Audit of Pharmaceutical Plant By External Auditors

Procedure :

Intimation / Conformation of Inspection :

  • Intimation for the inspection from Regulatory Authority shall be received by Corporate Office and shall be communicated to Unit Head and or Quality Head of the respective site or location.
  • The confirmation for the inspection programme with Regulatory Authorities should be done by Corporate Quality Assurance.
  • The itinerary and staying of Inspector (s) during inspection should be arranged by Corporate Office or Plant Administration Department of the respective site or location.

Co-ordination :

  • The Inspector(s) appointment to conduct the inspection should be accompanied from the Hotel/Airport to the location by a company representative.
  • On reaching the unit, the Inspector (s) should be taken to the conference room where they should be introduced to the entire concerned department Heads.
  • After the introduction, presentation should be made by the Unit Head/Quality Head which include about organization, Product, Plant layout and approvals etc.
  • The Unit Head/Quality Head should present the Site Master File, if required to the Inspector and brief him/her of the activities at the site.

Answering of Questions during Inspection or Audit :

  • Any questions raised by the Inspector(s) should be answered either by Unit Head / Quality Head.
  • In case further clarification is required the respective department head should be called to answer the query.
  • In case the Inspector(s) desire to ask question to any other person the respective Department Head should call a responsible department person to answer the query.
  • The respective department person who has done the activity or the doer shall also responsible to answer or explain to the Inspector if asked by him/her.

Provision of Documents and Records :

  • The documents asked by the auditor shall be available without delay.
  • The subject matter expert or the doer of the respective department shall be responsible to explain the documents to the auditor.
  • In case the Inspector(s) desire to check any document / records, that would be provided either by Respective Department Heads / QA-Head / Unit Head.

Tour of the facility :

  • The Inspector(s) may split and start audit in more than one departments at the same time with or without audit agenda or intimation.
  • The Inspector(s) should be accompanied by the Unit Head /Quality Head during the tour of the facility.
  • The respective department head should join them when they arrive at the department.
  • The Inspector(s) shall accompanied or guided by the respective department head before entering to the change room.

Response to any non-compliance during Audit :

  • In case any point of non – compliance is made by the Inspector(s), the same should be addressed on top priority by the QA-Head / Unit Head for corrective action.
  • Non compliance should be addressed immediately or within the time frame of respective statutory authority.
  • Non compliance which are addressed immediately shall be shown to the inspectors in the closing meeting.
  • Follow up on above should be done till all points are compiled with and firm response should be sent.
  • Site is applicable to inspection for any working days within 8:30 to 17:30 (Except Holiday / Weekly Off). If required audit can be planned with prior authorization of Unit Head and or Quality Head.
  • Photographs /video shooting within company premises are not allowed (If required prior permission of Unit Head / Quality Head shall be taken.)
  • Related Topic

Conclusion :

When is someone ready for the inspection the following questions may be useful as follows :

  • Have you identified, evaluated and tackled all internal and potential compliance risks.
  • Are you aware of the current inspection trends and possible focuses specially related to your product.
  • Have you informed and prepared all the colleagues involved and are all the roles clearly assigned.
  • Are you sure that all your colleagues are competent enough to answer the inspectors’ questions and provide clear information about the processes and documentation.
  • Have you established procedures about how to handle the inspection and answer the inspectors’ questions .

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