SOP on handling of Regulatory Audit
From the business point of view every regulatory audit is important for any pharmaceutical facility and handling of regulatory audit is an art and its required lots of preparation so go through below details to handle regulatory audit effectively and there must be a procedure in every pharmaceutical industry to handle the audit.
OBJECTIVE: The objective of this procedure is to provide guidance on “How to handle regulatory audit” .
RESPONSIBILITY: Handling of a regulatory audit is everyone’s responsibility who directly involved in the GMP activities; Quality Assurance, Quality Control, Engineering, Manufacturing, etc.
PROCEDURE: There are two types of regulatory audits;. (a) Planned audit & (b) unplanned audit.
- All-time readiness is required in case of any unplanned audit & planned audit however if any regulatory authority announces site audit in an unplanned manner then fast communication to the team is very much essential to gather all the documents as per regulatory authority requirement.
- In case of planned audit agenda and scope shall be communicated to the site cross-function team who are involved in the inspection. It is better if audit scope/agenda discuss with the cross-function team personally and decide the way forward with clear action plan or agenda shall be circulated through mail communication. Communication of audit shall be cascade to the sub-ordinate through his/her department head.
- Quality Head shall lead the inspection and directly coordinate with the regulatory auditor.
- Health declaration form shall be filled by the regulatory auditor before entering the manufacturing area where the auditor can self-declare for any communicable disease as per the below format; If a visitor does not have any below mention disease then only can enter into manufacturing facility or GMP area.
- Once the audit agenda shared by the auditor then a site audit team shall be formed who comprise all the Subject matter experts. Apart from the site audit team, one back team shall be formed.
- One person shall be nominated who received the auditor from the gate, once the auditors reach at the gate then the nominated person will receive the auditor from the gate and will ensure the necessary entry in the respective visitor entry register and escort them up to the conference hall or another area.
- During the opening meeting, site head introduces the team (All HOD’s) and presents the site presentation to the auditor.
- During site presentation, if any question asks by auditor then respective SME only answers the question.
iii. During the opening meetings, auditee shall ask the agenda of the day like factory round; facility inspection flow, or documents required to review.
Factory round & Document review
- During factory round, site quality head & plant head shall accompany the auditor along one scriber who will note down all the questions asked by the auditor and their answer is given by SME (Subject Matter Expert). If any document asks by the auditor that also note down by scriber.
- During factory round, an approved site layout, man- material layout, HVAC zoning layout, etc. shall be carried by the auditee.
- During facility round, if the auditor asks any question then the respective SME shall only give the answer to the auditor and explain the procedure.
- All the documents ask by auditors shall be arranged by the document room back-up team and shall be explained by respective SMEs to the auditor.
- During the entire audit arrangement of TEA/Coffee & lunch shall be arranged by the site HR or admin team.
- If the auditor asks a copy of any document then “UNCONTROLLED COPY” of the document shall be provided and details of the document shall be recorded into respective document control annexure.
- A list of all the documents (shown to auditors) shall be prepared by the Document Back-up team.
- The site shall maintain a record of all the regulatory audit with complete details of auditors, regulatory agency, date of audit, etc.
- During the closing meeting, all the HOD shall be available.
- During the audit closing meeting, Quality Head can ask the inspector to give an overview of the observations.
- If any confusion on the narrated observation then HOD can ask to the auditor for further clarification on the observation.
- After closing the meeting all the audit observations shall be narrated to the site audit team for their understanding.
- Once the audit report received then a suitable reply or CAPA to be prepared by the Site quality team along with cross-functional department SME & HOD.
- Reply on all the audit observation shall be prepared & communicate within 30 days from the audit report receipt or as per regulatory requirement.
- CAPA shall be agreed by the respective regulatory authority.
- All the evidence of action completion shall be shared with the respective regulatory authority/ auditor and ask any feedback on the closure report (CAPA report).
Note: Avoid the following things during any regulatory audit
Don't give any volunteer or extra information to the auditor which is not asked by the auditor.
Don't give any misleading information to the auditor.
Don't give an answer to the auditor without understanding the same.
Don't give the answer to the auditor if you are not the SME (subject matter expert) of the question/ area.
Don't be panic during inspection otherwise, it will impact the team spirit and this panic situation create a doubt in the auditor's mind so avoid it.