Standard Operating Procedure for Assay of Active Ingredient in Aerosols
1) Purpose
The purpose of this SOP is to establish procedures for the assay of active pharmaceutical ingredients (APIs) in aerosol formulations. Assay testing ensures accurate determination of API content to meet regulatory requirements and product specifications.
2) Scope
This SOP applies to the assay testing activities performed at [Company Name] for aerosol products, including in-process and release testing of batches.
3) Responsibilities
Quality Control (QC) Analysts: Responsible for performing assay testing.
Formulation Scientists: Provide test samples and collaborate on testing protocols.
Quality Assurance (QA) Manager: Ensure compliance with testing procedures and documentation.
4) Procedure
4.1 Sample Preparation:
4.1.1 Obtain representative samples from the aerosol batch as per sampling plan.
4.1.2 Prepare samples according to specified procedures to ensure uniformity and integrity.
4.2 Assay Method:
4.2.1 Select appropriate assay method (e.g., HPLC, UV spectrophotometry) based on API properties and formulation matrix.
4.2.2 Validate assay method if not previously validated, ensuring specificity, accuracy, precision, linearity, and robustness.
4.3 Testing Protocol:
4.3.1 Perform assay testing according to validated method protocols.
4.3.2 Analyze samples in triplicate or as per method requirements to ensure reliable results.
4.4 Data Analysis:
4.4.1 Calculate API concentration in samples based on assay method results.
4.4.2 Compare assay results against acceptance criteria or specifications to determine batch compliance.
4.5 Reporting:
4.5.1 Document testing procedures, results, and any deviations encountered during testing.
4.5.2 Prepare assay testing reports and ensure timely review and approval by authorized personnel.
4.6 Recordkeeping:
4.6.1 Maintain accurate records of assay testing activities, including raw data, calculations, and final reports.
4.6.2 Archive testing records in accordance with document retention policies and regulatory requirements.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
API: Active Pharmaceutical Ingredient
HPLC: High-Performance Liquid Chromatography
UV: Ultraviolet
6) Documents, if any
Assay Method Validation Reports
Assay Testing Reports
Batch Documentation
7) Reference, if any
GMP Guidelines
Pharmacopeial standards (e.g., USP, EP)
8) SOP Version
Version 1.0
