28/9/2017 SOP for Sampling and Release of Raw Materials : Pharmaceutical Guidelines

SOP for Sampling and Release of Raw Materials

Standard operating procedure for sampling and release of approved Raw Material.
1.0 OBJECTIVE
To lay down the clear procedure for sampling and release of raw materials.
2.0 SCOPE
This procedure is applicable for the sampling and release of all raw materials received at API Raw Material Stores.
3.0 RESPONSIBILITY
3.1 Doing : Technical Assistant
3.2 Checking : Executive/ Manager
4.0 ACCOUNTABILITY
Head of the Department
5.0 PROCEDURE
5.1 Precaution
5.1.1 Use Clean and dry sampling device for sampling.
5.1.2 Use different sampling devices for sampling of different materials.
5.1.3 For sampling of volatile and hazardous chemicals and solvents, follow instructions as given in their handling procedures.
5.2 Receive the MATERIAL RECEIVING NOTE in triplicate from the stores and enter the following details in the raw material log register maintain
separately for API Raw Material in Q.C. Department.
Name of the Material
Batch No. (If available)
Mfg. Date/Exp. Date (If available)
Manufacturers/ Suppliers Name
Quantity received
Date of receipt
A.R. No.
Store Ref. No.
5.3 Sampling Container

5.3.1 Select the sample containers according to the nature of the material to be sampled as step 5.3.2 & 5.3.3.
5.3.2 Use clean fresh polyethylene bag for solid materials.
5.3.3 Use clean and dry glass bottle or stoppered flask for solvents and liquids.
5.4 Sampling Device

5.4.1 Use stainless steel sampling device specially designed for solid and liquid material.
5.4.2 For solid materials use specially designed Stainless Steel sampling device by which material can be sampled from different level (Thief
sampler)
5.4.3 For liquid, use specially designed Stainless Steel drum sampler.
5.4.4 Clean the sampling devices first with raw water and then wash with plenty of D.M. water and dry in air or wipe with tissue paper and store the
sampling devices in a separate drum.
5.5 Sampling Preparation
5.5.1 Assign the work of sampling of the material to the QC chemist authorized for sampling of the materials.
5.5.2 Check the details on the MATERIAL RECEIVING NOTE and enter the details in computer for UNDER TEST labels as follow.
Name of Material :
Material code No :
A.R. No :
Sampled by : (Initial of the QC chemist will be done at the time of pasting labels on container)
Date :
Container No :
Sampled Qty. :
5.5.3 Prepare and send the sample withdrawal slip to Raw Material store for quantity of material to be sampled.
5.5.4 Ensure that containers are cleaned externally, Before bringing of the material to be sampled to the sampling area in the store.
5.5.5 Check the details given on the Material Receiving Note with the suppliers label on the raw material containers and the label affixed by the
stores.
5.5.6 Any discrepancy found should be immediately brought to the notice to the Q.C. Executive/ Manager and store incharge.
5.6 Damaged Container

5.6.1 Check the physical condition and cleanliness of raw material containers before opening for sampling.
5.6.2 Damage containers whose integrity is doubtful should be sampled separately and kept aside with a separate A.R. No.
5.7 Safety Precautions
5.3.2 Cover the hands with gloves and wear a cap, safety goggles, mask and safety shoes while doing the sampling of toxic and hazardous
chemicals & while doing the sampling from the tankers.

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28/9/2017 SOP for Sampling and Release of Raw Materials : Pharmaceutical Guidelines

5.7.2 Clean the hands with plenty of water after completion of sampling and dry the hands witha neat & clean towels or air dry.
5.8 Sampling

5.8.1 Carry out sampling of all raw materials from different containers in each given A.R. Nos.
According to formula n + 1 e.g. for 10 containers sample from 10 + 1 = 4 containers.
5.8.2 Use the sampling device for sampling from Cleaned container.
5.8.3 Record the no. of container from which sample is drawn.
5.8.4 Draw the sample from different levels (i.e. From Top, middle & bottom) of the container. The weight of the sampled quantity should be about
Raw Material Solid/Liquid = 50gm
Raw Material Solvent = 250ml
5.8.5 Prepare the composite sample by taking equal quantity of material from sampled container and it is mixed thoroughly.
5.8.6 Close the raw material container tightly. Transfer the used sampling devices in container labelled as To be cleaned.
5.8.7 Close tightly the sample container and bring the sample to QC department for analysis as per approved specifications under supervision.
5.8.2 Label the sample container with the details.
5.8.3 Mark SAMPLED stamps on container from which the samples are collected. Cross the original approval label of manufacturer on all the
containers.
5.8.4 Affix yellow colour UNDER TEST label on each container below the white label of store with details as per step no. 5.5.2 and sign it.
5.8.5 Prepare sampling record of raw material.

Related: SOP for Retesting Schedule of Raw Material

5.9 Testing and Release

5.9.1 Make entry of the received sample in Raw Material Log Register.
5.9.2 Distribute the sample for chemicals and instrumental analysis as per specifications.
5.9. Issue the photocopy of approved protocols. Perform the analysis as per specifications and test methods and filled all the results in it.
5.9.4 On completion of testing enter the details in the MRR under the heading of Approved /Rejected Quantity.
Date of release or reject
Approved/rejected status
5.9.5 Submit the MRR and testing reports to QC incharge for checking and approval of the material.
6.0 ABBREVIATIONS
6.1 SOP - Standard Operating Procedure

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