SOP Guide for Pharma

Creams: SOP for Pre-Production Checks in Cream Manufacturing – V 2.0

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Creams: SOP for Pre-Production Checks in Cream Manufacturing – V 2.0

Standard Operating Procedure for Pre-Production Checks in Cream Manufacturing

Department Creams
SOP No. SOP/CRM/041/2025
Supersedes SOP/CRM/041/2022
Page No. Page 1 of 6
Issue Date 18/09/2025
Effective Date 23/09/2025
Review Date 18/09/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the essential pre-production checks that must be performed before initiating the manufacturing process for cream products. These checks are crucial to ensure that the manufacturing environment, equipment, and raw materials are ready and compliant with the required quality standards, thus preventing production issues and ensuring product consistency.

2. Scope

This SOP applies to all cream products manufactured within the Creams Department. It includes checks on raw materials, equipment, manufacturing areas, and personnel readiness before production begins to ensure that the manufacturing process can proceed smoothly and within compliance with Good Manufacturing Practices (GMP).

3. Responsibilities

4. Accountability

The Head of Creams Manufacturing is responsible for overseeing the pre-production checks process. The QA Manager is accountable for ensuring that all pre-production checks are conducted and documented according to this SOP, and that the production process can begin once all checks are confirmed as satisfactory.

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5. Procedure

5.1 Raw Material and Ingredient Check

  1. Verify that all raw materials required for the cream formulation are available and ready for use. This includes confirming the following:
    • All raw materials are in the correct quantities.
    • Raw materials are within their expiration dates.
    • All materials meet the required quality standards as per the Master Formula Record (MFR).
    • Materials are properly labeled and stored in the correct conditions (e.g., temperature, humidity).
  2. The QC team is responsible for conducting a quality check on the raw materials, including verifying certificates of analysis (CoA) and conducting any required testing (e.g., moisture content, microbial testing).

5.2 Equipment Readiness Check

  1. Verify that all equipment to be used in the cream manufacturing process is available, calibrated, and cleaned. This includes:
    • Mixers and homogenizers
    • Heating and cooling units
    • Filling machines
    • Weighing scales
    • pH meters
  2. Check the calibration of all measurement instruments to ensure accuracy during the manufacturing process. This includes:
    • Weighing scales
    • Viscosity meters
    • pH meters
  3. Ensure that all equipment is cleaned and sanitized as per the equipment cleaning SOPs. Any equipment found to be in non-compliance must be reported, and corrective actions must be taken.

5.3 Environmental Readiness Check

  1. Ensure that the manufacturing environment is clean, organized, and free from any contamination risks. This includes:
    • Confirming that the production area is clean and meets GMP standards.
    • Ensuring that the temperature, humidity, and air quality in the production area are within the specified ranges for cream manufacturing.
    • Verifying that the lighting, ventilation, and safety equipment (e.g., fire extinguishers, emergency exits) are functional and accessible.
  2. Ensure that the materials handling area is organized and free from any cross-contamination risks. All raw materials should be segregated and clearly labeled to avoid mix-ups during production.
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5.4 Personnel Readiness Check

  1. Confirm that all personnel involved in the manufacturing process are trained, qualified, and ready to begin production. This includes:
    • Ensuring that production, QC, and QA personnel have completed their required training.
    • Confirming that personnel are wearing the appropriate personal protective equipment (PPE), such as gloves, masks, and lab coats.
    • Ensuring that all personnel are briefed on the specific procedures for the day’s production run.

5.5 Review of the Master Formula Record (MFR)

  1. Before production begins, ensure that the Master Formula Record is complete and up-to-date. The MFR should include:
    • Formulation details (ingredient list, concentrations, order of addition)
    • Manufacturing instructions (mixing, heating, cooling processes)
    • Quality control specifications (e.g., pH, viscosity, microbial testing)
    • Packaging instructions (e.g., type of containers, labeling requirements)
  2. Review any changes made to the MFR since the last production run to ensure all updates have been accounted for and implemented.

5.6 Documentation of Pre-Production Checks

  1. Complete a Pre-Production Checklist (Annexure-1) that documents the completion of all required checks. The checklist should include:
    • Raw material verification
    • Equipment readiness check
    • Environmental readiness check
    • Personnel readiness check
    • MFR review
  2. Any issues or discrepancies identified during the pre-production checks should be documented, and corrective actions must be taken before production can begin.
  3. The Pre-Production Checklist must be signed off by the QA Manager before production can proceed.

5.7 Final Approval to Proceed with Production

  1. After all pre-production checks have been completed and documented, the QA Manager provides final approval to proceed with production. This approval is based on the successful completion of all checks and the assurance that all necessary conditions are met for a smooth production run.
  2. The Production Team is then authorized to begin manufacturing according to the finalized MFR.
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6. Abbreviations

7. Documents

  1. Pre-Production Checklist (Annexure-1)
  2. Master Formula Record (MFR) (Annexure-2)
  3. Batch Record (Annexure-3)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Pre-Production Checklist

Check Item Completed (Yes/No) Remarks
Raw Material Verification Yes All materials verified and within specification
Equipment Readiness Check Yes All equipment calibrated and cleaned
Environmental Readiness Check Yes Production area confirmed as clean and compliant
Personnel Readiness Check Yes All personnel trained and wearing PPE

Annexure-2: Master Formula Record (MFR)

Product Name Ingredients Process Steps QC Specifications
Moisturizing Cream Water, Glycerin, Hyaluronic Acid Mix, Heat to 65°C, Cool to 25°C pH 5.5-6.5, Viscosity 3000-3500 cP

Annexure-3: Batch Record

Batch Number Test Date QC Result Approval Status
12345 18/09/2025 Pass (pH 5.6, Viscosity 3200 cP) Approved

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/03/2024 1.0 Initial Version New SOP Creation QA Head
01/03/2025 2.0 Format Revision and Updates Standardization of Document QA Head
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