SOP for Audit Handling procedure

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OBJECTIVE : To describe a procedure to ensure an all-time audit preparedness, so that every audit is managed successfully and all post audit actions are completed effectively to close audit observations, if any.

SCOPE : This SOP shall be applicable to all departments of (Company Name).

RESPONSIBILITY
Functional Heads of all departments shall be responsible to ensure that activities are performed in line with laid down procedures and practices. They shall also be responsible to provide appropriate action plans to the audit observations.
Head, Quality or designee shall be responsible to lead the team for any audit by external agencies, customers or local regulatory authorities.
Manager Quality Assurance (QA) shall be responsible to collate all the post audit actions that are planned and submit the final report to Head Quality or designee for forwarding to the external agency, customer or local regulatory authority.
Manager QA or designee shall be responsible for evaluating the effectiveness of the post audit actions that are put in place.

ACCOUNTABILITY Head of Quality

PRECAUTIONS NA

PROCEDURE
6.1 Categories of Audit
6.1.1 There are majorly four categories of audits. They are listed below.
6.1.2 Audits conducted by Local Regulatory Authorities
6.1.2.1 This audit involves an assessment of (Company Name) quality systems, manufacturing and control processes in the following circumstances:
 At an interval of every two years for the renewal of manufacturing license.
 Any other specific reason as required by the local regulatory authorities.

6.1.3 Audits conducted by External Regulatory Agencies
6.1.3.1 This audit involves a detailed assessment of (Company Name) quality systems, manufacturing and control processes by external agencies such as WHO, UNICEF, GCC, TGA, MHRA, US FDA, ANVISA, any EU or African member state authorities, or any other external agencies attached to the ministry of health for various countries across the globe.
6.1.3.2 This audit is conducted periodically by various agencies mentioned in step 6.1.3.1 depending on their need to audit (Company Name), and their frequency to ensure adherence to cGMP and other relevant guidelines.
6.1.4 Audits conducted by Contract Givers or Customers
6.1.4.1 This audit involves a detailed assessment of (Company Name) quality systems, manufacturing and control processes by other organizations, for whom (Company Name) manufactures products as a third party manufacturer.
6.1.4.2 This audit is conducted periodically by contract givers or customers as per their frequency and need to review adherence to cGMP and other relevant guidelines by (Company Name) while manufacturing their products.
6.1.5 Self-Inspection conducted by Site team
6.1.5.1 This audit involves an internal assessment of quality systems and procedures prevalent at (Company Name) to establish an effective cGMP system with an aim to continual improvement.
6.2 Scheduling and planning audits
6.2.1 Audit by Local Authorities /External Regulatory Agencies/ Customers
6.2.1.1 Usually, Head, Quality or Head, Regulatory Affairs receives the audit schedule mentioning the date/s and timing of the audit from the local regulatory authority/other external regulatory agencies or customers.
6.2.1.2 Head, Quality or Head, Regulatory Affairs will inform functional heads of all concerned departments including Head of Domestic and International Marketing (as applicable), along with the following personnel through an e-mail communication, about the received audit intimation.
 Managing Director
 Chief Operating Officer
 Chief Financial Officer
 Director, Commercial

6.2.1.3 Head, Quality or designee will arrange a meeting with all stake holders and relevant employees to review the audit handling process.
6.2.1.4 Head Quality and Head Manufacturing will organize and co-ordinate the audit.
6.2.2 Self-inspection
6.2.2.1 Self-inspection will be conducted twice in a year as per SOP NO. QA012 on ‘Self-Inspection’.
6.2.2.2 Subject matter experts from various departments are identified by Head Quality, depending on their expertise and their completion of the requisite training and provided requisite information about the conduct of self-inspection as per the cGMP guidelines of various regulatory agencies.
6.2.2.3 Depending on the previous experience of the selected individual, the training topics may include, but not limited to, overview of quality objectives, objective of the quality audit, Do’s and Don’ts for auditors, conversation and interview techniques to be adopted when on floor walk, reporting mechanisms of findings, and evaluation of CAPA when implemented.
6.2.2.4 The subject matter experts identified and trained on auditing shall conduct the self-inspection in a free and fair manner and suggest observations to improve the quality systems.
6.2.2.5 The audit team for a specific department shall include members except the individual selected from the department being audited.
6.2.2.6 Self-inspection shall be conducted against the following procedures and practices:
 Quality Policy
 Current GMP and quality standards
 Standard Operating Procedures
 Regulatory requirements
 Facilities and utilities design requirements
 Previous audit recommendations

6.3 Team members during audit
6.3.1 During the audit by local regulatory authority, external regulatory agency or customers, Head Quality, Head Manufacturing and Head Regulatory Affairs, as applicable shall accompany the auditors/ inspectors, to the various departments.
6.3.2 Functional heads of different departments or their designees shall provide the requested information and answer queries posted by the auditors/ inspectors within their department.
6.3.3 If a wrap up meeting of the day’s audit / inspection is being held by the auditor / inspector, all functional heads of department audited on that day shall be present.

