formulation development, documentation, and approval of master formula records for injectable dosage forms in the sterile injectable manufacturing facility.

3. Responsibilities

• Formulation Scientist: Prepare the draft master formula with all components and process steps.
• QA Department: Review and ensure the MFR meets regulatory requirements.
• Head – Manufacturing: Approve the MFR prior to batch production.

4. Accountability

Head – Product Development and Head – QA shall be accountable for the final authorization of the master formula record.

5. Procedure

5.1 MFR Content Requirements

The Master Formula Record should contain the following:

1. Product name, strength, dosage form, and batch size
2. List of active and inactive ingredients with their quantities
3. Equipment to be used during manufacturing
4. Detailed manufacturing steps including solution preparation, sterilization, and filling
5. In-process controls and critical process parameters
6. Packaging specifications and labeling instructions
7. References to relevant SOPs

5.2 Preparation Process

1. The formulation scientist drafts the MFR using a standardized template (Annexure-1).
2. All values and instructions should be unit-specific (e.g., mg/mL, °C, minutes).
3. Critical steps and control points must be clearly identified.
4. Ensure proper rounding of quantities and tolerances based on batch scale.

5.3 Review & Approval

• QA reviews the MFR for completeness, clarity, compliance with pharmacopeial standards, and regulatory filings.
• Final MFR must be reviewed by QA and approved by both Head – Product Development and Head – Manufacturing before issuance for production.

5.4 MFR Numbering and Version Control

• Assign MFR numbers as: MFR/ProductCode/Version (e.g., MFR/Ceftri500/V1.0)
• Any changes to composition or process must trigger a new version with a documented change control (refer to SOP/SIM/190/2025).

5.5 Storage and Access

• The approved MFR shall be stored in the controlled documentation archive, both in hard and electronic format.
• Access must be restricted to authorized personnel only.

6. Abbreviations

• MFR: Master Formula Record
• QA: Quality Assurance
• cGMP: Current Good Manufacturing Practices

7. Documents

1. Master Formula Record Template – Annexure-1
2. Change Control Form – Annexure-2
3. Review and Approval Log – Annexure-3

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q8(R2) – Pharmaceutical Development

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Formulation Scientist	QA Executive	Head QA
Department	Product Development	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Master Formula Record Template

Structured template to be used for drafting MFRs, including headers, batch size, instructions, and sign-off lines.

Annexure-2: Change Control Form

To be used when updating any portion of the MFR post-approval.

Annexure-3: Review and Approval Log

Date	Version	Reviewed By	Approved By	Comments
10/02/2022	1.0	QA	Head QA	Initial draft
18/06/2025	2.0	QA	Head QA	Updated for formulation scale-up

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
10/02/2022	1.0	Initial SOP issue	New product development	QA Head
18/06/2025	2.0	Expanded to include annexures and version control	GMP compliance update	QA Head