Procedure for Preparing a Trial Batch of Ointments

Department	Research and Development (R&D)/Quality Assurance
SOP No.	FD-012
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 define a standardized method for preparing a trial batch of ointments in the Research and Development (R&D) department. This process ensures the reproducibility, stability, and effectiveness of the formulation before scaling up to pilot production.

2. Scope

This SOP applies to the R&D team responsible for preparing and evaluating trial batches of ointments. It covers ingredient weighing, mixing, heating, cooling, and documentation of batch preparation.

3. Responsibilities

• Formulation Scientist: Responsible for the preparation of the trial batch and ensuring adherence to the formulation protocol.
• Analytical Chemist: Conducts testing and analysis on the trial batch.
• Quality Assurance (QA) Personnel: Verifies compliance with formulation and process parameters.
• R&D Head: Reviews and approves trial batch reports before further development.

4. Accountability

The R&D Manager is accountable for ensuring that the trial batch is prepared under controlled conditions and that all results are documented accurately.

5. Procedure

5.1 Pre-Batch Preparations

• Ensure all raw materials are approved and available in the required quantities.
• Verify that all necessary equipment, including weighing balances, mixers, and heating apparatus, are calibrated.
• Prepare a Batch Manufacturing Record (BMR) for the trial batch.

5.2 Weighing of Ingredients

• Weigh all raw materials as per the batch formula using a calibrated balance.
• Record the actual weights in the Trial Batch Weighing Log.
• Ensure all materials are labeled and segregated before processing.

5.3 Mixing and Heating

• Transfer base ingredients (such as emulsifiers and waxes) into a heating vessel.
• Heat the mixture to the specified temperature, ensuring uniform melting.
• Incorporate active pharmaceutical ingredients (APIs) into the heated base while stirring continuously.
• Use a homogenizer if required to ensure uniform dispersion.

5.4 Cooling and Final Mixing

• Gradually cool the batch while stirring at a controlled speed.
• Monitor viscosity and texture changes during cooling.
• Adjust pH, if required, to meet product specifications.
• Perform initial physical inspections, including spreadability and homogeneity tests.

5.5 Sampling and Testing

• Take representative samples for physical and microbiological analysis.
• Conduct pH, viscosity, spreadability, and stability tests.
• Record all test results in the Trial Batch Evaluation Log.

5.6 Documentation and Reporting

• Complete the Batch Manufacturing Record (BMR) with all observations.
• Prepare a Trial Batch Report, including formulation details, test results, and deviations.
• Obtain approval from the R&D Head before proceeding with further optimization or pilot batch production.

6. Abbreviations

• BMR – Batch Manufacturing Record
• API – Active Pharmaceutical Ingredient
• QA – Quality Assurance
• R&D – Research and Development

7. Documents

• Trial Batch Weighing Log (Annexure-1)
• Trial Batch Evaluation Log (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• 21 CFR Part 211 – Current Good Manufacturing Practices
• ICH Q8(R2) Pharmaceutical Development Guidelines

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Trial Batch Weighing Log

Date	Batch Number	Material Name	Weighed Quantity (g)	Weighed By	Verified By
01/02/2025	TB-001	API-A	10.00	John Doe	QA Officer
02/02/2025	TB-002	Emulsifier	5.00	Jane Smith	QA Officer

Annexure-2: Trial Batch Evaluation Log

Date	Batch Number	Test Parameter	Specification	Result	Verified By
01/02/2025	TB-001	Viscosity	1000-2000 cP	1500 cP	QA Officer
02/02/2025	TB-002	pH	5.5-7.0	6.2	QA Officer

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	1.0	Initial Version	New SOP	QA Head	All	All	Created new SOP
01/02/2025	2.0	Updated SOP Format	Standardization of Document	QA Head	All	All	Revised to meet new documentation standards