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.
Find out how ADAMAS Consulting can help with your next project
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;
Gmp Audit services
- GMP Auditing – Suppliers, Vendors, Service Providers
- GMP Auditing – Internal Departments
- Mock Inspections
- Pre-approval Inspections
- GMP Training
- SOP – Development, Revision, Evaluation
- Inspection Interview Training
- GAP Analysis
- Facility Assessments
- Facility Walk Thru
Regulations and Standards
- FDA 21 CFR Parts 11, 210, 211
- EudraLex – Volume 4
- EU GMP Annex 1, 11
- ISO 9001:2015 – Quality management systems
- ISO 13485:2016 – Medical devices — Quality management systems
- ISO/IEC 17025:2017 – General requirements for the competence of testing and calibration laboratories
- ISO 11137:2013 – Sterilization of health care product
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.
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.