Standard Operating Procedure for Sample Retention Procedure in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/239/2025 |
| Supersedes | SOP/ELX/239/2022 |
| Page No. | Page 1 of 7 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To establish a procedure for the retention of reference and stability samples of elixir formulations to support batch investigation, regulatory compliance, and quality monitoring throughout the product’s shelf-life.
2. Scope
This SOP applies to the Quality Control and Quality Assurance departments for the retention of raw materials, in-process materials, and finished product samples from commercial and development batches of elixirs.
3. Responsibilities
- QC Analyst:
- Collect and label samples as per the retention matrix.
- Maintain storage conditions as defined in the SOP.
- QA Officer:
- Ensure traceability, documentation, and inspection of retained samples.
- Warehouse Personnel:
- Assist in allocation and identification of retained sample locations.
4. Accountability
The QA Head is accountable for ensuring compliance with retention requirements as per GMP and regulatory guidelines.
5. Procedure
5.1 Sample Types
- Retention Sample: A representative sample of the batch stored for
future reference.
Stability Sample: A sample placed on an ongoing stability program as per ICH guidelines.
5.2 Sample Quantity
- Retention sample: Sufficient quantity to perform complete retesting.
- Minimum of two commercial containers per batch (e.g., 2 × 100 mL bottles).
- Stability sample: As defined in the approved stability protocol.
5.3 Sampling and Labeling
- Label must include:
- Product name
- Batch number
- Manufacturing date
- Expiry date
- Sample type (Retention/Stability)
- Samples must be taken after final QC approval of the batch.
5.4 Storage Conditions
- Store retention samples under labeled storage conditions (usually room temperature: 25°C ± 2°C / 60% RH ± 5%).
- Stability samples to be stored in validated chambers as per protocol.
- Ensure segregation of batches to avoid mix-ups.
5.5 Retention Duration
- One year after expiry date or one year after batch release (whichever is longer).
- Raw material retention as per respective SOP or minimum of 2 years from receipt date.
5.6 Disposal of Samples
- After the retention period, samples shall be destroyed following QA approval.
- Maintain disposal records with date, batch number, and disposal method.
5.7 Documentation
- Record all samples in the Retained Sample Register (Annexure-1).
- Include storage location, shelf details, and inspection status.
- Update records during periodic audits or visual inspections.
6. Abbreviations
- SOP: Standard Operating Procedure
- QC: Quality Control
- QA: Quality Assurance
- RH: Relative Humidity
- ICH: International Council for Harmonisation
7. Documents
- Retained Sample Register (Annexure-1)
- Stability Protocol
- Sample Disposal Log
8. References
- 21 CFR Part 211.170 – Reserve Samples
- ICH Q1A(R2) – Stability Testing of New Drug Substances and Products
- WHO GMP Guidelines for Pharmaceuticals
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Retained Sample Register
| Date | Product Name | Batch No. | Sample Type | Storage Condition | Location | Checked By |
|---|---|---|---|---|---|---|
| 11/04/2025 | Iron Elixir | ELX-0425-055 | Retention | 25°C / 60% RH | Shelf B3 | Sunita Reddy |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | New SOP Creation | QA Head |
| 11/04/2025 | 2.0 | Aligned with WHO GMP & added stability retention | Regulatory Compliance | QA Head |