Procedure For Handling Of Regulatory Audit

admin    |    14-04-2018

procedure for handling of regulatory audit.jpg

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:  Objective of this procedure is to provide a guidance on "How to handle regulatory audit" .

RESPONSIBILITY: Handling of regulatory audit is everyone responsibility who directly involved in the GMP activities; Quality Assurance, Quality Control, Engineering, Manufacturing etc.

PROCEDURE: There are two type of regulatory audit;. (a) Planned audit & (b) unplanned audit.

1. All time readiness is required in case of any unplanned audit & planned audit however if any regulatory authority announce 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.

2. In case of planned audit agenda and scope shall be communicated to the site cross function team who are involve in the inspection. It is better if audit scope / agenda discuss with cross function team personally and decide the way forward with clear action plan or agenda shall be circulate through mail communication. Communication of audit shall be cascade to the sub-ordinate through his/her department head.

3. Quality Head shall lead the inspection and directly coordinate with regulatory auditor.

4. Health declaration form shall be filled by the regulatory auditor before entering to the manufacturing area where auditor can self-declare for any communicable disease as per below format; If visitor does not have any below mention disease then only can enter into manufacturing facility or GMP area.

5. Once the audit agenda shared by the auditor then a site audit team shall be formed who comprise all the Subject matter expert. Apart from the site audit team, one back team shall be formed.

6. One person shall be nominated who received the auditor from gate, once the auditors reach at gate then the nominated person will receive the auditor from gate and will ensure the necessary entry in the respective visitor entry register and escort them up to conference hall or other area.

Opening Meeting

i.                     During opening meeting site head introduce the team (All HOD’s) and present the site presentation to the auditor.

ii.                   During site presentation if any question asks by auditor then respective SME only answer the question.

iii.                 During opening meeting, auditee shall ask the agenda of the day like factory round; facility inspection flow or documents required to review.

Factory round & Document review

(i)                  During factory round, site quality head & plant head shall accompany to the auditor along one scriber who will note down all the question asked by auditor and their answer given by SME (Subject Matter Expert). If any document asks by auditor that also note down by scriber.

(ii)                During factory round, an approved site layout, man- material layout, HVAC zoning layout etc. shall be carried by the auditee.

(iii)               During facility round, if auditor ask any question then respective SME shall only give the answer to the auditor and explain the procedure.

(iv)               All the document ask by auditors shall be arrange by document room back-up team and shall be explain by respective SME’s to the auditor.

(v)                During entire audit arrangement of TEA/Coffee & lunch shall be arrange by the site HR or admin team.

(vi)               If auditor ask copy of any document then “UNCONTROLLED COPY” of the document shall be provide and details of document shall be recorded into respective document control annexure.

(vii)             A list of all the documents (shown to auditors) shall be prepared by the Document Back-up team.

(viii)           Site shall maintain a record of all the regulatory audit with complete details of auditors, regulatory agency, date of audit etc.

Closing meeting

(i)                  During closing meeting, all the HOD shall be available.

(ii)                During audit closing meeting, Quality Head can ask the inspector to give an overview on the observations.

(iii)               If any confusion on the narrated observation then HOD can ask to auditor for further clarification on the observation.

(iv)               After closing meeting all the audit observation shall be narrated to the site audit team for their understanding.

After Inspection

(i)          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.

(ii)         Reply on all the audit observation shall be prepared & communicate within 30 days from the audit report receipt or as per regulatory requirement.

(iii)        CAPA shall be agreed by the respective regulatory authority.

(iv)       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 following things during any regulatory audit

(a) Don't given any volunteer or extra information to the auditor which is not ask by auditor.

(b) Don't give any misleading information to the auditor.

(c) Don't give answer to the auditor without understand the same.

(d) Don't give the answer to the auditor if you are not the SME (subject matter expert) of the question/ area.

(e) 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.



Pharmabuddy    |    14-05-2018

Thank you so much for this informative article. 


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