Procedure for Assay Testing of Active Ingredients in Aerosol Products
| Department | Aerosol |
|---|---|
| SOP No. | SOP/Aerosol/191/2025 |
| Supersedes | SOP/Aerosol/191/2022 |
| Page No. | Page 1 of Y |
| Issue Date | 06/02/2025 |
| Effective Date | 16/02/2025 |
| Review Date | 06/02/2028 |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a standardized method for conducting assay testing of active ingredients in aerosol products to ensure potency, consistency, and compliance with regulatory requirements.
2. Scope
This SOP applies to all aerosol formulations containing active pharmaceutical ingredients (APIs) and is applicable in the Quality Control (QC) laboratory.
3. Responsibilities
- Quality Control (QC) Analysts: Responsible for performing the assay tests.
- Quality Assurance (QA) Team: Responsible for reviewing and approving assay test reports.
- Laboratory Supervisor: Responsible for overseeing test procedures and ensuring compliance.
- Production Team: Responsible for providing representative samples for testing.
4. Accountability
The Quality Control Manager is accountable for ensuring assay tests are performed accurately and consistently.
5. Procedure
5.1. Sample Collection
- Collect representative aerosol samples as per the approved sampling plan.
- Label the samples with batch number, date, and analyst details.
- Record sample collection details in the Sample Log (Annexure-1).
5.2. Preparation of Test Solutions
- Weigh a precise amount of the aerosol sample.
- Dissolve the active ingredient in an appropriate solvent.
- Prepare a standard solution for comparison.
- Document preparation details in the Test Preparation Log (Annexure-2).
5.3. Assay Testing
Procedure
- Perform assay testing using a validated analytical method (e.g., HPLC, UV Spectroscopy).
- Run the test in triplicate for accuracy.
- Calculate the concentration of the active ingredient.
- Record assay test results in the Assay Test Log (Annexure-3).
5.4. Data Analysis and Acceptance Criteria
- Compare test results with specified limits (e.g., 95%–105% of label claim).
- Ensure all test values fall within acceptable range.
- Document findings in the Assay Results Report (Annexure-4).
5.5. Handling Out-of-Specification (OOS) Results
- Initiate an investigation if results are out of specification.
- Repeat testing as per standard OOS procedures.
- Record investigation details in the OOS Report (Annexure-5).
6. Abbreviations
- API: Active Pharmaceutical Ingredient
- QC: Quality Control
- QA: Quality Assurance
- HPLC: High-Performance Liquid Chromatography
- UV: Ultraviolet Spectroscopy
- OOS: Out of Specification
7. Documents
- Sample Log (Annexure-1)
- Test Preparation Log (Annexure-2)
- Assay Test Log (Annexure-3)
- Assay Results Report (Annexure-4)
- OOS Report (Annexure-5)
8. References
- Good Manufacturing Practice (GMP) Guidelines
- Pharmacopeial Standards (USP/BP/IP)
- FDA Guidelines on Analytical Method Validation
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 Log
| Batch No. | Sample ID | Collection Date | Analyst |
|---|---|---|---|
| BN-220 | SPL-101 | 07/02/2025 | Rahul Mehta |
Annexure-2: Test Preparation Log
| Sample ID | Solvent Used | Concentration Prepared | Prepared By |
|---|---|---|---|
| SPL-101 | Methanol | 10 mg/mL | QA Team |
Annexure-3: Assay Test Log
| Sample ID | Method Used | Assay Result (%) | Tested By |
|---|---|---|---|
| SPL-101 | HPLC | 99.2% | QA Team |
Annexure-4: Assay Results Report
| Batch No. | Label Claim (%) | Test Result (%) | Approved By |
|---|---|---|---|
| BN-221 | 100% | 99.2% | QA Team |
Annexure-5: OOS Report
| Batch No. | OOS Result | Investigation Status | Reviewed By |
|---|---|---|---|
| BN-222 | 92% | Under Investigation | QA Team |
12. Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | V 1.0 | Initial Release | First Issue | Anjali Sharma |
| 01/01/2025 | V 2.0 | Updated assay procedures | GMP Compliance | Anjali Sharma |