GMP AND GDP
Good Manufacturing Practice (GMP) ensures that goods are manufactured consistently to meet their intended use, and it is vital that they are continuously monitored to ensure that they meet the quality standards and comply with requirements imposed by the health authorities. Our experienced and knowledgeable team of auditors within RiverArk can identify and define your needs per guidelines of GMP (compliance or validation requirements). They are also well versed with Good Distribution Practice (GDP), requirements mandated across the manufacturing lifecycle from the early delivery of raw materials to the distribution of final manufactured drugs to the end-user. Our flexibility and vast network allows us to provide a whole gamut of services in GMP/GDP according to EU GMP guidelines, USA cGMP regulations; ICH Q7 – GMP and GDP.
GMP/GDP Audits
- CMO Qualification
- Aseptic Environments
- IMP Manufacturing
- Large Scale Production Facilities
- Inspection Readiness Support
- Document/Records
- Storage Centres
- Distribution Centres
- Test Laboratories
- API and IMP