GMP Example Table

Audit Type

Drug Product (DP)

Combination Products

Medical Device

Drug Substance (DS)/ API


Cell Bank Manufacture


Packaging and Labelling

Warehousing Storage / Distribution

Printed Packaging Components

Components/ Consumables

Service Providers


• Sterile (fill/finish)

     • Vials, Cartridges, Ampule

• Non-Sterile Formulation

     • Tablets, Capsules

     • Sachets (powder fill) 

• Injectable pens

• Kit assembly

• Implanted

• External

• Indented for sterile use

• Indented for non-sterile use

• Analytical Chemistry

     • Release

     • Confirmatory 

     • Stability

• Microbiology  

     • Sterility

     • Environmental Monitoring

     • Identification

• Master Cell Bank (MCB)

• Working Cell Bank (WCB)

• Manufacture

• Repackaging

• Primary Packaging

• Secondary Packaging

• Drug Product, Finished Bulk DS, API, Cell Bank, Raw Material

• Cold chain Distribution

• Labels

• Package Insert/ Prescribing Information

• Carton 

• Tamper Evident Seals

• Anti-counterfeit Printing

• Processing 

     • Filters 

     • Bags, Tubing, Bottles 

     • Media 

     • Resins 

     • Raw material chemicals

• Packaging 

     • Vials, Cartridges, Ampules 

     • Stoppers 

     • Needles

• Calibration

• Sterilization 

     • Gamma Irradiation

     • Electron Beam

The ADAMAS Corporate Brochure 2016


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

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’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.


How to be a Clinical Auditor

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

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.

Is your QMS compliant?

Is your QMS compliant?

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

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.

How to be a Clinical Auditor

How to be a Clinical Auditor