SOP for Retest of Raw Materials

Objective To provide a written procedure for re-testing of raw materials.

Scope This SOP shall be applicable for Quality Control and Quality Assurance Departments.

Associated Documents:
1 Quality Assurance Report of Materials
2 Sampling Procedure for Raw Materials
3 Handling and Disposition of Non-conforming Raw and Packaging Materials

1 All QC and QA personnel shall be responsible for implementing the procedure.
2 Manager, Quality or his or Designee shall be accountable for training and implementation of the procedure.

Abbreviations and Definitions
Raw Material

Active Ingredients
A substance or compound that is intended to be used in the manufacture of a pharmaceutical product as a pharmacologically active compound (ingredient).

Any ingredient other than the active ingredient added to a pharmaceutical product to permit it to be formed into the proper shape and consistency; the vehicle for the pharmaceutical product.

1 All incoming raw materials when tested and approved for use, shall be assigned a retest date by Manager, Quality.
2 The retest date shall be written in the analytical report sheet of specific raw material.
3 The retest date shall be assigned as follows:
Active Ingredients -Retest after one year
Excipient -Retest after two years

4 If there is a concern for stability of the material, the retest date shall be determined accordingly.
5 In case of re-test date mentioned in COA, material shall be re-tested as per supplier’s recommendation or as per frequency which is earlier and shelf-life can be extended up to a period mentioned in COA.
6 If only re-test date is mentioned in COA, and no shelf-life is available then materials should be re-tested and shelf-life shall be extended initially for one year.
7 For materials with no shelf-life or re-test date, carry out re-test every year and shelf-life can be extended up to 60 months.
8 Re-testing of Raw Materials
8.1 In the last week of every month, Quality Assurance Officer shall check “QA RAW MATERIAL RETEST LOG BOOK” (Enclosure 10.1) and prepare a list of all raw materials to be re-tested one month ahead of due date of re-testing.
8.2 Quality Assurance Officer shall inform Quality Control Officer, who shall plan the sampling in such a way that both the sampling and testing shall be completed within 30 days.
8.3 In case of slow moving item, re-testing date shall be extended and re-testing shall be done before use in production.
8.4 Sampling shall be carried out in used drum as per SOP No. IONQC030.
8.5 During retest, full tests shall not be performed.
8.6 Certain test parameters shall be checked which are as follows:
pH / Acidity / Alkalinity
Loss on Drying / Water Content
Microbial Contamination and
Bacterial Endotoxins

8.7 New assay value on anhydrous/dried basis and water content/LOD shall be incorporated in the system. If the “as is” assay value on re-analysis is found to be higher than the initial “as is” assay value on anhydrous/dried basis, then the initial “as is” assay value shall be reported with reference to new water content/LOD.
8.8 If the retest parameters comply, the Manager, Quality shall approve it. If not, reject the material as per SOP No. IONQA018.
8.9 Manager, Quality then shall release/reject the raw material and issue “Released/Rejected” label and affix the label on individual containers.
8.10 Manager, Quality shall inform Warehouse Officer of the re-approved/rejected material through form no. QA015-01.
8.11 In case of rejection, the material shall be shifted to the assigned “Rejected Area”.
8.12 No material shall be available for use after the retest date, unless it is re-approved.

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