Standard Operating Procedure for Destructive and Non-Destructive Testing of Elixir Products
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/240/2025 |
| Supersedes | SOP/ELX/240/2022 |
| 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 standardized procedure for distinguishing and conducting destructive and non-destructive tests on elixir formulations during in-process, finished product, and stability testing phases.
2. Scope
This SOP applies to the Quality Control Department and applies to all batches of elixirs where physical, chemical, or microbiological evaluations require either destructive or non-destructive approaches.
3. Responsibilities
- QC Analyst:
- Perform assigned tests based on defined method classification (destructive/non-destructive).
- QC Supervisor:
- Review test plans and ensure sample integrity based on test classification.
- QA Officer:
- Review test execution strategy and approve method suitability.
4. Accountability
The QC Head is accountable for implementation and adherence to this SOP. The QA Head is responsible for ensuring that sample classification aligns with regulatory expectations and internal policies.
5. Procedure
5.1 Definitions
- Destructive Testing: Testing in which the sample is altered, destroyed,
or rendered unusable post-evaluation.
Non-Destructive Testing: Testing in which the sample remains intact and suitable for retention or further use.
5.2 Examples of Destructive Testing
- Assay of active ingredients by HPLC
- Preservative content and alcohol content tests
- Microbial limit testing
- pH testing requiring container opening
5.3 Examples of Non-Destructive Testing
- Visual inspection for clarity, color, and particulate matter
- Container integrity testing (e.g., vacuum leak detection, torque testing)
- Labeling, packaging, and fill volume inspection (external only)
5.4 Sample Management
- Segregate samples for destructive vs. non-destructive tests before initiating testing.
- Label containers appropriately with “Destructive” or “Non-Destructive”.
- Record the batch number, container number, and purpose of test in the Sample Management Log (Annexure-1).
5.5 Testing and Reporting
- Conduct tests as per the validated methods and document findings.
- Destructive test samples must not be returned to inventory or reused.
- Non-destructive test samples must be retained and handled per SOP for retained samples, if required.
- Record results separately for each test type in respective data sheets or LIMS systems.
5.6 Disposal of Destructive Samples
- Destroy samples post-testing in accordance with waste disposal SOP.
- Document disposal details in the Sample Disposal Log with QA review.
5.7 Auditing and Review
- QA shall review classification of test types periodically.
- Any reclassification of a method must be updated in the master method list.
6. Abbreviations
- SOP: Standard Operating Procedure
- QC: Quality Control
- QA: Quality Assurance
- LIMS: Laboratory Information Management System
7. Documents
- Sample Management Log (Annexure-1)
- Sample Disposal Log
- Master Test Method List
8. References
- ICH Q6A – Specifications: Test Procedures and Acceptance Criteria
- WHO Technical Report Series 996 – Annex 2
- 21 CFR Part 211 – Subpart I: Laboratory Controls
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Sample Management Log
| Date | Batch No. | Container ID | Test Type | Analyst | Disposition |
|---|---|---|---|---|---|
| 11/04/2025 | ELX-0425-056 | CN-015 | Destructive | Rajesh Kumar | Disposed after assay |
| 11/04/2025 | ELX-0425-056 | CN-016 | Non-Destructive | Sunita Reddy | Retained in stability chamber |
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 | Clarified classification and added control checks | Regulatory Compliance | QA Head |