Retest of Raw Materials SOP

Retest of Raw Materials SOP

1.0   PURPOSE:

1.1.            To establish a procedure to ensure Quality/Specifications of the Materials.

2.0    SCOPE:

2.1.      This procedure applies to all starting materials (API & Excipients) which are not used/consumed before the re-test due date.

3.0   RESPONSIBILITY:

3.1.      Inventory Control Manager

3.2.      Store Pharmacist

3.3.      Quality Control Manager

3.4.      Quality Assurance Manager

4.0    PROCEDURE:

4.1.      Store Person checks the materials (API) for expiry date.

4.2.      Remove the materials (for which Re-test date is due), from released area and shift it to Quarantine at least 15 days before due retest date.

4.3.      Label the material as “QUARANTINE”.

4.4.      Intimate QA for sampling of materials through sampling intimation

4.5.      Material sampling will be done as per SOP-07-003.

4.6.      Affix “SAMPLED” label.

4.7.      When material is released by QC, Re-locate the material to respective released area and label it as “RELEASED”.

4.8.      If material is rejected then shift it to Reject Area and label it as “REJECTED” and dispose it as per relevant SOP.

5.0    NOTE:

5.         NOTE: The material (API) is only to retest when retest date is mentioned on CoA of the material (API). If only the expiry date is mentioned then material will be Rejected on the basis of expiry date, retesting will not be done for it.

6.0      RISK ANALYSIS:

EVIDENCES OF RECORDS & REFERENCES			QC Reports.
FORMAL KPIs (Key Performance Indicators)			Proper labeling of the materials in Raw Materials Store
GENERAL RISKS			CONTROL   MEASURES		CUSTODIAN
Risks	Impact
Materials are not being checked before expiry	Dispensing of expired materials for batch manufacturing	Ensure retesting of materials for which retest is required as per COA of the material.		Store Pharmacist