Planning and Procedure followed During Regulatory Audits : Pharmaguideline

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Planning and Procedure followed During Regulatory Audits

Planning for regulatory audits including step-by-step procedure followed during audit including instructions.
Different types of inspections are conducted by Regulatory Agencies. Following are the various types of inspections conducted periodically by Regulatory Agencies.

1 Routine Inspection: Quality System Inspection
2. Pre-approval Inspection for Pre-market Approval (PMA): Country-specific inspections
3. Follow-up on a warning letter (Violation): Inspector will look for evidence of the company's compliance with a plan of action made in the response to the warning letter.
4. For-cause Inspection (Investigational): Inspectors have specific directions for the inspection that is not publicly available. 

Regulatory Audit Plan:

In case of pre-approval and routine inspection of the firm, Regulatory Agency will intimate well in advance whereas investigational & violation inspection is without intimations. These are surprise inspections. Before the start of the inspection, the agency can ask for company's Quality Manual. Management has to identify the following personnel for handling Regulatory Audits:
    Procedure for Audits
  • Inspection Coordinator: a preferably senior person from the site.
  • Inspection Escort: Person who accompany during the course of inspection even in absence of inspection coordinator.
  • Management Personnel: High ranking personnel in the 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 inspector for their areas of expertise. 
  • Inspection Runners: Person aware / understand the inspection process.
  • Give proper training to the receptionist or any other person for receiving of Regulatory Agency Personnel (Inspector). Considering the inspection during nonoffice hours, the training needs to be imparted to security guard/supervisor as applicable.

Auditing Procedure:

The most responsible person i.e. inspection coordinator and inspection escort are informed immediately about the arrival of inspectors. Inspectors are asked to sign the visitor's log and wear a visitor badge or inspector badge. Inspection coordinator will guide inspectors to a designated conference room or office for the entire time of inspection. Inspection coordinator will accompany the inspector during the course of the regulatory audit. In case of initial meeting with the inspector, there will be a brief introduction of all the members. Generally, inspector introduces them covering following information:
  • The name of the inspector
  • The credentials of the inspector
  • The purpose of the visit

If the purpose of the visit is for routine (facility) inspection, the inspector will issue a notice of inspection. Fill attendance record for opening and closing meeting and maintain along with inspection report. At the time of introduction request that all company related questions to be asked to the inspection coordinator. Inform all department heads that inspectors is on company premises.

  • Give brief presentation regarding the nature of company business. 
  • Overview of company infrastructure
  • Company quality management system
  • Product list
  • Company organization chart
  • Total number of company employees and facility

Inform the inspector about the administrative aspects of lunchroom/washroom/restroom etc. available in the near vicinity of the seating arrangement. Inspector should be informed about the company policy with respect to ornaments, photography and mobile. If the inspection is expected to extend more than 2 days, develop an agenda to facilitate a timely and efficient inspection and to assure that key personnel is available for consultation. Avoid allowing non-essential personnel to be drawn into conversations unless specifically requested.

Create and maintain an atmosphere of professional and congenial cooperation. Matters must be resolved as quickly as possible so as to preserve a good working relationship with the inspector. The relevant portfolio holder or functional head is responsible for answering the question. Understand the question in totality; seek clarification if you are not sure of the meaning of the question. 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 inspectors.

Refer the written procedure (if needed) during answering the question. If the inspector's question is not related to the area of operation inform Inspectors so and direct them to appropriate subject matter experts (SMEs). Accompany during the entire course of inspection including walk around of facility. Leave the inspector alone to review documents that they have collected, although the inspection coordinator should remain conveniently available to the inspector during the review in order to answer any questions that may arise. If the inspection coordinator or department heads believe that a question is argumentative or inappropriate, the escorts can ask the inspector to clarify or rephrase the question.

During the course of the inspection, the inspector may identify a condition that merits correction. If the proper correction can be made, then remedial action should be taken immediately during the inspection. Even so, however, this remedial action may not prevent the mention of the condition on the agency list of inspections observations.

However, the remedial action should be implemented and documented. The inspector should be facilitated to note the correction of the condition on the inspection report if not on the observation. Record detailed notes during the visit. Be factual, accurate and without opinion, while the recording of notes. Record all the documents and files that are reviewed by the Inspector. Give adequate time to the inspector to review these documents. Identify on all the items that require follow-up during the investigation. 

At the conclusion of the inspection, the inspector will conduct an exit discussion (closing meeting). The closing meeting must be attended by inspection coordinator, Inspection escort and those responsible for taking corrective actions i.e subject matter experts. For each written observation, make sure to understand the observation. If not, ask for clarification. If agree with the observation, and corrective action has been determined, explain the inspector course of action. If agree with the observation, but do not know what the correction will be yet, say so. If do not agree with the observation, explain the concern and discuss it with the inspector.

For each oral observation, make sure it is understood properly and make a note so it can be considered for corrective action after the meeting is over. Facilitate the inspector for any assistance required regarding their schedule after the closure of day's inspection. The present vote of thanks to the inspectors at the end of the complete inspection.

Demonstrate a positive approach towards furnishing the compliance and ensuring continual improvement. Inspection coordinator with the cooperation and inputs of all relevant personnel (Department Heads / SMEs) is responsible for authoring and preparing any and all written responses and other related subsequent correspondence to the observations. 

After incorporating the inputs appropriately, submit the written response as per the Regulatory Agency requirement on receipt of the inspection report. Give point-by-point response to the items identified on observations, address broad-ranging quality and compliance issues, not just the specific item mentioned in the observations, be professional, businesslike, non- argumentative and appropriate.

In response to observation provide only written correspondence. Give an explanation of any matter the inspector included, but which you do not intend to change, description of changes which have been implemented, a description of changes currently being implemented, with an estimated date of completion.
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