Equipment, and Computer) Supplier Management and Control Complaints Annual Product Review Management Notification

SANITATION AND HYGENE

PRINCIPLE
The scope of sanitation and hygene covers : 1. Personal 2. Premises 3. Equipment and Apparatus 4. Production materials and Containers 5. Potential source of contamination (Pedoman CPOB, 2006).

PERSONAL HYGIENE
Wear protective garments appropriate to the operations Wear clean body-coverings appropriate hair covering. Soiled uniforms and clean clothes should be stored in separate closed containers until properly laundered.

PERSONAL HYGIENE
Detailed hygiene programmes:
procedures relating to the health hygine practices and clothing of personnel.

All personnel should

receive medical examination upon recruitment be instructed to use the hand washing facilities practice good personal hygiene

PERSONAL HYGIENE
Sick person should not be allowed to handle starting materials, packaging materials, in-process materials, and pharmaceutical products until the condition in improved. Avoid direct contact between operators hand and the exposed starting materials, intermediate and bulk process

PERSONAL HYGIENE
Smoking, eating, drinking, chewing or keeping plant, storage of food, drink, smoking material or personal medicines:
restricted to specific areas not permitted in production, laboratory, storage areas and other areas where they might adversely influence product quality (Pedoman CPOB, 2006).

PREMISES SANITATION
should be suitably designed and constructed to facilitate good sanitation. employees washing and well ventilated toilet facilities should be provided and easily accessible to manufacturing areas. Should provide suitable facilities for storage of employee clothing and personal property

PREMISES SANITATION
The preparation, storage and consumption of food and beverages should be restricted only to specific areas, such as lunch room
Waste material should not be allowed to accumulate

PREMISES SANITATION
Rodenticides, insecticides, fumigating agents and sanitizing materials should not be permitted to contaminate equipment, starting materials, packaging materials, inprocess materials or finished product
There should be a written procedures for the use of it

PREMISES SANITATION
should be a written procedures assigning responsibility for sanitation (the written procedures should be followed) Sanitation procedures should apply to work performed by full-time employees, contractors or temporary employees
Any unhygienic practice within the manufacturing areas or in any other area where the product might be adversely affected should be forbidden (Pedoman CPOB, 2006).

PREMISES SANITATION
Attention should be paid especially to cleaning and the maintenance space as well as prevention of cross-contamination (Hiyama et al., 2005).

EQUIPMENT CLEANING AND SANITATION

Equipment should be cleaned both inside and outside Vacuum or wet cleaning methods are to be preferred Cleaning and storing of mobile equipment and storing of cleaning materials should be done in rooms separated from processing areas

EQUIPMENT CLEANING AND SANITATION Written procedures in sufficient detail should be established, validated and followed for cleaning and sanitizing equipment and containers used in the manufacture of pharmaceutical products

EQUIPMENT CLEANING AND SANITATION Record of cleaning, sanitizing, sterilization and inspection prior to use should be kept properly. Disinfectants and detergents should be monitored for microbiological contamination (Pedoman CPOB, 2006).

EQUIPMENT CLEANING AND SANITATION Washing facilities should be equipped with hot and cold water as appropriate, soap or detergent, air driers or single service towels. The washing and toilet facilities should be separated from, but easily accessible from, manufacturing areas.

EQUIPMENT CLEANING AND SANITATION When necessary, an appropriate facility for taking a shower and changing clothes should be installed (Hiyama et al., 2005).

VALIDATION OF CLEANING AND SANITATION PROCEDURES

the cleaning, sanitation and hygiene procedures should be validated and periodically assessed to ensure that the effectiveness of the procedures meet the requirements (Pedoman CPOB, 2006).

VALIDATION OF CLEANING AND SANITATION PROCEDURES Cleaning, sanitization and sterilization of equipment to be cleaned should be appropriate operations in consideration of microbiological and endotoxin contamination in the process where control of total microbiological count or endotoxins in the product is required during manufacturing, or in other processes where such contamination could be of concern (Hiyama et al., 2005).

DAFTAR PUSTAKA
BPOM RI. 2006. Pedoman Cara Pembuatan Obat yang Baik. Jakarta: BPOM RI. Hiyama, Yukio. 2006. GMP Guideline for Drug Product.