Elixir Department: SOP for Compatibility Testing with Containers – V 2.0

Standard Operating Procedure for Compatibility Testing of Elixir Formulations with Containers

Department	Elixir Department
SOP No.	SOP/ELX/227/2025
Supersedes	SOP/ELX/227/2022
Page No.	Page 1 of 8
Issue Date	11/04/2025
Effective Date	15/04/2025
Review Date	11/04/2026

1. Purpose

To establish a procedure for evaluating the compatibility of elixir formulations with their intended packaging materials to ensure product stability, safety, and integrity throughout the shelf-life.

2. Scope

This SOP is applicable to the Quality Control and Product Development Departments for performing compatibility studies on elixir formulations using primary packaging containers such as plastic, glass bottles, closures, and liners.

3. Responsibilities

QC Analyst:
- Conduct compatibility testing as per protocol and record observations.
Formulation Scientist:
- Select packaging components and define test parameters.
QA Officer:
- Ensure test outcomes are within acceptable limits and documented for regulatory submission.

4. Accountability

The Head of QC is accountable for executing compatibility studies. The QA Head is responsible for verifying study compliance with ICH and GMP requirements.

5. Procedure

5.1 Selection of Containers

Use primary containers (glass

or plastic bottles) and closures intended for commercial packaging.

Include alternate packaging if under evaluation.

5.2 Test Design

Fill the selected containers with the elixir formulation (pilot or production batch).
Seal and label the containers with batch number, date, and study code.
Store samples at:
- 25°C ± 2°C / 60% RH ± 5% RH
- 40°C ± 2°C / 75% RH ± 5% RH (accelerated)
- Refrigerated (if applicable)

5.3 Parameters to Evaluate

Visual changes in color, clarity, or precipitation.
pH shift compared to initial value (±0.2 acceptable unless justified).
Leachables or extractables from plastic or rubber components (if required).
Volume loss due to evaporation (NMT 2.0% unless otherwise specified).
Container integrity (cap tightness, cracks, sealing performance).

5.4 Sampling Intervals

Initial (0 month), 1 month, 3 months, and 6 months for accelerated studies.
0, 3, 6, 9, 12, 18, and 24 months for long-term studies (if conducted).

5.5 Acceptance Criteria

No significant changes in color, odor, or appearance.
pH, viscosity, and assay results should remain within ±10% of initial values.
No visible signs of leakage, cap loosening, or deformation.
Compliance with compendial requirements for container-closure systems.

5.6 Documentation

Record all data in the Compatibility Testing Logbook (Annexure-1).
Attach chromatograms, test reports, and deviation notes (if applicable).
Maintain a summary report for submission with regulatory dossiers.

6. Abbreviations

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
ICH: International Council for Harmonisation
RH: Relative Humidity

7. Documents

Compatibility Testing Logbook (Annexure-1)
Container Closure Specification
Batch Manufacturing Record (BMR)

8. References

ICH Q1A(R2) – Stability Testing of New Drug Substances and Products
USP Chapter <661> – Plastic Packaging Systems
21 CFR Part 211.94 – Drug Product Containers and Closures

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Compatibility Testing Logbook

Date	Batch No.	Container Type	Study Condition	Observation	Result	Tested By	Verified By
11/04/2025	ELX-0425-045	Amber PET Bottle	40°C/75% RH	No change in appearance, pH 5.8 (initial 5.9)	Pass	Rajesh Kumar	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	QA Head
11/04/2025	2.0	Added sampling intervals and leachables	Stability Protocol Update	QA Head