1.0 OBJECTIVE

 To lay down the procedure for Sampling, Storage and Destruction of the Reference Samples of Raw Materials, Packing Materials and Drug Products.

2.0        RESPONSIBILITY

  IPQA Executive: Sampling of Reference samples of Drug Products.

2.2        QA   Executive:  Storage and destruction of Reference samples ( drug products).

2.3        QC   Executive:  Storage and destruction of QC Reference Samples (Raw materials and Packing materials).

      3.0      PROCEDURE                  

  • Sampling and Storage of Reference samples of Drug Products:     
  • IPQA Executive is responsible for collection of the Reference sample(s) of drug products during the process of packaging as per the SOP  (sampling of finished products) and submitted to QA executive with stamped as Reference sample
  • For Finished products the sample should be in the same immediate container-closure system in which the products are marketed.
  • Reference samples of drug product shall be stored as per the conditions specified on the label of the container /carton after entering in the Reference Sample Register (Annexure –1).
  • Reference samples of drug products shall be retained for at least one year after the expiry date of the drug product. In the case of products, which do not bear expiry dates, the samples shall be retained for 6 years from the date of manufacture.
  • QA Executive shall visually examine the Reference sample of drug products at least once a year for all commercial batches for evidence of any physical defects / deteriorations, unless visual examination would affect the integrity of the Reference Samples. Record the observations in Reference Sample Visual Inspection Report (Annexure –2).
  • The results of examination shall be recorded and maintained with other stability data.
  • Any evidence of Reference sample deterioration shall be investigated in accordance with failure investigation SOP .
  • If the failure investigation results suggest that products need to be recalled , inform to the Recall coordinator for recall.
  • Destruction of Reference samples of  drug products :
  • Reference Samples of drug products which are to be destroyed, shall be separated and kept in a shipper and labeled as “REFERNCE SAMPLES OF DRUG PRODUCTS FOR DESTRUCTION”.

3.2.2    The Reference samples shall be destroyed after one year of expiry.

3.2.3     Destruction shall be carried out in the presence of IPQA executive.

  • Destruction procedure for Tablets/Capsule/ Dry syrup and Injectables.
  • All finished Capsules, Tablets, Powder for oral suspension, Powder for injection shall be removed from primary pack,  sent to effluent tank.
  • Defoiled primary packs like blisters, strips are cut in to pieces,  and collected in to Polyethylene bag and sent to scrap yard.
  • Emptied primary packs like Vials, Glass bottles, HDPE bottle shall be crossed and  collected in to polyethylene bag and sent to scrap yard.
  • The packing materials like cartons, Labels shall be destroyed by cutting into pieces collected in to polyethylene bag and send to scrap yard.
  • Sampling, Storage of Reference samples of Raw materials and packing materials:

3.4.1        QC Executive / Chemist shall be sampled and labeled the control sample as per respective SOPs (Sampling, Testing and Release of Raw Materials SOP  and Sampling, Testing and Release of Packaging Materials SOP ).

3.4.2        Details of control samples shall be recorded in LIMS for Raw material and Packaging material.

3.4.3        Registration and destruction process of control samples for Raw material and Packaging shall be handled as per LIMS procedure.

  • Control Samples of Raw Materials and packing materials shall be stored under conditions as specified in the respective specifications after entering in LIMS.
  • Control samples of Raw Materials and packing materials shall be retained 5 years from date of receipt the material.

 

  1. ABBREVIATIONS   

 

            4.1       IPQA   –           In-process Quality Assurance

4.2       QA       –           Quality Assurance

4.3       QC       –           Quality Control

4.4        SLS      –            Scientific Laboratory Services

  1. REFERENCES

         

            5.1       Sampling of Finished Products

5.2       Sampling, Testing and Release of Raw Material

5.3      Sampling, Testing and Release of Packing Materials.

ANNEXURES

             6.1       Annexure – 1   Reference Sample Register

6.2       Annexure – 2   Reference Sample Visual Inspection Report.