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Auditing API Facilities

Auditing API Facilities

Duration: 60 Minutes

Faculty: Dr. Tim Sandle      Level: Intermediate      Course ID: 1097


Auditing an API Facility is not a “walk in the park”. One needs to really learn API GMP and where and what to look for during an audit. Recent publicity surrounding API manufacturing and testing sites, have illustrated how poorly too many API facilities are performing during regulatory inspections. The deficiencies that are now being identified exist in spite of previous audits and regulatory inspections. Many, if not all of the major deficiencies did not just happen. These deficiencies have likely existed for a long time and this webinar program will help interested parties be better prepared to audit these facilities.

Knowing the API GMP, its intent, and what to focus on will help make for a more effective and productive audit. It makes no difference if you want to perform a self-audit or visit a supplier – you need to learn where to look and what to look for during the site visit. This is a key objective of this program. Participants should understand the concepts contained in the API GMP (ICH Q7)

Why should you Attend:

If you or your company uses or purchases API and or manufactures or tests API, then you can benefit from this Webinar. You will be able to profit from the instructor’s experience in the manufacturing and testing of API and an understanding of the regulations and guidances that have applied to these materials. Understanding the rules of the game will make you a better and a more effective auditor. Learn what you need to review before you audit, what you need to focus on when performing an audit, and when you need to send a strong and direct message to the firm you are auditing – even if that firm is your own!

Areas Covered in the Session:

  • Preparing to perform an audit
  • What to review
  • What to learn
  • Proper communication to the audited firm or location
  • How much time do you need?
  • Where do you look?
  • What do you look at or look for?
  • What are the systems you need to examine
  • What are the Red Flags to look for during an audit?
  • Use the ICH Q7 Guidance as a guide
  • Checklist or no checklist?
  • Closing the audit
  • Next Steps following the audit

Who Will Benefit:

  • Firms that manufacture or analyze API and firms that purchase API for their drug product.
  • Quality Control and Quality Control personnel
  • Engineering and Production Management
  • Inspectors and auditors
  • Purchasing and materials management personnel
  • Distribution personnel
  • R & D personnel responsible for methods and procedures that will be used by API functions
  • Regulatory Affairs personnel responsible for filing DMF, NDA, ANDA and another FDA related filings and registrations

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Pharmaceutical Microbiologist