responding to inspection observations

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You’ve hosted a GMP regulatory inspection. After a few weeks you receive the preliminary GMP inspection report, now it’s time to respond in a manner that makes the regulatory authority confident that you will get your things in order.

Besides drafting proper CAPAs we have some tips to make sure that you respond to the inspection report in a way that instills confidence.

Basic GMP inspection response tips

  • Ensure you have proper grammar and spelling in your report. Many grammar mistakes make it seem like you didn’t take your time with the report but rushed it.
  • Always check the guidelines. When you have an observation in your report, double check if it’s valid.
  • KISS: keep it short and simple.
  • Ensure that you are consistent with abbreviations/terms throughout your response,
    • If you refer to the Quality Assurance department/people with QA; then stick to that abbreviation. Try to avoid synonyms like “Quality Unit” or “Quality Manager”. consistency is key.
  • Don’t use non-industry standards when abbreviating; QA/QC/WFI/GMP are examples of acceptable standards.
  • Avoid abbreviating words that are not commonly abbreviated in formal communication. Write “department”, not “dept.”.
  • Be consistent in your styling, line breaks, line-spacing and style of writing,
    • Small details matter; be consistent in your use of capitals; do not use “SOP” in one instance and “sop” in another instance. Write “WFI” not “wfi”.
  • Don’t refer to observations as “advice” or “tip”, it’s always a formal observation and must be treated as such.

High quality responses

  • Make sure you respond to the ENTIRE observation. Certain parts of observations are sometimes skipped in answers because they seem “obvious”/”everybody knows that”, be precise and complete.
  • Avoid raising new questions. Your answer should not lead to more questions. It should be a straightforward answer; I will do X, because of Y, using standard “Z”. When you expand too much, or if you are too vague you risk additional questions that need to be answered, further delaying the process.
  • Don’t use “etc.”, rather type out an exhaustive list than to omit details.
  • Don’t overdo it. When there’s an observation for something minor; e.g. a GMP qualification protocol lacks exact timelines, don’t revise the whole SOP, the qualification program and overhaul the entire QMS. Fix the timelines and see if they could be missing somewhere else. Inspectorates want to see a state of control; fixing things that don’t need fixing may give off the wrong signal; not knowing how to prioritise.
  • Don’t confuse OOL and OOS; this mistake is made very, very often. Check twice before you submit the report.
  • Don’t repeat the observation. Only answer the observation.
  • Avoid vague terminology, examples of this;
    • better compliance
    • more clarity
    • appropriate care
    • further steps
    • comprehensive
  • Don’t enter into “teacher” mode. Avoid explaining simple subjects because you think the inspector does not understand basic concepts. In 99% of the cases you are misinterpreting the observation. If it seems simple, it usually refers to something more complicated.
  • Don’t put failsafes in your inspection response. For example; “we allow a maximum of 2 extensions of the timelines in this report”. When you are promising something to an inspectorate, you stick to that promise.
  • Don’t offload the responsibility for correcting observations to QA. Process owners/stakeholders should be involved/made responsible to prevent repetition of the observations.
  • New SOP’s don’t fix a problem by themselves. We often see a response in GMP inspection responses; “we will implement a SOP for the validation of X” for example. This is insufficiently detailed; how will the new GMP SOP resolve the observation?
  • Don’t dedicate CAPA’s to the country/region of the inspectorate. Inspectorates are concerned about patient safety worldwide. Avoid writing responses like; “the next batch shipped to the EU will only be shipped if it meets the new criteria”. But what if there’s a batch before that being sent to the U.S.? Do the new criteria not apply to U.S. based patients?

Conclusion

Inspection responses are no easy job. They should not be taken lightly. An insufficient response may lead to the loss of a license or certificate. Involve as many subject matter experts as possible and seek outside help if you are inexperienced with writing inspection response letters. If you are about to write a GMP inspection response, check these tips to make sure you avoid the common (and less common) pitfalls.

About the author

julian.koster@pcs-nl.com

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