Follow
Objective: To provide guidelines for establishing degree of conformance effectiveness of GMP and Quality system through self-inspection quality audit.
Scope: This procedure is applicable for all the operations connected with manufacturing and packing of finished products at (Company Name).
Responsibility
Audit Team: A team of expert from Quality Assurance, Quality Control, Production. Engineering, Training and Research & Development department shall be responsible to conduct the self-inspection /audit as per approved plan.
Lead Auditor: Manager QA shall be responsible for effective implementation of procedure.
The Auditee/Area Leader: Ensures appropriate members of the department management team being available to accompany the self-inspection team for the duration of the self-inspection. The area leader is also responsible that sufficient resources are made available to support the self-inspection preparation, performance and follow up activities. The auditee/area leader is responsible for the initiation and the implementation of corrective actions related to identified self-inspection findings.
Accountibility: Head of Quality
Preacutions: NA
Procedure
6.1 Each of the following area shall be inspected and audited by a cross-functional team (Audit Team).
6.1.1 Production
6.1.2 Quality Assurance
6.1.3 Quality Control
6.1.4 Warehouse (RM, PM & Finished Goods)
6.1.6 Engineering
6.1.7 Research & Development Laboratory
6.1.8 Training
6.2 The self-inspection /Audit team will consist of qualified personnel from:
– Quality Assurance
– Quality Control
– Production
– Engineering
– Training
– Research & Development
6.3 The Head of department of which the audit /inspection is planned shall be termed as Auditee.
6.4 Responsibilities of auditors and Auditee can not be delegated.
6.5 Each area shall be audited / inspected at least twice in a year as per self-inspection calendar (Annexure – IX). Additional audit/inspection may be carried out before any regulatory audit as a part of site preparation. All activities which may have impact on the quality, safety and efficacy of products manufactured and distributed from the site, will periodically undergo a self inspection e.g. cGMP, cGLP and safety.
6.6 The audit scope may be narrowed down to cover only a particular segment / activity.
6.7 The auditors shall jointly inspect the respective area and give their remarks on the enclosed checklist (Annexure I –VIII). The observations may not be limited to the checklist.
6.8 Then the auditors will conduct a physical audit in the respective area. After completion of audit the lead auditor shall prepare the audit report which will be approved by Head of Quality. The audit report will be issued with audit findings categorized as critical, major, minor and notes. Manager, Compliance/Quality shall send a copy of the same to the auditee, other auditors, Head of Manufacturing and Head of Quality within 15 days of audit date.
6.9 The audit findings observed during self inspection will be discussed in Quality Council meeting.
6.10 Depending on the nature of the findings and the risk associated with any non-compliance the following classifications should be used:
6.10.1 Critical: Deficiencies which have a high probability of causing adverse consequences to the patient or consumer; may result in significant deviations in the safety, identity, strength or purity of the product; or are a combination of major deficiencies which indicates a critical system failure. This type of deficiency requires the auditor to define which operations, or supply to BPL, must stop until CAPAs are implemented.
6.10.2 Major: Deficiencies which could potentially cause adverse consequences to the patient or consumer if left un-addressed, could be considered indicative of poor control, could be considered major deviations by regulatory authorities, or a combination of minor deficiencies which indicate a major systems failure, or a number of repetitive minor deficiencies. Requires CAPAs to be agreed although operations can proceed.
6.10.3 Minor: A deficiency which cannot be classified as critical or major. Requires CAPAs to be agreed although operations can proceed.
6.10.4 Notes: A deficiency which is not related to GMP or regulatory compliance requirements (e.g. EHS), but does warrant attention by the auditee. CAPAs do not need to be agreed with the audit team.
6.11 The auditee shall send his corrective and preventive action plan (SOP No.: 032) with due date for implementation to the Manager QA copying to functional heads within 15 days from the date of receiving the audit report.
6.12 Manager QA shall send the above report to Head of Quality along with his comments.
6.13 This corrective and preventive action plan to be followed up through CAPA tracker (Form No.: FQA/137) as per SOP No.: QA032.
6.14 The Self-inspection CAPA will be thoroughly discussed in the Quality Council Meeting to review the implementation status. Relevant functional heads are to present their implementation plan and current status in the Quality Council Meeting.
6.15 Formal closing off of the Audit /Self-inspection shall be certified by the Head of Quality once all the observations recorded in the self-inspection / audits have been
complied with. All the audit observations should be followed up during the next audit.
6.16 Document Numbering
The unique document numbering (Ref. No.) for Self Inspection Report shall be done as under:
ADT SI _Report_Area Identification Code_MM-YY
Where,
ADT SI is Self Inspection audit
_ is underscore
– is dash
Area Identification Code – see in the table below.
MM is the month in two numeric digits e.g. 01 for January, 02 for February, 12 for December etc.
YY is the year in two numeric digits e.g. 08 for 2008, 09 for 2009, 10 for 2010 etc.
Area Identification Code
Warehouse WH
Production (OSD) Prod-OSD
Production (MDI) Prod-MDI
Quality Assurance QA
Quality Control QC
Engineering ENG
Training TRG
Research & Development RD
An example of self inspection audit report reference number for Production (OSD) is:
ADT SI_Report_Prod-OSD_12-08
