ANALYSIS AT PUBLIC LABORATORY

1.0. PURPOSE:
To give a detailed procedure to send samples for analysis at approved public laboratories.
2.0.SCOPE: :
This covers Raw Materials, Intermediates, Finished Products, Stability Studies and Customer Complaint Samples, Out of Calibration Period Samples.
3.0.RESPONSIBILITIES:
Executive-Quality Control
4.0. ACCOUNTABILITY:
Manager-Quality Control
5.0. DEFINITION:
Approved Laboratory: Approved by Drugs Control Department of State Government for testing and analysis.
6.0. PROCEDURE:
6.1. Although our QC laboratory is well equipped with modern equipment like HPLC, GC, and FTIR some specific test can not be carried out at our end.
6.2. Those difficult analyses has to be identified. (Annexure I)
6.3. Those tests to be minimum in number.
6.4. Tests, which cannot be carried out at our end, should only be asked from outside approved laboratories.
6.5. The remaining all possible tests should be carried out In-house.
6.6. Prior approval should be taken from Senior Quality Control Manager.
6.7. The samples should accompany with a Test request form. (Anexure II)
6.8. On receipt of result from approved laboratory, the test result to be checked and signed by Asst. Quality Control Manager.
6.9. Any complaint samples received from market or customer also can be sent to public laboratory for parallel analysis. This is to confirm in-house results.
6.10. Samples can be sent to public laboratories if any In-house instrument goes out of calibration. This is for the particular test involving out of calibration instrument.
6.11. Samples can be sent to analysis mainly finished products for methodology development as part of ruggedness (intra laboratory analysis)
6.12. Samples also can be sent to public laboratory, which require certain impurities / reference standards for analysis. This is specific to materials for which In-house do not have reference standards / impurity.
6.13. Those samples, which require only qualitative tests, can be sent for three batches continuously for validation. Based on the validation results, further consignment of raw material can be approved.
6.14. Once it is validated samples can also be sent for analysis, once in 10th batch, provided there is no change in approved vendor.
6.15. In case of Trade products First six batch of all products shall be sent for Out side public laboratory for analysis.
6.16. If there is no discrepancy, the bill can be approved and recommended for payment through RR from stores.
7.0. REFERENCES:
Nil
8.0. ENCLOSURES:
Annexure for Approved Laboratories & Testing to be performed outside
9.0. ABBREVIATIONS:
Nil