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.

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Vendor qualification audits.
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IMP production facility audits.
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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

Quality services

  • 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. N.G.

Associate Director, Biopharmaceutical company

Contact Us

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.

The ADAMAS Corporate Brochure 2016

 

Brochure – Please download the ADAMAS brochure describing our QA services and contact details.

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Regulatory Environment

 

The development of medicines is the most regulated industry in the world, and compliance at each stage of the research and development process, as well as after licensing, is critical to ensuring high quality and safe medicines reach patients in a timely manner.

adamas-quality-assurance-services

 

ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.

 

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How to be a Clinical Auditor

So you want to be a Clinical Auditor? An article written by CEO.Dr.

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Benchmarking Data

 

Please download our benchmarking data sheet, to see how these data compare with your own performance. To discuss a more detailed report, or analysis of a data subset, please get in touch.

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Is your QMS compliant?

Identify whether your QMS is compliant to the upcoming ICH GCP Addendum


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Is your QMS compliant?

Identify whether your QMS is compliant to the upcoming ICH GCP Addendum


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ICH (E6) R2 Addendum - Step 4

 

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How to be a Clinical Auditor

So you want to be a Clinical Auditor? An article written by CEO.Dr.


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How to be a Clinical Auditor

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How to be a Clinical Auditor

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