SOP for Handling of Audits

This Document describes (Standard Operating procedure) SOP for procedure for handling of audits.

SOP for Handling of  Audits

OBJECTIVE :

To lay down the procedure for handling of quality audits.

SCOPE

This procedure is applicable for all customers, regulatory audits conducted at site.

This procedure does not apply to financial or fiscal audits.

RESPONSIBILITY :

• Head/designee-QA is responsible for scheduling and managing the audit.
• All department Heads are responsible for maintaining their areas and keeping all documents with ease of retrieval when required and answering to the questions asked by the auditor(s).
• Head/designee-P&A is responsible for hospitality of the auditor(s).

ACCOUNTABILITY :

Head Quality / QA

PROCEDURE :

Quality audit is a formal review of a product, manufacturing process, equipment, facilities or system for conformance with cGMP quality standards.

Audits are defined as mentioned below:

Customer Audit:

• An independent examination of quality system’s compliance with recognized, accepted standards and policies by a customer and/or a third party representing the customer.

Prospective and existing :

• Regulatory Audit-National/International Drug Regulatory Authorities: An independent examination of certain parts or all of quality system made to determine compliance with government or other recognized agency’s regulations.
• Local FDA
• WHO ( State and Central)
• EU / US / Other countries (agencies)
• ISO
• Marketing department/corporate office shall notify the details of any external agency inspection of the site to the Head QA. Details shall include: Name of agency, Inspection dates, Name and designation (s) of the auditors, Purpose of inspection.
• In case of planned audits, which can be either communicated telephonically, mail, letter marketing/senior management shall forward the details of the audit to the Head-QA.
• Head/designee-QA/P&A shall prepare the circular, circulate to all concern which contains the information related to audit:
• Audit information
• Customer
• Regulatory authorities
• Date of audit and duration
• Nature of audit: Preliminary/surveillance/ product approval/ quality systems/facility approval etc.
• Product name
• Name of auditors
• Audit agenda/Check list if any
• Scheduling of activities etc.
• Head/designee-QA shall define “Escort” who takes detailed notes during the audit (if required).
• In case of the audit is not scheduled after reaching the auditor Head-P&A shall inform to all department Heads and Head-QA for the arrival of the auditor and guide the auditor to conference room.
• Head-P&A shall be responsible for hospitality of the auditor which includes picking, boarding, lodging etc. asked by the auditors as permitted by law and company policy.
• Opening meeting shall be conducted and a brief presentation shall be given by the Plant Head or Head-QA. Opening meeting shall be attended by Head-QA, Production, QC or others if required.
• Head-QA shall brief the gowning procedure, safety, use of cell phone and other prohibited articles.
• HR or receptionist shall notify all departments for the arrival and during round of the facility to concern department for auditor schedule.
• After the presentation as per the audit agenda scheduling to be done. All the Heads/designee shall be present during audit in their respective department. Documents shall be presented in systematic manner and answers shall be given for the questions asked only.
• During documentation review all documents shall be presented to the auditors for any point of discussion is required it shall be discussed at the last of audit. All the observations shall be noted in detail.
• Copy of the documents if asked during audit shall be submitted through Head-QA.
• Confidential documents which are private and proprietary in nature will not be made available however a summary or extract can be made available such as internal audit reports, Other audit reports, technology transfer documents received from customer which have confidentiality clause for non-disclosing of information.
• During plant visit only Head-QA and concern department Heads shall accompany if required other person shall join but person shall be restricted to minimum as felt by Head-QA.
• If any sample is required to be drawn by auditor Head-QA shall provide necessary information related to applicable procedure and documentation.
• After completion of the audit all the documents shall be archived in their respective place. Internal discussion shall be done and compliance to the observation shall be presented to auditor for closure of observation.
• Photographs if required to be taken by auditor due authorization from the Director permission/Head-QA shall be obtained.
• Closing meeting shall be attended by all functional department Heads and summary report prepared by auditors shall be noted if required. Discussion can be done with auditors in gentle manner and shall not lead to an argument. All the explanation shall be given by the respective persons and shall not be interrupted by others.
• Audit report or any notification issued by the auditor shall be received by either Plant Head/Director or Head-QA on behalf of the company.
• After receiving the audit report if any non conformance or suggestions made shall be discussed between the all department concern personnel and CAPA shall be planned with target date of completion. A response for the target date with CAPA planned shall be sent to Head-QA for review and authorization before implementation.
• After the authorization Head-QA shall follow-up for the compliance and implementation. Head-QA shall prepare the compliance report along with all supporting documents. Compliance report shall be sent to auditor within 30 working days after receiving the formal audit report from auditor or as per the auditing agency requirement.
• All audit reports and response shall be maintained in QA department and shall be accessed by Head/designee-QA.

ABBREVIATIONS :