Above: Many opportunities are available to tighten up documentation of controlled environments with modern technology.
show that your facility is committed to corrective actions, any and all.
determination regarding your compliance.” Sort of like an offer to help you with your compliance concerns. However, not responding quickly and carefully will most likely result in further investigation. In addition, all Warning Letters are posted on the FDA’s site4
in html
format and are therefore indexed by search engines. Once you receive a 483, all anyone needs to do is type [Your Company/Lab’s Name] + FDA (or +483) into the search box, and there you are.
Your initial response must do three things: it must establish credibility, it must demonstrate acknowledgement of the observations and an understanding of the specific requirements referenced, and it must
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You can show commitment by working cross-departmentally; include a statement from all relevant department heads that briefly but specifically addresses each observation.
Each observation needs to have a corrective action-either planned or accomplished-and it must be feasible and deliverable within a predetermined time-frame.
Here are some tips-some simple, some in depth-for responding appropriately to 483 letters:
Get your response in on time and in writing. You have 15 days, so ensure that final proofing and substantive editing is done at least by day 10. In the first paragraph of the
response letter, be explicit in your understanding of and desire to comply with FDA regulations. Respond individually to each item that was addressed in the Warning letter. Be specific. Do not try to solve all issues in one paragraph or your response may be rejected, prompting further action from the FDA. Respond by importance - that is, respond individually to items most likely to impact product quality. Be detailed yet concise in each response. Outline how each deficiency will be corrected, and when, rather than how the deficiency came to be. Provide documentation of a corrective action commitment from the person responsible for it. Use positive statements; avoid language that implies fault. Address each item in the form 483 as an opportunity to fine-tune the quality and compliance systems and personnel. Include reference to how you
will be forwarding evidence to support the correction. For example: “Company X will use Veriteq’s validated monitoring and alarming system to provide reports on temperature recordings taken at 10 minute intervals month-by-month.” Product specifications and protocols of any new systems can be provided or offered in support of the corrective action plan. If the inspector noted something that you feel was an isolated incident, document this fact and note it in your response. Be sure your data is complete and accurate. If you find some of the observations were in error after receiving the 483, there is a formal dispute resolution process outlined in the agency’s Guidance for Industry - Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP5
.
Be proactive. Reassess your internal compliance programs -
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