Learn SOP for retesting of packaging materials with SAP workflow, testing criteria & compliance tips.
Introduction
In pharmaceutical manufacturing, packaging materials directly impact product safety, stability, and compliance. Over time, even approved materials can degrade or fail specifications—making periodic retesting essential.
This SOP outlines a systematic, GMP-compliant procedure for scheduling and performing retesting of primary packaging materials using SAP, ensuring quality, traceability, and regulatory compliance.
1.0 OBJECTIVE
To ensure compliance with specifications for approved primary packaging materials at regular intervals during storage.
2.0 SCOPE
This SOP applies to all approved primary packaging materials stored in the packaging material warehouse.
3.0 RESPONSIBILITY
3.1 Doing
- Technical Assistant / Executive
3.2 Checking
- Executive / Manager
4.0 ACCOUNTABILITY
- Head of the Department
5.0 PROCEDURE
5.1 Overview of Retesting Process
The retesting process ensures that stored packaging materials remain compliant with defined specifications through:
- SAP-based scheduling
- Controlled sampling
- Standardized testing
- Status updates and labeling
5.2 Step-by-Step SOP
How to Schedule Retesting of Packaging Material
- Generate a retesting list in SAP using QA33 (Inspection Lot Origin 09).
- Change material status from Unrestricted → Quality Inspection.
- Sample materials as per the generated list.
- Verify inspection lot origin against records.
- Label materials as “UNDER RETEST”.
- Perform testing as per defined specifications.
- Record results and prepare retest report in SAP.
- Update material status (Accepted/Rejected/etc.).
- Maintain retesting records.
- Relabel materials based on final status.
5.3 SAP-Based Retesting Workflow
- Use SAP transaction QA33
- Filter by Inspection Lot Origin: 09
- Generate retesting schedule (Annexure-I reference)
- Ensure real-time status updates in SAP
5.4 Material Status Change
- Initial Status: Unrestricted Stock
- During Retesting: Quality Inspection Stock
- Post Testing:
- Accepted
- Rejected
- Partially Rejected
- Failed
5.5 Sampling & Verification
- Sample as per SAP-generated list
- Cross-check:
- Material name
- Analytical Report Number (A.R. No.)
- Inspection origin
5.6 Labeling Requirements
Under Retest Label (Blue Color)
Each box/roll must include:
- Name of Material
- A.R. No.
- Sampled By
- Date
⚠️ Cross out previous “Approved” label clearly.
5.7 Testing Requirements for Packaging Materials
| Sr. No. | Packaging Material | Tests Performed |
|---|---|---|
| 01 | Aluminium Foils | Description, pinholes, size, thickness |
| 02 | Vials & Ampoules | Description, chemical resistance |
| 03 | Plastic Caps | Description, loss on drying |
| 04 | PVC/PVDC Foil | Description, size, thickness |
| 05 | Rubber Stopper | pH, biological test |
| 06 | Silica Bag | Description, loss on drying |
👉 Note: Physical description must be checked for all materials.
5.8 Retest Report & Documentation
- Prepare retest report
- Record results in SAP
- Obtain approval from QC Incharge
- Maintain records in a dedicated file
5.9 Final Labeling After Testing
- ✅ Approved: Affix “APPROVED” label with new retest date
- ❌ Rejected: Affix “REJECTED” label
5.10 Retesting Schedule (Annexure-I)
| Sr. No. | Material | Retesting Period |
|---|---|---|
| 01 | Plain Foil | 1 Year |
| 02 | Printed Foil | 1 Year |
| 03 | PVC Film | 1 Year |
| 04 | PVDC Film | 1 Year |
| 05 | Vials | 1 Year |
| 06 | Ampoules | 1 Year |
| 07 | Plastic Caps | 6 Months |
| 08 | Rubber Stopper | 1 Year |
| 09 | Silica Bag | 6 Months |
6.0 ABBREVIATIONS
| Abbreviation | Meaning |
|---|---|
| SOP | Standard Operating Procedure |
| PVC | Polyvinyl Chloride |
| PVDC | Polyvinylidene Chloride |
| A.R. No. | Analytical Report Number |
Safety & Compliance Tips
- Always follow GMP guidelines during sampling and testing
- Ensure proper labeling to avoid mix-ups
- Maintain clean and contamination-free sampling areas
- Use calibrated instruments for testing
- Document every step for audit readiness
Common Mistakes to Avoid
- ❌ Missing retesting deadlines
- ❌ Incorrect SAP inspection lot selection
- ❌ Improper labeling or missing details
- ❌ Skipping physical inspection
- ❌ Not updating SAP status after testing
Best Practices
- Automate retesting reminders in SAP
- Maintain a centralized retesting log
- Train staff regularly on SOP compliance
- Conduct internal audits for process verification
- Use color-coded labels for clarity
FAQs
1. What is packaging material retesting?
It is periodic testing of stored packaging materials to ensure compliance with specifications.
2. Why is retesting required in pharma?
To ensure material integrity, safety, and regulatory compliance.
3. What is SAP QA33 used for?
It is used to generate inspection lots for retesting.
4. What is Inspection Lot Origin 09?
It indicates retesting or recurring inspection in SAP.
5. How often should packaging materials be retested?
Typically every 6 months to 1 year depending on material type.
6. What happens if material fails retesting?
It is rejected and labeled accordingly.
7. Who approves the retesting results?
Quality Control Incharge.
8. Why is labeling important during retesting?
To avoid mix-ups and ensure traceability.
9. Can approved material become rejected later?
Yes, due to degradation during storage.
10. What records must be maintained?
Retesting reports, SAP entries, and inspection logs.