Standard Operating Procedure for Batch Manufacturing Record for Aerosols
1) Purpose
The purpose of this SOP is to establish guidelines for documenting and controlling the manufacturing process of aerosol batches. A Batch Manufacturing Record (BMR) ensures consistency, traceability, and compliance with regulatory requirements throughout production.
2) Scope
This SOP applies to the preparation, completion, and review of BMRs for aerosol batches manufactured at [Company Name]. It covers all stages of production from raw material handling to finished product packaging.
3) Responsibilities
Production Supervisor: Responsible for overseeing batch manufacturing activities.
Quality Assurance (QA) Personnel: Review and approve BMRs for compliance.
Quality Control (QC) Analysts: Monitor critical process parameters and perform in-process testing.
Documentation Specialist: Maintain BMRs and ensure accuracy and completeness.
4) Procedure
4.1 Preparation Before Manufacturing:
4.1.1 Review and verify formulation and processing instructions against approved master production records (MPRs).
4.1.2 Ensure availability and readiness of raw materials, equipment, and personnel.
4.2 Recording Manufacturing Steps:
4.2.1 Document the start time, batch number, and personnel involved in each manufacturing step.
4.2.2 Record all critical process parameters, including temperature, pressure, mixing times, and any deviations encountered.
4.3 Sampling and In-process Testing:
4.3.1 Collect samples at specified intervals during manufacturing for in-process testing.
4.3.2 Perform tests (e.g., fill weight, propellant content, pH) according to approved testing procedures.
4.4 Deviation Handling:
4.4.1 Document and investigate any deviations from standard operating procedures or unexpected events.
4.4.2 Implement corrective actions as necessary and obtain approval before continuing production.
4.5 Final Product Verification:
4.5.1 Verify completion of all manufacturing steps and compliance with specifications.
4.5.2 Perform final product checks, including appearance, labeling, and packaging integrity.
4.6 Completion and Review:
4.6.1 Complete the BMR with all required signatures and approvals.
4.6.2 Review BMR for accuracy, completeness, and compliance with regulatory requirements before release.
4.7 Documentation and Archiving:
4.7.1 Maintain BMRs in a secure and controlled manner.
4.7.2 Archive BMRs according to document retention policies and regulatory guidelines.
5) Abbreviations, if any
SOP: Standard Operating Procedure
BMR: Batch Manufacturing Record
MPR: Master Production Record
QC: Quality Control
6) Documents, if any
Master Production Records (MPRs)
In-process Testing Procedures
Deviation Investigation Reports
7) Reference, if any
GMP Guidelines
Pharmacopeial standards (e.g., USP, EP)
Regulatory Requirements (e.g., FDA, EMA)
8) SOP Version
Version 1.0
