Procedure for Pilot Batch Production of Ointments

Department	Production/Research and Development (R&D)/Quality Assurance
SOP No.	SOP/Ointment/019
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the standardized method for the pilot batch production of ointments. This ensures that the formulation is reproducible, scalable, and meets quality and regulatory requirements before commercial manufacturing.

2. Scope

This SOP applies to the Research and Development (R&D) and Production departments responsible for the preparation, processing, and evaluation of pilot-scale batches of ointments.

3. Responsibilities

• Production Supervisor: Oversees the pilot batch production process.
• Formulation Scientist: Ensures the formulation is prepared as per defined parameters.
• Quality Control (QC) Analyst: Conducts in-process and final quality testing.
• Quality Assurance (QA) Officer: Verifies compliance with GMP standards.
• R&D Head: Reviews and approves pilot batch reports before scale-up.

4. Accountability

The Production and R&D Managers are accountable for ensuring that the pilot batch is produced under controlled conditions and that all records are maintained.

5. Procedure

5.1 Pre-Production Preparation

• Ensure all required raw materials and excipients are available and approved.
• Check the equipment for cleanliness and calibration.
• Review the Master Formula Record (MFR) and ensure all process parameters are defined.
• Assign batch number and document all details in the Pilot Batch Manufacturing Record (BMR).

5.2 Weighing and Dispensing of Ingredients

• Weigh all active pharmaceutical ingredients (APIs) and excipients using a calibrated balance.
• Record the weighed quantities in the Weighing Log.
• Ensure proper labeling and identification of all materials.

5.3 Mixing and Heating Process

• Transfer base components (e.g., waxes, emulsifiers) into the heating vessel.
• Heat to the specified temperature while stirring continuously.
• Add APIs and other excipients under controlled conditions.
• Maintain temperature and mixing speed as per the validated parameters.

5.4 Homogenization and Cooling

• Use a homogenizer to ensure uniform distribution of ingredients.
• Gradually cool the batch to prevent crystallization.
• Monitor viscosity and pH at different cooling stages.

5.5 Sampling and In-Process Quality Control

• Take samples at predefined stages for analysis.
• Perform in-process checks including:
  • pH measurement
  • Viscosity analysis
  • Homogeneity testing
  • Microbial limit testing
• Ensure all test results comply with specified limits.

5.6 Filling and Packaging

• Fill the ointment into appropriate containers using a calibrated filling machine.
• Label and seal containers as per packaging specifications.
• Perform weight variation checks on filled units.

5.7 Final Quality Testing

• Submit finished samples to QC for final analysis.
• Conduct stability testing under accelerated and long-term conditions.
• Compare results with predefined acceptance criteria.

5.8 Documentation and Reporting

• Record all production and testing details in the Pilot Batch Manufacturing Record (BMR).
• Summarize findings in the Pilot Batch Report.
• Obtain approval from the R&D Head and QA before proceeding to commercial scale-up.

6. Abbreviations

• BMR – Batch Manufacturing Record
• MFR – Master Formula Record
• API – Active Pharmaceutical Ingredient
• QC – Quality Control
• QA – Quality Assurance

7. Documents

• Pilot Batch Manufacturing Record (Annexure-1)
• Pilot Batch Report (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• ICH Q1A (R2) Stability Testing Guidelines
• 21 CFR Part 211 – Current Good Manufacturing Practices

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Pilot Batch Manufacturing Record

Date	Batch Number	Process Stage	Observation	Checked By
01/02/2025	SOP/Ointment/001	Weighing	All materials weighed accurately	QA Officer
02/02/2025	SOP/Ointment/002	Homogenization	Uniform distribution achieved	QA Officer

Annexure-2: Pilot Batch Report

Date	Batch Number	Parameter	Specification	Final Result	Final Status
01/02/2025	SOP/Ointment/001	pH	5.5-7.0	6.2	Pass
02/02/2025	SOP/Ointment/002	Viscosity	1000-2000 cP	1500 cP	Pass

12. Revision History:

Revision Date	Revision No.	Details of Revision	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated SOP Format	Standardization of Document	QA Head