Friday, November 26, 2010

Sampling, Testing and Release of Raw Materials

1.0         Purpose   :      To provide an instruction for sampling, testing and release of raw materials.

2.0      Objective :  To provide a documented procedure for sampling, testing and release of raw materials.

3.0     Scope        :   This procedure is applicable for sampling, testing and release of raw materials in QC
                                department of --- Pharmaceutical Ltd, 

4.0    Responsibility   :
·        Primary       :     QC Chemist / QC Officer
·        Secondary   :     Overall: QC – Incharge

5.0  Procedure:
·      Attire of Sampling Personnel
Ø         The person going for sampling should wear Apron, Cap, Nose Mask, safety goggle & Surgical Gloves.
·      Sampling Accessories
           The following sampling accessories should be used while sampling.
Ø         Spoon, Spatula, Scoop, S.S. Sampling Rod for powders.
Ø         SS Solvent sampler for Liquid Solvents.
Ø         Plastic Bag, Glass bottles etc. for preservation.
·      General Precaution
Ø         The sampling should be done in sampling booth.
Ø         Sampling of solvent received in drums and stored at solvent yard should be done at the place.
Ø      The person going for sampling should be aware of the hazards of material and care to be taken while sampling.
Ø      During sampling care should be taken that there is no cross contamination.
Ø      Use different tools for different material.
Ø      Check that the sampling area is properly cleaned and verify with the sampling area cleaning logbook.
Ø      Sample only one material at a time.
Ø      Check the sampling tool for Cleaned and unclean label.
Ø      Check for the ambiguity of nomenclature on the container.
Ø      Check for damaged container.
Ø      Check for presence of foreign particles.
Ø      If any discrepancies is found report to QA in variation and deficiency form.
Ø      Sample should be collected in appropriate container.
·        Sampling procedure.
Ø      After receipt of intimation / goods received note (GRN) from store department enter the details of the intimation / GRN in the inward register.
Ø      Chemist prepares necessary labels and containers based on raw material intimation / GRN, Raw material specification and sampling plan.
Ø      Take along the sampling accessories for the sampling purpose.
Ø      Sampling chemist inspects all the containers with raw material intimation / GRN
for following:
o      Name of Material
o      Grade ( i.e. I.P., C.P.,Commercial  AR/LR  etc.)
o      Batch No.
o      Manufacturing Date
o      Expiry Date
o      Manufacturing Lic. No.
o      Manufacturers Address
o      Pack Size.
o      Seal Integrity.
o      Damages if any.
Ø      Chemist checks for the quarantine label and its details on all the containers.
Ø      Chemist checks the sampling tools for cleanliness & label for cleaned
Ø      Before start the sampling chemist should start the sampling booth at least 10 minutes before and check pressure on gauge it should be within specified limit. If any deficiency is observed, inform to store / maintenance department.
Ø      Upon conformation of the above requirements, chemist starts the sampling process. He identifies the sampling containers; transfer the containers to sampling booth. He opens the container, checks the inner pack and physical appearance of the material, draws the required quantity of sample from the specified container/pack as per the sampling plan.
Ø      After completion of sampling, seal the container from which sampling is done.
Ø      Affix the SAMPLED Label upon the containers that are sampled, which is duly signed by the sampling person.
Ø      Transfer the entire sampled container to quarantine area from the sampling booth.
Ø      Clean the sampling area properly.
Ø      Clean the sampling tools as per respective standard procedures. Affix the status label on the sampling tools.
·        Testing procedure.
Ø      After completion of sampling, chemist brought the sample to QC department for analysis.
Ø      QC chemist receives the raw material worksheet from QA.
Ø      Chemist refers to the raw material specification and analysis the material.
Ø      Results and calculations are recorded in the worksheets.
Ø      Whenever applicable Chromatogram, graphs, system generated data will be printed from the software and attached to worksheet.
Ø      After completing the analysis, QC chemist prepares Certificate Of Analysis (COA).
Ø      Worksheet and other attachment will be submitted to QC in charge.
Ø      QC in charge will check COA, Worksheet and other attachment.
Ø      If the results are complying, QC chemist completes all the entries in RM Inward register and assign Analytical Report No. (AR No.)
Ø      If the material is found to be not complying QC in charge follows OOS procedure before declaring the material “Rejected”.
Ø      QC in charge must be sign all the three copies of the GRN putting status of material as Approval or Rejected.
Ø      QC chemist prepares “Approved “labels and affix them on all the containers / bags of the material tested.
Ø      The material is then released for use.
Ø      If material is rejected, QC Chemist must be put “Rejected” label on all the containers of the material received.
Ø      After completion of testing, prepared control sample of key raw material and stored it at respective storage area for 5 years.

Log Book For Raw Material



S. No.
Date
Name of Raw material
Material code No.
Mfg. B. No.
Mfg. date
Exp. date








        GRN No.

Manufacturer / Supplier
Qty. received/
No. of containers
Sampled by
Sampled qty.
A.R. No. / Date
Remarks







Format:-F/QC/001
             


Log Book For Raw Material Work Sheet Issuance


S. No.
Name of
Raw material
A.R. No.
Date of issue
Work sheet no.
Given by
Sign
Remarks








Format:-F/QC/004

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