GXP Solutions | Good Manufacturing Practices (GMP)

What is a Good Manufacturing Practices (GMP) Audit?

A Good Manufacturing Practices (GMP) audit is an inspection of a manufacturing facility to verify that it complies with GMP regulations of:

Country of the Manufacturing Authorization Holder / Regulatory Filing Holder
Country of manufacture
Country of distribution

GMPs help create systems that ensure proper design, monitoring, and control of manufacturing processes and facilities. When applied as designed, GMPs help prevent instances of contamination, mix-ups, deviations, failures, and errors.

GMP covers all aspects of production within the biotechnology, medical device, and drug manufacturing industries to ensure high product quality. From the starting materials, Quality Management System (QMS), quality controls, premises, and equipment to the training and personal hygiene of staff.

Detailed, written procedures are essential for each process that could affect the quality of the finished product. Five (5) key components of GMP auditing include evaluating for products, people, processes, procedures, and premises.

Purpose of GMP Auditing

GMP auditing is the process of evaluating manufacturing facilities, processes, and procedures to ensure compliance with GMP regulations. These regulations are established by national regulatory agencies such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe.

GMP audits can be conducted by internal auditors, external consultants, or regulatory bodies themselves. The purpose of GMP auditing is to verify that companies are following required procedures and standards for product quality and safety. It also helps identify potential issues or areas for improvement in manufacturing processes.

Types of GMP Auditing

GMP Auditing applies to Sterile Manufacturing and Non-Sterile Manufacturing operations of different industries all associated with the final product.

Third-Party Internal Audit
Gap Analysis
QMS Projects
Inspection Readiness and Mock Inspection
Supplier /Vendor Auditing
- Manufacturing
  - Drugs manufacturing
  - Medical Device Manufacturing
  - Biologics Manufacturing
  - Contract Manufacturing Organizations
  - Contract Development Manufacturing Organizations
- Raw Material Suppliers
  - APIs – Active Pharmaceutical Ingredient
  - Excipients – Chemicals to stabilize and support the API within the drug.
- Primary, Secondary and Tertiary Packaging Components
  - Primary Packaging Components – Product contact surfaces (bottles, vials, ampules, blister packs, stoppers, tubes, etc.)
  - Secondary Packaging Components – Non-product contact surfaces (labels, caps, security seal, etc.
  - Tertiary Packaging Components – Outer packaging (individual folding cartons, package inserts, shippers, etc.
- Sterilizers for Components
- Sterile Cleanroom Supplies
- Third-Party Laboratory Testing (accredited and non-accredited)
- Packaging/Printed Materials
- Archive/Data and Document Management (DDM)
- Contract Research Organizations (CROs)

Importance of GMP Auditing

GMP audits protect the end user, by ensuring products are safe for use, meet customer expectations, and are produced consistently. GMP auditing confirms that a manufacturers products are made and controlled in accordance with health authority approved manufacturing processes, quality standards, current industry best practices, and that manufacturers comply with applicable health authority regulatory requirements and guidance documents.