Procedure for Assembling Equipment for Ointment Manufacturing

Department	Production/Engineering/Quality Assurance (QA)
SOP No.	EQ-022
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 establish a systematic process for assembling equipment used in ointment manufacturing. Proper assembly ensures that equipment functions optimally, maintains GMP compliance, and prevents cross-contamination.

2. Scope

This SOP applies to all personnel responsible for assembling equipment such as mixing tanks, homogenizers, heating vessels, and filling machines in the ointment manufacturing area.

3. Responsibilities

• Production Supervisor: Ensures that all equipment is assembled correctly before manufacturing starts.
• Maintenance Engineer: Assembles and verifies proper functioning of equipment.
• Quality Assurance (QA) Officer: Conducts final inspection and approves equipment readiness.
• Operators: Assist in assembling equipment components and ensure adherence to cleaning procedures.

4. Accountability

The Production and Engineering Managers are accountable for ensuring that all equipment is assembled correctly, documented, and verified as per GMP standards.

5. Procedure

5.1 Pre-Assembly Checks

• Ensure that all equipment components are clean, dry, and free from residues.
• Verify that all required tools and gaskets are available for assembly.
• Check the equipment calibration status and ensure it is up to date.

5.2 Assembling Mixing Tanks

• Position the mixing tank in its designated location.
• Attach the mixing blades securely and ensure they rotate freely.
• Connect the required hoses and valves for material transfer.
• Tighten all clamps and seals to prevent leaks.

5.3 Assembling Homogenizer

• Install the homogenizer shaft and impellers as per manufacturer guidelines.
• Ensure the homogenization chamber is securely locked in place.
• Check motor alignment and lubrication.
• Verify that safety interlocks are functional.

5.4 Assembling Heating and Melting Vessels

• Attach the heating elements and temperature sensors.
• Connect the steam or electrical supply for heating.
• Check for leaks in heating coils and temperature control systems.

5.5 Assembling Filling Machine

• Install filling nozzles and secure them firmly.
• Calibrate filling volume settings as per batch requirements.
• Check the movement of piston pumps or peristaltic pumps.
• Test the conveyor system and ensure smooth movement.

5.6 Equipment Verification

• Conduct a dry run to check the functionality of each component.
• Verify that all safety interlocks and emergency stops are working.
• QA personnel must perform a final inspection and approve the assembly.

5.7 Documentation and Approval

• Record all assembly steps in the Equipment Assembly Log.
• Obtain QA approval before starting manufacturing.
• Label assembled equipment as “Ready for Use.”

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• PPE – Personal Protective Equipment

7. Documents

• Equipment Assembly Log (Annexure-1)
• Equipment Verification Checklist (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• 21 CFR Part 211 – Current Good Manufacturing Practices
• Equipment Manufacturer Manuals

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Equipment Assembly Log

Date	Equipment Name	Component Installed	Assembled By	Verified By
01/02/2025	Mixing Tank	Blades and Hoses	John Doe	QA Officer
02/02/2025	Filling Machine	Nozzles and Piston Pumps	Jane Smith	QA Officer

Annexure-2: Equipment Verification Checklist

Equipment Name	Component Checked	Status (✔/✖)	Verified By
Mixing Tank	Blade Alignment	✔	QA Officer
Homogenizer	Motor Function	✔	QA Officer
Filling Machine	Nozzle Calibration	✔	QA Officer

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