Standard Operating Procedure for In-process Testing for Aerosols
1) Purpose
The purpose of this SOP is to define procedures for conducting in-process testing during aerosol production in the pharmaceutical industry. In-process testing ensures that critical quality attributes are monitored and controlled throughout the manufacturing process.
2) Scope
This SOP applies to all stages of aerosol production at [Company Name], including formulation, filling, and packaging processes where in-process testing is necessary to verify product quality and compliance.
3) Responsibilities
Quality Control (QC) Analysts: Perform in-process testing according to defined procedures.
Production Operators: Collect samples and assist in in-process testing activities.
Quality Assurance (QA) Manager: Oversees compliance with in-process testing procedures and documentation.
4) Procedure
4.1 Sampling:
4.1.1 Collect representative samples at specified intervals during production according to sampling plan.
4.1.2 Ensure samples are collected using validated sampling techniques to maintain sample integrity.
4.2 Testing Procedures:
4.2.1 Perform in-process tests as per approved test methods and specifications.
4.2.2 Include tests for critical parameters such as pH, viscosity, fill weight, and propellant content.
4.3 Recordkeeping:
4.3.1 Record test results accurately and promptly in designated logbooks or electronic records.
4.3.2 Document any deviations or out-of-specification results and initiate investigation and corrective actions as needed.
4.4 Compliance Verification:
4.4.1 Verify compliance of in-process parameters with established acceptance criteria.
4.4.2 Review and approve in-process testing records for completeness and accuracy.
4.5 Equipment Calibration:
4.5.1 Ensure that testing equipment used for in-process testing is calibrated and maintained.
4.5.2 Perform routine calibration checks and document results as per calibration SOPs.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
In-process Testing Records
Calibration Certificates
Deviation and Corrective Action Reports
7) Reference, if any
GMP Guidelines
Pharmacopeial standards (e.g., USP, EP)
8) SOP Version
Version 1.0
