current Good Analytical Laboratory Practices (cGALP)

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 Auditing pharmaceuticals quality control Laboratory
                                                                  

Auditing quality control laboratory is must for continuous improvement and regualotory requirements. It helps to keep QC laboratory in high compliance level and maintain best practices through continuos improvement by training and gap analysis.

 

There is a guideline from US FDA for inspection pharmaceuticals QC laboratory it includes chemical lab and Micro lab.
 
Pharmaceutical Quality Control Labs
 

Audit check list for Pharmaceutical Quality Control Labs by PICScheme

 
Microbiological Pharmaceutical Quality Control Labs
 


 
Auditing Guide from APIC


World Health Organization Public Inspection Reports (WHOPIR)

The World Health Organization Public Inspection Reports (WHOPIR) is a summary of the inspection report of

  • a manufacturing site for Active Pharmaceutical Ingredients (APIs);
  • a manufacturing site for Finished Products (FPs);
  • an organization such as a Contract Research Organization where a bioequivalence study or other clinical study had been performed (CROs);
  • a quality control laboratory
The WHOPIR reflects the inspection report and gives a summary of the observations and findings made during the inspection, but excludes confidential proprietary information. It indicates also the date and duration of the inspection as well as  the scope of the inspection.
 
The reported inspection reports are from India & china companies. Few examples are Ranbaxy, Cipla, Matrix, Lupin, IPCA, Aurobindo, Sitec lab,Vimta lab etc
 
To view/read the WHO inspection report click WHO inspection reports
 
 
 
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