Here’s a detailed checklist for auditing an ointment manufacturing facility, aligned with Good Manufacturing Practices (GMP), regulatory expectations (such as USFDA, WHO, EU-GMP), and quality standards. The checklist is categorized for clarity:

1. General Facility Requirements

• Location & Premises:

  • Facility is located in a clean, dust-free area.

  • Building structure prevents contamination (walls, floors, ceilings are smooth, cleanable, and crack-free).

  • Logical material and personnel flow to avoid cross-contamination.

• Environmental Controls:

  • Temperature and humidity are monitored and controlled.

  • HVAC systems validated and maintained.

  • Proper air pressure differentials (positive/negative) are maintained in critical areas.

2. Equipment and Utilities

• Manufacturing Equipment:

  • Equipment like ointment mixers, homogenizers, filling lines, and packaging units are qualified (IQ, OQ, PQ).

  • Cleaning procedures validated and documented (CIP/SIP if applicable).

  • Preventive maintenance records available.

• Utilities:

  • Purified water system validated and compliant with pharmacopeial standards.

  • Compressed air and steam quality monitored.

  • Calibration of instruments (e.g., temperature gauges, pressure indicators) is up to date.

3. Personnel and Hygiene

• Training & Competence:

  • Staff trained on SOPs, hygiene, and GMP.

  • Training records maintained and reviewed.

• Gowning & Hygiene Practices:

  • Proper gowning procedures for controlled areas.

  • Handwashing, sanitization, and movement restrictions observed.

4. Raw Materials and Components

• Receipt and Storage:

  • Raw materials and packaging components inspected upon receipt.

  • Quarantine and approved/rejected areas clearly labeled.

• Sampling and Testing:

  • Sampling done in designated controlled areas.

  • All materials tested and released by QC before use.

5. Manufacturing Process

• Batch Manufacturing Records (BMR):

  • Each step documented (weighing, mixing, filling, sealing).

  • Deviation handling and reconciliation of yields done.

• In-Process Controls:

  • Mixing time, temperature, viscosity, pH, and homogenization parameters checked.

  • Sample retention and trend analysis.

6. Packaging and Labeling

• Primary and Secondary Packaging:

  • Tube filling, sealing, and labeling operations verified.

  • Line clearance before and after every batch.

• Label Controls:

  • Correct label version used.

  • Reconciliation of printed components.

7. Quality Control (QC)

• Testing Protocols:

  • Finished product tested for assay, pH, microbial limits, viscosity, spreadability, etc.

  • Stability studies conducted and documented.

• Documentation:

  • COAs issued and cross-checked.

  • Lab instruments calibrated and maintained.

8. Documentation and Records

• SOPs:

  • Approved, controlled versions available at point-of-use.

  • Reviewed periodically.

• Records Management:

  • Manufacturing, QC, equipment logs properly maintained.

  • Document retention policy in place.

9. Validation and Qualification

• Process Validation:

  • Validation of mixing, filling, cleaning, etc.

  • Three consecutive batches for process validation.

• Cleaning Validation:

  • Procedures for product-to-product cleaning verified.

  • Swab and rinse tests performed.

10. Warehousing and Distribution

• Storage Conditions:

  • Ointments stored under specified temperature/humidity.

  • FIFO/FEFO practices followed.

• Dispatch:

  • Distribution records traceable to batch numbers.

  • Transport conditions validated.

11. Self-Inspection and CAPA

• Internal Audits:

  • Scheduled and surprise audits conducted.

  • Findings documented and tracked.

• Corrective and Preventive Actions (CAPA):

  • Root cause analysis done for non-conformities.

  • Effectiveness of CAPAs evaluated.

12. Regulatory Compliance

• GMP Certification:

  • Facility complies with applicable GMP guidelines (e.g., USFDA, WHO, EU-GMP).

• Product Registration & License:

  • All marketed products are registered and licensed appropriately.

This comprehensive checklist helps ensure ointment manufacturing facilities maintain consistent product quality and safety while being audit-ready.

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