Regulatory Audit : Preparation & Handling

Standard Operating Procedure (SOP) / Guideline for Preparation and Handling of Regulatory Audit (FDA Inspection) in Pharmaceutical Drug Manufacturing Plant.

Handling of Regulatory Audit (FDA Inspection)


    • The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for Handling the Regulatory Audit.

2.0   SCOPE

    • This SOP shall be used as such for Handling of Regulatory Audit, at Pharmaceutical Drug Manufacturing Plant.


    • Regulatory Audit Coordinator shall be responsible to;

    • Create and maintain an atmosphere of professional and congenial cooperation.
    • Communicate Regulatory Agency about Company intends to comply with all Laws and Regulations.
    • Ensure that comprehensive and accurate notes are taken during the Audit.
    • Regulatory Audit (FDA Inspection) Escort shall be responsible to;

    • Accompany the Auditor during the course of the Audit.
    • Be familiar with the everyday operation of Regulatory Audit, to know who will answer the Auditor Questions, understand legal authority & company’s policies regarding specific situations (signing affidavits), etc.
    • Meet/fulfill Auditor’s needs, guiding to appropriate Subject Matter Experts (SMEs), and communicating internally for Regulatory Audit Progress.
    • Subject Matter Experts (SMEs) shall be responsible to;

    • Be present and participate on request during Regulatory Audit.
    • Answer the Auditor questions for a defined subject.
    • Regulatory Audit Runners shall be responsible to;

    • Locate documents,
    • Coordinate SMEs for participation.
    • Notify the Department Heads when Auditors entering their defined areas.
    • Quality Assurance personnel shall be responsible to;

    • Review and provide inputs to the Audit reports.
    • To review the response and ensure continual compliance through audits.
    • Management Personnel shall be responsible ;

    • To explain the company policy on any denial, where the company is not prepared to provide the information to the Auditor.
    • To identify the personnel for handling Regulatory Audit.


    • Following are the various types of Audits conducted periodically by Regulatory Agencies.
    • Routine Audit (Quality System Audit Technique)

    • Pre-approval Audit for Premarket Approval (PMA):
      • Country-specific Audit procedure for Premarket Approval is available on the website for reference.
    • Follow-up on a warning letter (Violative):
      • The auditor shall be looking for evidence of the company’s compliance with a plan of action made in the response to the warning letter.
    • For-causeAudit (Investigational):
      • Auditors have specific directions for the Audit that is not publicly available.
    • Regulatory Agency intimate well in advance in case of Pre-approval and Routine Audit of the Firm, whereas Investigational & Violative Audit are surprise Audit (without intimations).
    • The agency can ask for Company’s Quality Manual before the start of the Audit.
    • The Management shall identify the following personnel from Site for handling Regulatory Audit:
    • Audit Co-ordinator: Preferably Senior person from the Site.
    • Audit Escort: Person who accompanies during the course of Audit even in absence of the Audit Co-ordinator.
    • Management Personnel: High Ranking personnel at the site /Organization to explain the Company Policy (need-based).
    • Subject Matter Experts (SMEs): Functional Department Heads / Doers. SMEs are trained for the types of questions that are likely to be asked by the Auditor for their areas of expertise.
    • Audit Runners: Person aware / understand the Audit process.
  • Receiving Regulatory Agency Personnel (Auditor):

    • The receptionist shall be trained for the Auditors arrival.
    • Considering the Audit during non-office hours, the training needs to be imparted to Security Guard / Supervisor as applicable.
    • The receptionist shall notify the most responsible person i.e. Audit Coordinator and Audit Escort on the arrival of the Auditor at the Facility.
    • The Receptionist shall ask the Auditors to Sign the Visitors’ Log and wear a visitor badge. (as applicable)
    • The audit Coordinator shall guide them to a designated conference room or office for the entire time of the Audit.
    • The audit Coordinator shall accompany the Auditor during the course of the Audit.
  • Initial Meeting with the Auditor:

