| Handling of Audits |
1.0 OBJECTIVE To lay down the procedure for handling of audits. 2.0 SCOPE This procedure is applicable for handling of audits conducted by national and international regulatory audits. 3.0 RESPONSIBILITY • Head/designee-Quality assurance is responsible for managing the audit. • All department Head 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-HR is responsible for hospitality of the auditor and arrangement of their stay and transportation for audit personnel. 4.0 ACCOUNTABILITY Head Quality / QA 5.0 PROCEDURE 5.1 Quality audit is a formal review of a product, manufacturing process, equipment, facilities or system for conformance with cGMP quality standards. 5.2 Audits are defined as mentioned below: 5.2.1 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 5.4 In case of planned audits, which can be either communicated telephonically, mail, letter, senior management shall forward the details of the audit to the Head-QA. 5.5 Head/designee-QA/HR shall prepare the circular, circulate to all concern which contains the information related to audit: Audit information Regulatory authorities Date of audit and duration Product name Name of auditors Audit agenda/Check list if any Scheduling of activities etc. To Read this sop Click here SOP for Operation and Calibration of Fourier Transform Infrared Spectroscopy (FT-IR). 5.6 In case of the audit is not scheduled after reaching the auditor Head-HR shall inform to all department Heads and Head-QA for the arrival of the auditor and guide the auditor to conference room. 5.7 Head-HR shall be responsible for hospitality of the auditor which includes picking, boarding, lodging etc. 5.8 Opening meeting shall be conducted and a brief presentation shall be given by the Plant Head or Head-Quality / QA. Opening meeting shall be attended by Head of QA, Production, QC, store and engineering or others if required. 5.9 Head-QA shall brief the gowning procedure, safety, use of cell phone and other prohibited articles. 5.10 HR or receptionist shall notify all departments for the arrival and during round of the facility to concern department for auditor schedule. 5.11 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 details for final review. 5.12 Copy of the documents if asked during audit shall be submitted through Head-QA. 5.13 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 for audit purpose. 5.14 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. 5.15 If any sample is required to be drawn by auditor Head-QA shall provide necessary information related to applicable procedure and documentation. 5.16 All audit reports and response shall be maintained in QA department and shall be accessed by Head/designee-QA. |
