SOP for Preparing Batch Manufacturing Records for Aerosol Products
| Department | Aerosol |
|---|---|
| SOP No. | SOP/Aerosol/151/2025 |
| Supersedes | SOP/Aerosol/151/2022 |
| 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 define the process for preparing batch manufacturing records (BMR) for aerosol products. BMRs are critical for documenting the manufacturing process and ensuring that each batch of aerosol products is produced in compliance with regulatory standards, Good Manufacturing Practices (GMP), and company policies. This SOP outlines the steps involved in creating, reviewing, and maintaining accurate and complete BMRs for aerosol products.
2. Scope
This SOP applies to the preparation of batch manufacturing records for all aerosol products produced in the manufacturing facility. It covers the process from initial batch record creation to final review and approval, including the documentation of manufacturing steps, materials used, and test results.
3. Responsibilities
- Production Team: Responsible for preparing the batch manufacturing record during the production process. They ensure that all required information is documented accurately, including materials used, quantities, equipment used, and any deviations encountered during production.
- Quality Assurance (QA) Team: Responsible for reviewing the batch manufacturing record to ensure completeness, accuracy, and compliance with GMP and regulatory standards. The QA team also ensures that any deviations are properly documented and corrective actions are taken as needed.
- Engineering Team: Responsible for ensuring that any equipment used in the production process is functioning correctly and is properly documented in the batch manufacturing record.
- Warehouse Team: Responsible for ensuring that materials used in the batch are accurately tracked and documented in the BMR, and that the correct materials are available and used in the production process.
4. Accountability
The Manufacturing Manager is accountable for ensuring that batch manufacturing records are prepared and maintained according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.
5. Procedure
5.1. Preparing the Batch Manufacturing Record
- Prior to the start of the manufacturing process, prepare a batch manufacturing record for the specific aerosol product to be produced. The BMR should include the following information:
- Batch number
- Product name and code
- Manufacturing date and time
- List of raw materials used, including their batch numbers and quantities
- Equipment used (e.g., mixers, filling machines, etc.)
- Production personnel involved in the process
- Any relevant quality control or testing procedures to be performed
- Ensure that the batch manufacturing record is aligned with the approved master batch record for the product, which includes the detailed manufacturing process steps and controls.
- During the production process, ensure that all required data is entered into the batch manufacturing record. This includes:
- Raw material lot numbers and quantities used
- Equipment calibration and usage logs
- Process parameters (e.g., temperature, pressure, mixing time) and any deviations observed
- In-process testing results (e.g., weight checks, fill volume tests, etc.)
- Any adjustments or deviations from the standard process and corrective actions taken
5.2. Documenting Deviation and Corrective Action
- If any deviations from the standard process are encountered during production, they must be documented in the deviation section of the batch manufacturing record. The following information should be included:
- A description of the deviation
- The cause of the deviation (if known)
- The corrective actions taken to address the deviation
- Any impact on the final product or process
- Approval of the corrective actions by the QA team
- Ensure that any corrective actions taken are documented in the Corrective Action Log (Annexure-2) and that any necessary investigations are conducted to determine the root cause of the deviation.
5.3. Finalizing and Reviewing the Batch Manufacturing Record
- Once the production process is complete, finalize the batch manufacturing record. Ensure that all sections of the BMR are filled out correctly, and that all required signatures are obtained, including signatures from production personnel, QA personnel, and any other relevant team members.
- The QA team should perform a thorough review of the batch manufacturing record to ensure that it is complete, accurate, and in compliance with regulatory and GMP requirements. The review should include checking the following:
- Completeness of the record
- Accuracy of the data entered
- Appropriate documentation of deviations and corrective actions
- Verification of in-process test results
- Once the QA team completes the review, the batch manufacturing record should be approved and signed off by the QA team. Any unresolved issues or deviations should be addressed before approval.
5.4. Archiving the Batch Manufacturing Record
- Once the batch manufacturing record has been finalized and approved, it should be stored in a secure and organized manner for future reference, audits, or regulatory inspections.
- Ensure that all batch manufacturing records are retained for the required duration according to company policy and regulatory requirements.
- Make sure that batch records are accessible to authorized personnel when needed for audits, investigations, or inspections.
6. Abbreviations
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- SOP: Standard Operating Procedure
- CAPA: Corrective and Preventive Action
- BMR: Batch Manufacturing Record
- QC: Quality Control
7. Documents
- Batch Manufacturing Record (Annexure-1)
- Deviation Log (Annexure-2)
- Corrective Action Log (Annexure-3)
8. References
This SOP is based on the following regulatory guidelines and industry standards:
- Good Manufacturing Practice (GMP) Guidelines
- FDA Code of Federal Regulations (CFR) Title 21, Part 211
- ISO 9001 – Quality Management Systems
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Batch Manufacturing Record
| Batch Number | Product Name | Manufacturing Date | Raw Materials Used | Equipment Used | Test Results | Deviation |
|---|---|---|---|---|---|---|
| BN-12345 | Aerosol Spray | 06/02/2025 | Water-001, Gas-002 | Filling Machine-01 | Pass | N/A |
Annexure-2: Deviation Log
| Deviation ID | Deviation Description | Corrective Action | Assigned To | Status |
|---|---|---|---|---|
| DEV-12345 | Pressure deviation during filling | Adjusted pressure settings | Rajesh Patel | Completed |
Annexure-3: Corrective Action Log
| Action ID | Action Description | Responsible Person | Completion Date |
|---|---|---|---|
| CA-12345 | Recalibrated filling machine pressure | Rajesh Patel | 06/02/2025 |
12. Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By | Page No. | Ref. Point No. | Details of Revision |
|---|---|---|---|---|---|---|---|
| 01/01/2024 | V 1.0 | Initial Release | First Issue | Anjali Sharma | Page 1 | [Ref Point] | First Release |
| 01/01/2025 | V 2.0 | Updated batch manufacturing record format | To comply with updated GMP regulations | Anjali Sharma | Page 1 | [Ref Point] | Updated procedures |