    • The audit Coordinator shall meet and introduce himself to the Auditor.
    • Generally, Auditor introduces themselves covering the following information:
      • The Name of the Auditor
      • The credentials of the Auditor
      • The purpose of the visit
    • If the purpose of the visit is for a Routine (Facility) Audit, the Auditor should issue a Notice of Audit.
    • Attendance Record for Opening and Closing Meeting as per Attachment-01 to be filled and maintained along with Audit Report by QA.
    • As appropriate, the Audit Coordinator shall introduce the Audit Escort to Auditor and explain the role of the Audit Escort.
    • Request that the Auditor shall direct all company-related questions to the Audit Coordinator.
    • Audit Escort shall be asked to alert the Audit Coordinator if there are any issues the Auditor wants to discuss.
    • Audit Coordinator shall notify each of the following Company Department Heads that an Auditors is on Company premises:

      • Warehouse,Regulatory Audit Guideline
      • Engineering,
      • Manufacturing,
      • Quality Control,
      • Quality Assurance and
      • Human Resources etc.
    • Audit Coordinator or his deputed person shall give the brief presentation regarding the Nature of company business. (But not limited to):
      • Overview of Company Infrastructure
      • Company Quality Management System
      • Product List
      • Company Organization Chart
      • Total Number of Company Employees and Facility
    • Inform the Auditor about the company administration aspects like Lunch Room / Wash Room / Rest Room etc. available in the near vicinity of the seating arrangement.
    • The auditor should be informed about the Company policy with respect to Ornaments, Photography, and Mobile.

Related : SOP & Checklist – Internal Audit (Self Inspection)

    • If the Regulatory Audit is expected to extend more than 2 days, develop an agenda to facilitate a timely and efficient Regulatory Audit and to assure that key personnel is available for consultation.
    • The audit Coordinator shall decide whether or not other blocks/site personnel are required to participate in the Regulatory Audit.
    • Avoid allowing non-essential personnel to be drawn into conversations unless specifically requested.

    • Audit Co-ordinator and Escort shall create and maintain an atmosphere of professional and congenial cooperation.
    • The Audit Coordinator shall seek to resolve the difficult matter as quickly as possible so as to preserve a good working relationship with the Auditor.
    • The audit Coordinator shall allow Department Heads (SMEs) or other personnel to answer the questions but only upon a determination that a particular person is appropriate to respond.
    • The audit Coordinator may facilitate the answering if needed.
    • While responding to Auditors Questions / Query following is to be considered:

      • The relevant portfolio holder or Functional Head is responsible for answering the question.
      • Understand the question in totality and seek clarification if you are not sure of the question’s meaning. Ask for explanations if necessary.
      • Answer the questions in audible voice taking care of necessary grammatical poses and space between two words for ease of understanding of Auditors.
      • Refer to the written procedure (if needed) during answering the question.
      • Answer the questions that are within the area of your responsibility and expertise.
      • If the Auditors question is not related to the area of operation inform Inspectto and direct them to appropriate SMEs.
    • Audit Co-ordinator / Escort shall ensure their / deputy presence during the entire course of Audit including walk-around of Facility in case of more than one Auditor.
    • The Auditor may be left alone to review documents that they have collected, although the Audit Co-ordinator should remain conveniently available to Auditor during the review in order to answer any questions that may arise.
    • If the Audit Coordinator or Department head believes that a question is argumentative or inappropriate, the escort shall ask the Auditor to clarify or rephrase the question.
    • During the course of the Regulatory Audit, the Auditor may identify a condition that merits correction.

    • If proper correction can be made, then remedial action should be taken immediately during the Regulatory Audit.
    • Even so, however, this remedial action may not prevent the mention of the condition on the Agency list of Regulatory Audit observations.
    • However, the remedial action should be implemented and documented.
    • The Auditor should be facilitated to note the correction of the condition on the Regulatory Audit Report if not on the observation.
    • The Regulatory Audit Coordinator shall take detailed notes during the visit.
    • All notes shall be recorded, be factual, accurate, and without opinion.
    • Record all the documents and files that are reviewed by the Auditor.
    • The auditor shall be given adequate time to review these documents.
    • Identify all the items that require follow-up during the investigation.
    • Release only single copies of documents to the Auditor.
    • A copy of each document released to the Inspector shall be checked prior to release.