6.4 Pre-Audit Preparation
6.4.1 Review the following critical documents from a status update perspective on the announcement of an audit. The list given below is only indicative and can include all other relevant documents of the Quality management system.
 Water system
 Calibration and preventive maintenance activities
 Deviation, Incident, OOT, OOS, records and relevant CAPA considerations
 Product /Market complaint system and follow up
 Validation and revalidation status
 Document control
 Change control
 Material handling
 Product quality review
 Training records
 Computer access and security
 Computer system validation

6.4.2 Potential areas of risk which may include but not limited to ones listed below must be reviewed on an ongoing basis.
 Atypical product quality complaints
 Batch review performance
 Recurring GMP deviations and incidents
 Departmental self-audits
 Critical system health checks-Overdue SOPs and Master Lists
 Health checks on correct use and robustness of systems
 General housekeeping
 Facility fabric and services health checks
 Rodent control
 Health checkup of personnel involved in routine inspection of products

6.5 Preparation for the Audit and management plan
6.5.1 Preparations must be carefully planned and well organized to ensure a successful audit. The plan includes the following:
 Terms of reference for audit
 Names and backgrounds of auditors
 Cultural considerations
 Escort team in different areas

6.5.2 The escort team will be formed from the following members
 Head of Quality
 Head of Manufacturing
 Head of Regulatory Affairs

6.5.3 The various roles during the audit / inspection shall be as under. These are only indicative and roles can be changed or additional roles can be defined, based on number of auditors, audit areas, cultural considerations etc.
 Team leader – Head of Quality.
 Note takers – Head of Quality and Head of functions audited.
 Runners

6.5.4 The following personnel from various departments shall be on a standby for relaying any relevant information to the personnel being questioned by the auditor/ Inspector.
 Regulatory Affairs Department – Senior Officer, Regulatory Affairs
 Quality Assurance Department – Senior Officer, QA and Validation
 Production Department – Senior Officer, Production
 Warehouse Department – Senior Officer, Warehouse

6.5.5 The following personnel from various department shall be appointed as finders to locate requested documents within the shortest possible period of time.
 Senior Officer, Production
 Senior Officer, Quality Assurance
 Senior Officer, Engineering
 Senior Officer, Training
 Senior Officer-Validation

6.5.6 Additional plans will include
 Factory/ site tour
 Human Resources Management head shall be responsible to ensure the hotel and ground transportation arrangements, if requested for.
 Human Resources Management head shall also be responsible to make arrangements for social programs, if requested.

6.5.7 Head, Quality Head Manufacturing and Head Regulatory Affairs will ensure the following:
 Opening Presentation, List of attendees for the opening introductions with auditors/ inspectors
 Room organization and preparation.
 Number of audit rooms and control rooms required.
 Computer systems and printer support
 White boards, Stationary etc. in the audit room
 List of documents requested by the auditor prior to audit commencement, if applicable
 Documentation and monitoring logs to ensure documents requested by auditors/ inspectors are brought to audit room and then returned to their respective owners after review.

6.5.8 Other points that are worth considering for a successful audit would include:
 An effective communication plan to ensure that the correct information regarding the progress of the audit is communicated to all staff at the right time.
 Relevant staff including audit management team, technical experts, and operators must be trained on the audit management process which might include
o Description of the audit process
o Description of how audits are managed
o Audit conduct and protocol
o Areas of risk
o Question sequence
o Rules of answering questions
o Phrases to avoid
o Do’s and Don’ts
o Body language when answering the auditors/ Inspectors
o Behavior and personal conduct

6.6 During the audit
6.6.1 Provide the auditor with an information pack, consisting of
 Organization charts
 Schematics of major equipment
 Agreed agenda and time table
 Transport arrangements
 Office timings
 Any other social activities, if requested
 Any other information requested prior to the audit

6.6.2 Following must be ensured by the escort team during the audit:
 Functional department managers are available in their respective departments with relevant supervisors at the scheduled time of auditor’s tour in their department.
 Always have a ‘scout’ on the floor who is ahead of the ‘audit team’ to make the staff aware of the auditor’s location.
 Whilst on the site tour, the escort team must have at least one ‘runner’ that can be used to call-in technical experts if required for an on spot explanation.
 Take crisp but accurate notes during the site tour throughout the audit. These are essential for determining the exact context from which the auditor identifies any non-conformance.

6.6.3 Head, Quality shall brief the management team at the end of each day about the following
 Auditors considerations
o Definite ‘Write –Ups’ or observations
o Immediate corrective actions that can be initiated to close a confirmed observation prior to wrap –up day
o Minor observations that most probably will not be cited in the report
o Auditor’s feel and impression about the organization
o Availability of documents/ information to the auditor

 Control room problems
o Is an effective communication being maintained between ‘Finders’, ‘Runners’, and the ‘Technical experts’?
o Has there been any difficulty in contacting people or retrieving documents?
o What was done perfectly well?
o What went wrong and can be done better?

6.7 Audit reporting and action plan
6.7.1 Usually, Head, Quality or Head, Regulatory Affairs receives the audit report with the observations from the local regulatory authority/other external regulatory agencies or customers.
6.7.2 Head, Quality or Regulatory Affairs will share the audit report to relevant stake holders and instruct QA manager or designee to follow up for a consolidated CAPA plan.
6.7.3 On receipt of the audit report, the relevant stakeholders in coordination with Manager QA shall prepare a CAPA response against each observation and comment.
6.7.4 Head of Quality and Head of Manufacturing will finalize the CAPA before it is shared with concerned auditors of local regulatory authority/other external regulatory agencies or customers.
6.7.5 Head Quality or Head Regulatory Affairs will forward the CAPA to the respective auditors of local regulatory authority/other external regulatory agencies or customers.
6.7.6 Manager QA will completely review the commitments, recommendations and responsibility assigned in the final audit report.
6.7.7 Manager QA or designee will monitor the progress of the corrective and preventive action plan on a regular basis.
6.7.8 A follow-up review or audit must be conducted by a team designated by Head Quality or Head regulatory Affairs to confirm the effectiveness and documentation of the CAPA plans.
6.7.9 All audit reports and self-inspection reports must be reviewed in the Quality Council meeting.
6.8 Tools of corrective action management
 Audit progress report.
 Site quality forum (Site Quality Council meeting).

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