GMP Compliance & Auditing.
Compliance services across your manufacturing processes.

What is GMP Compliance & Auditing?

Compliance requirements.

In Europe and worldwide, Good Manufacturing Practice (GMP) comprises a set of regulatory principles designed to uphold the quality, safety, and effectiveness of both human and veterinary medicinal products. GMP standards and procedures address diverse areas of the manufacturing process, aiming to uphold a consistently high standard of quality and ensure that products align with the prerequisites for Marketing Authorisation or Clinical Trial Authorisation.

Manufacturers are required to acquire a GMP Certificate, granted after the initial and subsequent site inspections. This certificate is based on the specific activities, relevant legislation, and the precise site address associated with the manufacturing processes.

To fulfil these responsibilities, GMP necessitates the establishment of a quality system focused on minimizing risks across the entire manufacturing process, starting from raw materials to the final product production. Risks can occur at various stages, including incorrect labelling, cross-contamination, or the use of incorrect ingredients. The potential for errors and risks is extensive, and GMP serves as the foundation for a quality system designed to prevent such occurrences.

Click for more information from the European Medicines Agency (EMA) on GDP.

Auditing overview.

Although the specific extent of GMP activities may differ based on the regulations applicable to a particular region or country, there is a consistent requirement for systematic and independent oversight of the manufacturing process to ensure compliance with GMP guidelines.

This requires comprehensive and efficient independent auditing and management of audit programs across all relevant areas to verify, and possibly enhance, the existing quality system and risk mitigation measures. It constitutes a critical component of continuous compliance, safety assurance, and the renewal process for GMP Certificates.

When conducting Good Manufacturing Practice (GMP) audits, it is essential to employ appropriate risk-based sampling and testing methods. These methods enable the identification and assessment of specific risks in the area under review, with the audit findings methodically documented in an audit plan.

Click for more information from the EMA on GMP Auditing.

Supporting your GMP Compliance & Auditing requirements.

Our GMP Compliance & Auditing & Inspections team is thoroughly experienced in the full scope of GMP compliance requirements, and the auditing services required to keep your manufacturing safe, compliant, and inspection ready at all times. Our internal and external GMP auditors are experienced and qualified and understand the latest in regional legislation changes and requirements.

Supported by a robust Quality Management System (QMS), we can seamlessly and efficiently adapt to the compliance needs of your distributed products. Our commitment to good communication, reliability, and trust aims to foster a successful and resilient strategic partnership throughout the entire life cycle of your product portfolio.

All of our services adhere to the regulations and principles of the EMA’s guidelines on compliance.