records comply with all regulatory requirements and that all necessary approvals are documented appropriately.

4. Accountability

The Product Development Manager is accountable for ensuring that this SOP is followed during the batch record documentation process. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparation of Development Batch Records

1. Before starting the development batch, ensure that all necessary documentation forms are available, including:
   • Batch Record Template (Annexure-1)
   • Material Specifications (Annexure-2)
   • In-Process Testing Form (Annexure-3)
   • Final Product Specifications (Annexure-4)
2. Ensure that the batch record contains the following key information:
   • Batch number
   • Formulation details (ingredients, quantities, and specifications)
   • Production date and time
   • List of equipment used (e.g., mixers, filling machines, homogenizers)
   • Environmental conditions (e.g., temperature, humidity, air quality)
   • Details of raw material lot numbers

5.2. Documentation During Batch Production

1. Record all production activities, including the preparation of materials, mixing, filling, and packaging. Include any adjustments or deviations from the standard procedure (e.g., changes in equipment settings or processing conditions).
2. Document the following:
   • Time and date of each step in the manufacturing process
   • Operator details (name and signature)
   • Batch size and yield
   • Raw material lot numbers used in the batch
   • Environmental conditions during manufacturing (e.g., temperature, humidity)
3. Record any deviations from the procedure and describe the actions taken to address the deviations. For example, if a step is missed or a parameter is outside the specified range, document the corrective actions taken.

5.3. In-Process Testing and Documentation

1. During the production process, perform in-process testing as per the approved testing plan. Document the following tests in the batch record:
   • Physical properties (e.g., viscosity, pH, appearance)
   • Performance testing (e.g., spray pattern, droplet size, actuation testing)
   • Weight or volume measurements
   • Microbial testing (if applicable)
2. Record all test results in the In-Process Testing Form (Annexure-3), including the date, test method, results, and tester’s name and signature.
3. If the test results are within specifications, continue with the process. If the test results are out of specification (OOS), follow the OOS procedure and document the corrective actions taken.

5.4. Final Product Testing and Documentation

1. After the batch is completed, perform final product testing to verify that the product meets the required specifications. The testing may include:
   • Active ingredient content
   • Propellant content (for aerosol products)
   • Leakage and integrity testing
   • Stability tests (if applicable)
2. Record the final test results in the Final Product Specifications form (Annexure-4), including the test method, results, and approval signatures.
3. Ensure that the batch meets all specifications before it is released for further processing or stability testing.

5.5. Review and Approval of Development Batch Records

1. After the batch production and testing are completed, the development batch record must be reviewed by the Formulation Development and Quality Control teams to ensure all required information is documented accurately.
2. The reviewed batch record should be approved by the following personnel:
   • Formulation Development Team Lead
   • Quality Control Supervisor
   • Regulatory Affairs Team (if necessary)
3. Ensure that the final batch record is signed, dated, and filed in the appropriate documentation storage system for traceability and compliance with regulatory requirements.

5.6. Retention and Storage of Batch Records

1. Ensure that all batch records are stored in a secure, easily accessible location according to the company’s document retention policy. The records must be retained for the required period as per regulatory requirements and internal policies.
2. Ensure that electronic batch records, if used, are backed up and stored in compliance with data integrity standards.
3. Batch records should be available for review during audits or inspections by regulatory authorities.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• CAPA: Corrective and Preventive Actions
• R&D: Research and Development

7. Documents

1. Batch Record Template (Annexure-1)
2. Material Specifications (Annexure-2)
3. In-Process Testing Form (Annexure-3)
4. Final Product Specifications (Annexure-4)
5. CAPA Log (Annexure-5)

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 9001:2015 – Quality Management Systems
• International Conference on Harmonization (ICH) Q7A – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

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 Record Template

Batch No.	Formulation	Raw Materials Used	Batch Size	Production Date
12345	Example Aerosol	Propellant A, Excipients X, Y	1000 cans	06/02/2025

Annexure-2: Material Specifications

Material Name	Specification	Lot Number	Supplier
Propellant A	Purity: 99%	1234AB	Supplier X

Annexure-3: In-Process Testing Form

Test Parameter	Test Date	Test Result	Tested By
Viscosity	06/02/2025	Pass	Rajesh Patel

Annexure-4: Final Product Specifications

Test Parameter	Specification	Test Result	Tested By
Spray Pattern	Uniform	Pass	Rajesh Patel

Annexure-5: CAPA Log

Issue	Root Cause	Corrective Action	Preventive Action	Follow-up Date
Incorrect labeling	Human error	Training session conducted	Improved labeling verification	06/03/2025

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 record documentation procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures