Regulatory

MicroSafe Services' customers have to comply with regulatory standards according to FDA or European requirements. As our customers, MicroSafe Services also complies with the same regulatory standards. We are regulatory inspected by the authorities and our customers and are in compliance with GLP as well as cGMP.

MicroSafe Services Study Driectors can advise you on which standard is most suitable to your testing.

GMP Standards

GMP (Good Manufacturing Practice) standards, and especially chapter 6 "Quality Control" of the EU GMP guide and 21 CFR 211.22 and 211.160-198 apply to laboratory controls for product release as well as to GMP monitoring of production environments.

The GMP inspectorate has granted MicroSafe Services a GMP certificate from the Dutch Ministry of Health on the basis of The EU Guide on Good Manufacturing Practice. This certificate covers release testing for pharmaceutical products and includes virology tests for biotechnology products, bacteriology tests and mycoplasma tests for vaccines, biotechnology and other biological products.

GLP Standards

Good Laboratory Practice GLP (Good Laboratory Practice) standards are applicable to safety testing and development testing activities. MicroSafe Services performs these studies in compliance with the OECD Principles of Good Laboratory Practices. Following inspection by the Dutch GLP monitoring authority an endorsement of GLP compliance was granted to MicroSafe Services. We are regularly re-inspected in accordance with the GLP compliance program of the national authorities. GLP compliance has international recognition via a memorandum of understanding on the mutual acceptance of GLP inspections signed between the United States and the Dutch authorities.

Standard guidelines and reference manuals

Studies and testing are performed according to the references required by the customer. Standard reference manuals are the European Pharmacopeia, the United States Pharmacopeia, The Code of Federal Regulations, ICH Guidance documents, FDA Points to Consider, and EU Guidance to Manufacturers documents. Where harmonized procedures are adopted, MicroSafe Services follows these in the standard protocols. If no harmonized procedures exist, protocols are used according to European standards, US standards, and where possible a combination of both. Where customers have specific needs exceeding the standard regulations, MicroSafe Services adapts the protocols to the requirements of the customer. We will honor commitments made by our customers in product registration dossiers in customer specific protocols.

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