GMP and GDP Audits of API manufacturers

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planta-quimicaAPI (Active Pharmaceutical !ngredient) providers audits are performed according to current regulation EU GMP part II and GDP compliance according to directive UE 2015/C95/01 which establish the principles of good distribution practices to the API manufacturers.

 

 

Benefits:
  • Auditors with accredited experience
  • Auditors in staff
  • Local support in projects in India or China
  • Tailor made Audits
  • CAPAS Follow-up until closure

Audits Process:

Information collection

To obtain the required information for the audit:

  • New provider or follow-up audit
  • In case of a new provider: development of a questionnaire to collect information prior to the audit
  • Technical agreement in effect
  • o Specifications and Analytical Method
  • Historic (batches, complaints, …)
  • Additional information
  • DMF in effect

Planning and Execution

Steps:

  • Date and agenda setting
  • Audit execution
  • Audit Summary: provided one week after the audit
  • Final report writing. An initial draft is reviewed with the client to establish the significance of the observations and explain the audit development, this draft will be sent prior to 15 days to the client
  • Once accepted, the final report is sent to the client prior to 1 month, along with an audit summary with observations and conclusions

Follow-up

After final report is sent:

  • Submission to provider of a summary of observations
  • Consensus with provider on CAPAS to perform
  • Periodic follow-up of CAPAS until closure

 

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