1.0 OBJECTIVE:
1.1 To establish a standardized procedure for planning, coordinating, conducting, and managing inspections performed by Regulatory Authorities, Certification Bodies, Government Agencies, Customers, and other authorized external organizations.

1.2 To ensure inspections are managed in compliance with WHO GMP, cGMP, GDP and Data Integrity principles.

1.3 To define responsibilities for inspection preparation, execution, observation management, CAPA implementation and regulatory commitments.

1.4 To maintain continuous inspection readiness across the site.

2.0 SCOPE:
2.1 This SOP applies to all departments and covers announced, unannounced, routine, pre-approval, WHO PQ, follow-up, for-cause, re-inspections and remote inspections by regulatory authorities and customer auditors.

3.0 RESPONSIBILITIES:
3.1 Quality Assurance (QA):
3.1.1 Overall coordination, inspection readiness, communication, response and CAPA follow-up.
3.1.2 Coordinate regulatory communications and commitments.
3.1.3 Maintain document request log and issue-controlled copies.
3.1.4 Record inspection discussions and observations.

3.2 Department Heads:
3.2.1 Ensure departments remain inspection ready.
3.2.2 Nominate Subject Matter Experts (SMEs) as per the operations.
3.2.3 Ensure personnel availability and documents are updated.
3.2.4 Implement CAPA.

3.3 Head Quality Assurance (QA):
3.3.1 Overall inspection coordinator.
3.3.2 Nominate inspection team.
3.3.3 Verify inspector credentials.
3.3.4 Coordinate all communications.
3.3.5 Ensure availability of documents.
3.3.6 Conduct daily review meetings.
3.3.7 Approve responses.
3.3.8 Monitor CAPA implementation.
3.3.9 Maintain permanent inspection records.

3.4 Managing Director:
3.4.1 Provide organizational support during inspection.
3.4.2 Participate in Opening and Closing Meetings.
3.4.3 Review critical observations.
3.4.4 Ensure adequate resources for CAPA implementation.

3.5 All Employees:
3.5.1 Cooperate professionally.
3.5.2 Answer only questions within their responsibility.
3.5.3 Never speculate.
3.5.4 Follow GDP.
3.5.5 Inform Head QA if uncertain.

4.0 DEFINATIONS:
4.1 Inspection: An official examination conducted by Regulatory Authorities or authorized organizations to determine compliance with applicable GMP requirements.

4.2 Inspection Readiness: The state in which the facility, personnel, systems and documentation remain compliant and available for inspection at any time.

4.3 Observation: A nonconformity or deficiency identified during inspection.

4.4 CAPA: Corrective and Preventive Action implemented to eliminate the cause of non-conformity and prevent recurrence.

4.5 Inspection Coordinator: The individual nominated by Head QA to coordinate all inspection activities.

4.6 Escort: An authorized employee responsible for accompanying inspectors throughout the inspection.

4.7 Scribe: A trained individual responsible for recording inspection discussions, questions and observations.

4.8 Runner: Person responsible for collection and delivery of requested documents.

5.0 PROCEDURE:
5.1 Inspection Readiness:
5.1.1 The site shall maintain continuous inspection readiness at all times.

5.1.2 Inspection readiness shall include:
5.1.2.1 Current SOPs
5.1.2.2 Approved specifications
5.1.2.3 Validated processes
5.1.2.4 Qualified equipment
5.1.2.5 Calibration status
5.1.2.6 Preventive maintenance
5.1.2.7 Training records
5.1.2.8 Data Integrity compliance
5.1.2.9 Housekeeping
5.1.2.10 Pest control
5.1.2.11 Status labelling
5.1.2.12 Material traceability
5.1.2.13 Batch documentation
5.1.2.14 Electronic records
5.1.2.15 Audit trail review
5.1.2.16 Retention samples
5.1.2.17 Complaint records
5.1.2.18 Recall records

5.1.3 Department Heads shall perform periodic readiness assessments.

5.2 Notification of Inspection:
5.2.1 Upon receipt of inspection notification, Head QA shall immediately inform to Managing Director, Site Leadership and Department Heads.

