GMP (Good Manufacturing Practice) audits are a fundamental tool for ensuring quality in the production of medicinal products and cosmetics. GCB conducts independent assessments of process compliance, infrastructure, and documentation in accordance with current GMP standards and both national and international regulatory requirements.

Table of contents

  1. The Importance of GMP Audits in the Production of Medicinal and Cosmetic Products
  2. The GMP Audit Process – Step by Step
  3. Types of GMP Audits Offered by GCB

The Importance of GMP Audits in the Production of Medicinal and Cosmetic Products

A GMP audit verifies whether manufacturing sites, quality control laboratories, and storage facilities operate in compliance with Good Manufacturing Practices. These audits help to:

  • ensure that products are manufactured under conditions that guarantee safety and quality,
  • identify process risks and gaps in production systems,
  • meet regulatory requirements and industry standards,
  • build market credibility and trust among clients and partners.

The GMP Audit Process – Step by Step

GMP audits involve a comprehensive analysis of all stages of production and quality support:

  • review of raw material documentation, specifications, and supplier qualifications,
  • assessment of production processes — control of operations and intermediate steps,
  • verification of quality control systems and procedure validation methods,
  • evaluation of personnel competence, training, and qualifications,
  • inspection of storage, transport, and product stability conditions,
  • verification of CAPA (Corrective and Preventive Actions),
  • preparation of an audit report with findings, evaluations, and recommendations.

Types of GMP Audits Offered by GCB

We tailor the audit format to the client’s needs and the nature of their operations. Available options include:

  • On-site audits – full inspections conducted at the manufacturing site,
  • Hybrid audits – a combination of remote and on-site inspections,
  • Remote audits – off-site review of documentation and processes,
  • Pre-inspection audits – preparation for upcoming regulatory inspections,
  • CAPA audits – evaluation of implemented corrective and preventive actions.

All our GMP audits are conducted impartially and objectively, adhering to the highest quality standards. Through independent evaluations, we support organizations in maintaining compliance, product quality, and a competitive edge.