DRUG MANUFACTURERS ARE REASSESSING HOW THEY MANAGE REGULATORY INSPECTIONS as they shift focus onto the challenge of conveying the strength of their quality systems to find and address problems and risks. The diversity of inspectors and regulatory agencies that manufacturers routinely face also is prompting them to clarify and refine their approach to managing inspections. The consensus from both sides of the Atlantic is that opening the communication channels is key to a positive inspection outcome and that putting up barriers to this interchange is counterproductive. The experts agree that the following are good inspection facilitators: • operator receptivity to dialogue • asking investigators to clarify requests and findings as needed • having records/applications available • being truthful • volunteering information that can help mitigate investigator concerns • understanding and addressing rather than arguing with concerns raised, and • supporting dis-agreements with data. Regulators want to see a sense of urgency from firms about their CAPA commitments in responding to inspection findings.
VOICES FROM THE DIALOGUE:
• Industry consultant Richard Davis on OOS investigations and inspection preparation (Appendix I, pp. 14)
• Paraxel consultant Peter Smith on interacting during inspections (Appendix II, pp. 19)
• Richard Davis on responding to 483s (Appendix III, pp. 26)
CONTENTS:
2……Communication Is The Challenge
2……Firms Can Trip On Their Own Hurdles
4……Investigators Want Operator Input
5……Honesty Is The Best Policy
5……When In Doubt, Ask
6……Have Records Available, Site Active
8……Meetings: With Whom and When?
9……What If You Disagree?
11….Give Action Timelines In 483 Responses
13….OOS Investigations Indicate the Culture
