What is anticipated as “Good auditing practice”? What are Do’s and Don’t’s for audits?
The behavior during audits for the auditor and auditee is closely inter-related. It is hereby only generally described as what is commonly believed as “Good auditing practice” and not specifically distinguished for the role of the auditor and auditee. After that, the next chapter will in more detail cover the Do’s and Don’t’s during inspections related only to the role and responsibility of the auditee (i.e. companies being audited).
During an audit the auditor should manage and steer the audit process by raising open questions (“Who?” “When?” “How?” or: “Please explain . . .” etc.). Afterwards it is important to wait and listen for the answer / feedback from the persons being audited. The answers provided by audited persons should carefully be documented and evaluated altogether with gathered own evidence such as observations or document contents. The evaluation of the audit evidence should also consider a confirmation of the understanding (“Did I get you right with . . . ?”, “What do you mean with your explanation . . . .?” etc.) in order to avoid any misunderstanding or misinterpretation. This is even more important and recommended in cases, where the audit language is not the mother tongue of the auditor and / or auditee or both of them. Only after that, the degree of conformance for the audit evidence with pre-defined audit criteria (e.g. EU GMP part II / ICH Q7 or other) should be assessed as objectively as possible by the auditor (see bullet points hereunder).
- First step: evidence (document, observation)
- Second step: evaluation, confirmation (CAVE: misunderstanding, misinterpretation)
- Third step: documentation
- Fourth step: grading, classification
- Audit report: correct phrasing and reference to audit criteria
The outcome of this evaluation as per each audited item may be conformance, partial conformance or non-conformance. In case of non-conformances a grading / classification into the degree of non-conformance (e.g. “minor / other”, “major”, “critical”) has proven to be useful in order to facilitate the follow-up for the auditor and the auditee. Typically “critical” deficiencies (=non conformances) are rare and subject to severe and systematic GMP violations with potential severe harm to patients’ health. This is often the case for deficiencies found in the manufacturing of sterile APIs or drug products or in case of evidenced data falsification or other fraud actions. “Major” and “minor /other” deficiencies can be distinguished based upon the severity of the GMP violation and / or effect on patients’ health. Often, a “major” deficiency is also justified in cases where the same type of shortfall is recurrently or systematically detected in an audit. Further reference for the classification of audit findings can be derived from the respective definitions provided in the European Medicines Agency (EMA) guideline document “Compliance and Inspection” as referenced at the end of this article.
Do’s and Don’t’s for inspections
As already mentioned earlier, regular inspections of manufacturers by inspectors from NCAs are regarded as important means in Europe to maintain and support the GMP compliance level. The outcome of such inspections for affected companies may be “GMP-compliant” or “GMP-non-compliant” with resulting severe commercial impact in the latter case (e.g. import and / or sales restrictions). What can be recommended as general rules to companies facing official health authority inspections (e.g. EU / US-FDA / EDQM inspections)? How to prepare for such inspections? What to do (and what to avoid) during inspections?
GMP readiness and compliance is expected to be there at all time. Therefore, companies with a constant and high level of GMP-compliance implementation do not need to specifically prepare for upcoming inspections with extra work or efforts. However, preparation of an inspection is meaningful by communication upfront with the inspection team and clarifying any questions concerning e.g. travel & accommodation, inspection date & timing (agenda), inspection scope, translation, areas to be inspected, expected documentation before and during the inspection etc. During the inspection all participating persons from a company should behave open, honest and should clearly communicate in order to maintain an inspection situation of trust and confidence. Any misunderstanding or uncertainty should be clarified as soon as possible. Immediate action on potential deficiencies is often regarded as positive attitude and appreciated by inspectors. The availability of persons, documents / records or areas to be inspected should be taken care of as requested and reasonable, in order to avoid any impression for un-cooperative behavior or unwanted hiding of items / things.
Finally, only those persons being responsible (and thereby knowledgable) should answer only to those questions of the inspectors, which have been asked. It is a good attitude and shows high level of GMP understanding, if a person, who is npt responsible for a certain task does not try to answer (often improperly) but instead points out something like :”Please apologize, this is not my responsibility, therefore it is not me to answer your question, but Mr / Mrs X”. Furthermore an answer should focus on the question rather than to spread out to items, which were not asked.
In the light of an inspection a company is not supposed to do last minute changes and / or reconstructions, unless anyhow required / planned. Any activities suitable to hide items rather than improving and / or solving them are clearly recommended to be avoided, since this may trigger suspicion to the inspectors and move into an unwanted and unsupportive inspection atmosphere. With regard to this, frequently seen things such as interruption of production, painting walls, replacing all kinds of disposable materials (e.g. gaskets, hosepipes etc.), changing / re-newing labels or re-writing documents / records are definitely points, which are not regarded as supportive before and / or during inspections.