GMP Compliance Certification by TÜV SÜD gives certainty

Dipl. Ing. Walter Ritz

Tüv Süd's GMP Compliance Certification is an important service for manufacturers and equipment suppliers that must follow GMP regulations directly or indirectly. The internationally operating TÜV SÜD Group has 19.000-plus staff at over 800 locations.

The EU GMP guidelines governing medicinal products for human and veterinary use specify the principles of good manufacturing practice (GMP) in respect of medicinal products for human use and some medical devices laid down in Commission Directive 2003/94/EC. Manufacturing in accordance with GMP principles imposes very strict demands on manufacturers and equipment suppliers that operate in the pharmaceutical, medical device and cosmetic industries.

Tüv Süd's GMP Compliance Certification gives manufacturers additional certainty that their required comprehensive documentation, production equipment and the actual production process meet the strict requirements of the EU GMP regulations. The certificate supports but does not replace the companies' duty of qualification and validation which includes the requirement of authority inspection to obtain a manufacturing licence.

Within the framework of its GMP Compliance Certification, Tüv Süd carries out a comprehensive assessment programme on site at the manufacturing companies that includes the following issues and subjects:

•    Document review (quality management manual, SOPs/work instructions, training programmes, QV documentation, manufacturing documentation, non-conformity reports, monitoring and measuring equipment, etc.);
•    Inspection of the premises (production, storage and shipping areas, common rooms, quality control laboratories, service rooms, etc.);
•    Production equipment;
•    Production processes;
•    Personnel hygiene;
•    Ancillary equipment (water treatment, air filtration and distribution, production and distribution of compressed air etc.).

Equipment suppliers also benefit from Tüv Süd's GMP Compliance Certification as it assures them that the design, selected materials and documentation of their products and equipment meet the GMP requirements and that their equipment is ready for approval and suitable for use in cleanrooms. To the owners of such a system, machine or component the certificate offers the advantage that the supplier's documentation can be used as a basis on which to build full GMP certification.

Equipment suppliers must also pass a comprehensive assessment programme before they obtain the GMP Compliance certificate. The assessment includes the following elements of the GMP system:

•    Document review (quality management manual, CE risk analysis, P&IDs, equipment parts list, design drawings, operating/service manuals, approval/qualification documentation, etc.);
•    Technical testing of the component/system (product design, functionality, system safety, cleanability, maintainability);
•    Inspection of the premises (production areas and storage and shipping areas).

Tüv Süd's GMP Compliance Certificate was developed and presented in 2011. Today, manufacturers in the pharmaceutical and cosmetic industries, but also suppliers of cleanroom equipment and providers of software services, have come to realise the benefits offered by certification – assurance of legal compliance, ideal integration of components, equipment and machinery, and comprehensive documentation that can be presented to potential customers.

In view of these advantages, Tüv Süd's GMP Compliance Certificate is in rising demand, not only in Germany and Austria, but recently increasingly in the Russian Federation too. The Russian companies aim not only to establish a quality management system in accordance with the ISO 9001 standard, but also to implement the international GMP standard. This combination offers ideal conditions for manufacturing at the highest level and for permanently proving the achieved level of quality in third-party GMP audits.