1.0 Purpose

To establish a procedure for scheduling and conducting retesting of raw materials after the initial expiry/retest period to ensure continued compliance with specifications before use in manufacturing.

2.0 Scope

This SOP applies to all raw materials stored in the warehouse of [Company Name], including active pharmaceutical ingredients (APIs), excipients, and packaging materials (if applicable), that are subject to retesting as per GMP requirements.

3.0 Responsibility

• Quality Control (QC): Perform testing of raw materials as per retest schedule.

• Quality Assurance (QA): Prepare and review retest schedules, ensure compliance with regulatory requirements, and approve results.

• Warehouse: Provide timely information on stock status and ensure segregation of expired/retest due materials.

4.0 Definitions

• Retest Date: The date up to which a material should be re-examined to ensure it remains suitable for use.

• Retest Period: The duration during which a raw material can be considered suitable for use, provided it passes retesting.

5.0 Procedure

5.1 Preparation of Retesting Schedule

1. On receipt of raw materials, record manufacture date, expiry date, and retest date from the Certificate of Analysis (CoA).

2. Enter these details in the Raw Material Retesting Schedule Register/Software.

3. Generate a Retest Due List monthly for materials approaching their retest date (e.g., within the next 60 days).

4. QA shall review and approve the schedule.

5.2 Identification and Control of Retest Due Materials

1. Materials due for retest shall be quarantined and labeled as “Under Retest”.

2. Warehouse shall ensure such materials are not issued for production until retesting is completed and approved.

3. Segregate expired/rejected materials in a designated area.

5.3 Retesting

1. QC shall collect samples as per SOP on Sampling of Raw Materials.

2. Perform retesting as per the approved specification and test procedures.

3. Record the results in the Analytical Report.

4. If the material meets specifications → release for use and update retest date in the system.

5. If the material does not meet specifications → reject as per SOP on Material Rejection and initiate appropriate action.

5.4 Documentation

1. Maintain Raw Material Retesting Register/Logbook with the following details:

   • Material Name & Code

   • Batch/Lot Number

   • Date of Receipt

   • Retest Due Date

   • Retesting Date

   • QC Results

   • QA Review & Approval

2. Retest data shall be attached with the original CoA and stored in the Material History File.

6.0 Precautions

• Do not use any material beyond its retest date without approved retesting.

• Ensure proper storage conditions as per material specifications (e.g., temperature, humidity).

• If regulatory guidelines specify no retest period (e.g., for certain sterile materials), such materials shall be destroyed after expiry.

7.0 Records

• Retesting Schedule Register/Database

• Retesting Logbook

• QC Analytical Report

• QA Release/Rejection Record

8.0 References

• ICH Q7: Good Manufacturing Practice for Active Pharmaceutical Ingredients

• WHO TRS Guidelines

• EU GMP Part I & Annex 8

• USFDA 21 CFR Part 211

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