Good Manufacturing Practice
ADAMAS has the technical knowledge and over 20 years average experience working within the GMP environment on a global level. Our audit expertise encompass the full range of GMP activities from component and label manufacture to aseptic fill/ finish and distribution. Our audit services include CMO qualification; IMP manufacturing; aseptic environments; large-scale production facilities; and inspection readiness training.
Vendor qualification audits.
IMP production facility audits.
Inspection readiness training.
Recent examples of our work:
GMP Audits of API manufacturers
Sterile and non-sterile CMO audits
Programme of supplier qualification audits
Good Distribution Practice
ADAMAS has an international presence and knowledge to provide support for complex global distribution supply chain. Our GDP experts provide audit services including cold chain distribution, controlled substance distribution, and named patient distribution.
To ensure that you are compliant with industry standards and in line with regulatory expectations, we can offer services in the following areas;
- Inspection readiness
- GMP Training
- Aseptic/Sterile Environments
- Records Storage/Archive Facilities
- Contract Laboratories
- Internal Audits
- Supplier Qualification
- Quality Systems (CAPA, Complaint Management)
- Materials System (Materials Management and Controls, Sampling Requirements/Specifications)
- Production System (Process validation, Cleaning validation, Batch record issuance)
- Facilities and Equipment
It was great to meet you and start working with you, your expertise will be precious help for us, QA team, and the pre-clinical team.N.G.
If you've got any questions or queries about our services, careers, or training, please get in touch.
We have 500+ years combined experience, working around the globe there isn’t anything we’ve not encountered in our sector. We're very approachable and happy to help.