Elixir Department: SOP for Destructive vs. Non-Destructive Testing – V 2.0

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