GMP audits of immediate packaging material manufacturers

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rollosAudits to immediate packaging material manufacturers will be performed according to regulation ISO 1537. Requirements for the application of ISO9001:2008 considering good manufacturing practices, if material is a sterile, all regulation related to sterile products is applied (Annex I GMP EU Part I).

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
  • Specifications and Analytical Method
  • Historic (batches, complaints, …)
  • Additional information

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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