    • A set of documents/evidence (eg. labels and labeling, product labels, inserts, promotional literature and advertising materials, samples of components, in-process materials, and/or finished products) collected by the Auditor shall be released however the second set of documentation shall be retained.
    • If samples are released to the Regulatory Audit agency, the Audit Co-ordinator shall request to the Auditor that the company be provided sample analysis results when those results are available.
  • Regulatory Audit Conclusion:

    • After the Regulatory Audit, the Auditor shall conduct an exit discussion (closing meeting).
    • The closing meeting shall be attended by the Audit Co-ordinator, Audit Escort, and those responsible for taking corrective actions i.e Subject matter experts.
    • During this closing meeting that the Auditor may provide a written list of significant observations.
    • The auditor may also orally detail less significant observations during the meeting.
    • For each written observation, make sure the company understands the observation. If not, ask for clarification.
    • Following to be considered during the closing meeting of Regulatory Audit:

    • If agree with the observation, and corrective action has been determined, explain the Auditor’s course of action.
    • If agree with the observation, but do not know what the correction will be yet, say so.
    • I do not agree with the observation, explain the concern and discuss it with the Auditor.
    • For each oral observation, make sure it is understood properly and have an employee make a note so it can be considered for corrective action after the meeting is over.
    • Audit Escort shall facilitate the Auditor for any assistance required regarding their schedule after the closure of the day’s Regulatory Audit.
    • At the end of the complete RegulatoryAudit, the Audit Coordinator shall present a vote of thanks on behalf of the site and organization to the Auditors.

    • The audit Coordinator shall also demonstrate a positive approach towards furnishing the compliance and assuring continual improvement.
    • Audit Escort shall facilitate the Auditor for any assistance / accompany for their onward journey to their destination.
    • Before the closing meeting, The findings shall be shared and circulated through email to Plant Head, QA Head, Regulatory Compliance Head, and concerned seniors by the Audit coordinator.
    • Audit Co-ordinator with the co-operation and inputs of all relevant company personnel (Department Heads / SMEs), shall be responsible for authoring and preparing any and all written responses and other related subsequent correspondence to the observations.
    • The same shall be forwarded to QA Head and Regulatory Compliance Head for their review and inputs.
    • After incorporating the inputs appropriately, the written response directed to the Regulatory Agency should be submitted as per the Regulatory Agency requirement on receipt of the Regulatory Audit Report.
    • The written response shall be a point-by-point response to the items identified on observations.
    • The response should address broad-ranging quality and compliance issues, not just the specific item mentioned in the observations.
    • The written response shall be professional, non-argumentive as appropriate. Only written correspondence shall be provided in response to observation.
    • The response shall address the following:

    • An explanation of any matters the Auditor included on the observation, but which the company does not intend to change.
    • A description of changes that have been implemented.
    • A description of changes currently being implemented, with an estimated date of completion. (TCD)
    • An identification of any unclear observations


Attachment 1 – List of Personnel present during Opening and Closing Meeting

Name of Regulatory Agency  
Name of Auditors  
Audit Schedule From : To :


Name Designation Signature with Date
Opening Meeting Closing Meeting



    • Audit Coordinator:

    • The Audit Coordinator is the Company personnel assigned to accompany the Auditor during the course of the Audit. Responsible for ensuring that the Company Policy reflected in this guideline is adhered to and followed, and for ensuring that comprehensive and accurate notes are taken during the Audit.
    • Audit Escort:

    • Audit Escort is the company personnel assigned to accompany the Auditor during the course of the Audit, in the event, that there is more than one Auditor.
    • The role of Audit Escort is to act as a ‘hall monitor’ or chaperon, to ensure that the Auditors shall not be left unattended during their presence at the Site, and to direct all company-related questions that the inspector may have to the Inspection Coordinator.
    • In the immediate absence of the Inspection Co-ordinator, the Inspection Escort is responsible for taking comprehensive and accurate notes as necessary.
    • Subject Matter Experts:

    • Subject matter experts are the company personnel expert in their work area who needs to answer the Auditor questions for the defined subject when required.


Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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