Good Manufacturing Practice (GMP) ensures products are consistently produced and controlled to the quality standards appropriate for their intended use and conform to the regulatory requirements stipulated by health authorities.
GMPs are fundamental to any manufacturing industry and are often required to be implemented in plants and factories by national governments. Intertek’s team of experts can assist you with the development and evaluation of GMP programs for the following industries and more
With an in-depth knowledge and industrial experience in the code of GMP, together with an extensive international network of experts, Intertek is able to identify and define your needs in conformance to GMP guidelines, be they compliance or validation requirements.
We deliver pharmaceutical GMP auditing solutions, including audits to:
- Pharmaceuticals - OTC drugs (NSF-ANSI 455-4)
- Pharmaceutical GMP audits (US FDA 21 CFR Parts 210/211)
- Pharmaceutical EU GMP Compliance Audits (EudraLex Volume 4)
- Pharmaceutical GMP Compliance Audits for Health Canada (GUI-0001)
- ICH Q7/Q9/Q10 Quality Systems and GMP Audits
- Custom Audits for Pharmaceutical Manufacturers and Suppliers
Intertek offers the following services:
- Laboratory pre-auditing
- System training for ISO/IEC 17025 and CNAS
- Directives introduction and testing process demonstration
- Correlation sample testing and correction suggestion
- Laboratory management system and technical audits
Additionally, Intertek can provide professional advisory and management services for all your laboratories – helping you to train qualified laboratory professionals, get in-depth and correct understanding of hazardous substance testing methods set by different countries and establish comprehensive laboratory management systems.
Intertek is your partner in quality assurance from design phase to performance qualification. Intertek will work closely with you, either early in the project timeline or interpose at any point at your request, to provide the most cost-effective measures in attaining GMP certification, chemical lab consultation, and a competitive edge in the market.