5.2.2 QA shall issue Regulatory Inspection Intimation.

5.2.3 Inspection details shall include Authority, Purpose, Scope, Dates, Inspectors, Language and Special requirements

5.3 Unannounced Inspection:
5.3.1 Unannounced inspectors shall be received courteously.

5.3.2 Reception shall immediately notify Head QA.

5.3.3 Inspectors shall not be permitted to tour the facility until Credentials verified, Appropriate PPE issued and Escort assigned
5.4 Formation of Inspection Team:
5.4.1 Head QA shall appoint Inspection Coordinator, Escort, Scribe, Runner, Document Coordinator and SMEs

5.4.2 Contact numbers shall remain available throughout inspection.

5.5 Inspection Room:
5.5.1 QA shall prepare an inspection room containing Computer, Internet (if approved) and Controlled document cabinet

5.5.2 Only authorized personnel shall enter.

5.6 Opening Meeting:
5.6.1 Opening meeting shall include Introduction, Scope, Duration, Inspection agenda, Confidentiality, Site safety, Photography policy, Sampling policy and Communication protocol

5.6.2 Minutes shall be recorded.

5.7 Facility Tour:
5.7.1 Escort shall accompany inspectors continuously.

5.7.2 Inspectors shall comply with Gowning, Hygiene, Safety and Restricted area requirements

5.7.3 Photography shall only be permitted where authorized.

5.8 Document Control:
5.8.1 Only controlled copies shall be issued.

5.8.2 Each copy shall bear: “REFERENCE COPY – FOR INSPECTION ONLY”

5.8.3 Original documents shall never leave controlled custody unless legally required.

5.8.4 All document requests shall be recorded in the Document Request Log.

5.8.5 Copies of issued documents shall be retained by QA.

5.9 Interviews:
5.9.1 Only trained personnel shall answer questions.

5.9.2 Employees shall:
5.9.2.1 Speak truthfully.
5.9.2.2 Answer only what is asked.
5.9.2.3 Request clarification if required.
5.9.2.4 Refer technical questions to SMEs where appropriate.
5.9.2.5 Speculation shall not be permitted.

5.10 Sampling:
5.10.1 Where inspectors collect samples Product name, Batch number, Quantity, Sampling location, Seal number, Inspector name and Date shall be recorded in the respected BMR/BPR/Log/Register

5.10.2 Where possible, a duplicate sample shall be retained.

5.11 Daily Review Meeting:
5.11.1 At the end of each inspection day QA shall conduct a review meeting.

5.11.2 Agenda shall include Observations, Documents issued, pending requests, Immediate corrections, Preparation for next day minutes shall be maintained.

5.12 Immediate Corrections:
5.12.1 Where possible deficiencies shall be corrected immediately.

5.12.2 Immediate correction shall not replace CAPA.

5.12.3 Evidence of correction shall be documented.

5.13 Closing Meeting:
5.13.1 Head QA shall ensure all relevant department heads attend.

5.13.2 Each observation shall be clearly understood.

5.13.3 Clarifications shall be requested where necessary.

5.14 Regulatory Observations:
5.14.1 Following inspection QA shall:
5.14.1.1 Register all observations.
5.14.1.2 Perform risk assessment / Impact Assessment
5.14.1.3 Assign CAPA.
5.14.1.4 Determine root cause.
5.14.1.5 Establish implementation timeline.
5.14.1.6 Monitor completion.

5.15 Regulatory Response:
5.15.1 Responses shall include Observation, Root Cause, Corrective Action, Preventive Action, Completion Date and Supporting Evidence.

5.15.2 Responses shall be approved by Head QA before submission.

5.16 CAPA Management:
5.16.1 CAPA shall be managed in accordance with CAPA SOP.

5.16.2 CAPA effectiveness shall be verified before closure.

5.17 Regulatory Commitments:
5.17.1 QA shall maintain a Regulatory Commitment Tracker.

5.17.2 The tracker shall include Commitment, Responsible Department, Due Date, Current Status, Completion Date and Verification

5.18 Inspection Closure:
5.18.1 Inspection shall be considered closed only after Responses submitted, CAPA completed, Effectiveness verified, Regulatory commitments fulfilled and Documentation archived.

6.0 REFERENCE:
6.1 WHO Technical Report Series (TRS) – Current GMP Guidelines.

7.0 RECORDS:
Sr No. Title Nature of Document Document No.
NA NA NA NA

8.0 REVISION HISTORY:
Amendment Date: Update Summary Version No.
NA New SOP 01