Van Zyl GMP International
There is only one
Est. 1999
Good Manufacturing Practices, Good Clinical Practices, Good Laboratory Practices
Good Storage Practices and Good Distribution Practices
Good Manufacturing Practice:
Good Manufacturing Practice (GMP) is that part of quality assurance that ensures
that pharmaceutical products are consistently produced and controlled to the quality
standards appropriate to their intended use and as required by their marketing authorization.
GMP covers all areas of manufacturing, including premises, equipment, materials,
cleaning, personnel, documentation, and many other related matters in production
and quality control. "GMP is aimed primarily at diminishing the risks inherent in
pharmaceutical production, such as cross-
Good Clinical Practice:
Good Clinical Practice (GCP) is a standard for clinical studies which encompasses the design, conduct, monitoring, termination, audit, analyses, reporting and documentation of the studies and which ensures that the studies are scientifically and ethically sound and that the clinical properties of the pharmaceutical product (diagnostic, therapeutic or prophylactic) under investigation are properly documented.
Main Services:
Our services include assistance and advice -
- Inspections and audits of Active Pharmaceutical Ingredients (APIs) and Finished Product (FP) manufacturing sites
- Preparatory inspections and gap analysis of sites due for regulatory inspections such as EU, FDA, TGA and WHO
- Inspections of Contract Research Organizations (CROs) for clinical trials, bio-
equivalence studies and biowaivers - Bio-
equivalence study monitoring