SOP For Retesting of Primary Packaging Material (PPM)

SOP For Retesting of Primary Packaging Material (PPM)

1.0 Objective

1.1 To lay down the procedure for retesting of Primary Packaging Materials (PPM) to ensure their continued suitability and compliance with approved specifications before use.

2.0 Scope

2.1 This SOP is applicable to the retesting of Primary Packaging Materials in the Quality Control (QC) Department.

3.0 Responsibility

3.1 Chemist or above – Quality Control Department

• Responsible for performing sampling, testing, and documentation of retesting of primary packaging materials.

3.2 Officer or above – Warehouse Department

• Responsible for initiating and submitting the retesting request for primary packaging materials.

4.0 Accountability

4.1 Head – Quality Control

• Accountable for ensuring proper implementation of the retesting procedure and review of results.

4.2 Head – Warehouse

• Accountable for timely identification and submission of materials due for retesting.

4.3 Head – Quality Assurance

• Responsible for overall compliance with this SOP and regulatory requirements.

5.0 Procedure

5.1 Approved Primary Packaging Materials that have reached their retesting period shall be re-evaluated to determine their suitability for further use, particularly when materials have been stored for extended periods or under conditions that may adversely affect their quality.

5.2 The initial retesting period shall be calculated from the date of initial approval, and subsequent retesting intervals shall be determined based on the previous retest approval date.

5.3 Retesting may also be conducted as directed by the Quality Assurance Department, based on necessity, deviation, or risk assessment.

5.4 Refer to Annexure II – Packaging Material Retesting Schedule for the predefined retest periods of packaging materials.

5.5 The Warehouse Department shall prepare and provide a list of materials due for retesting in advance and submit a Reanalysis Request Form for each material as per SOP.

5.6 Upon receipt of the request, the QC personnel shall record the details in the “Retesting Packaging Material Control Register” (Annexure-I) and allocate an Analytical Request (A.R.) Number and worksheet.

5.7 The A.R. Number for retesting shall be generated by adding the suffix “/Rn” to the existing A.R. Number, where:

• “/” = Separator

• “R” = Retesting

• “n” = Number of times the material has undergone retesting

5.8 QC personnel shall perform sampling of materials under retesting in accordance with SOP and ensure that a Quarantine Label is affixed on each container.

5.9 QC personnel shall ensure that all existing labels on each container (including Quarantine, Sampled, and Approval Labels) are marked with a cross (X) and replaced with a Sampled Label.

5.10 Analysis shall be performed according to the respective Packaging Material Specification and applicable General Test Procedures (GTP/STP). If specific tests are not mentioned for retesting, complete testing shall be performed as per the approved specification and STP/GTP.

5.11 Testing results shall be evaluated and the material shall be approved or rejected as per SOP.

5.12 After completion of testing, QC personnel shall record the release or rejection status in Annexure.

5.13 Appropriate status labels shall be affixed on the containers in such a way that the existing Quarantine Label is completely overlapped.

---

6.0 List of Annexures