Table of Contents
1.0 OBJECTIVE
1.1 To lay down the procedure for conducting self inspection in various departments to verify the compliance with cGMP (current good manufacturing practices) and regulatory requirements, quality policy of the organization and laid down standard operating procedures to verify scope for any improvement.
2.0 SCOPE
2.1 This procedure is applicable for the procedure involved in conduction of self inspection, preparation and review of self inspection observation, action plan & compliance report, execution of corrective and preventive actions, for the non-conformances observed during the self inspection.
3.0 RESPONSIBILITY
• Executive or above-QA department shall be responsible to prepare self inspection planner, coordination and maintaining the records of Self Inspection.
• Head of the department (auditee) or his designee shall be responsible to review of self inspection observations, action plan & compliance report for non conformance observed during the self inspection.
4.0 ACCOUNTABILITY
Head Quality / QA
5.0 PROCEDURE
5.1 Self Inspection is an examination and assessment of all processes and procedures with respect to quality system with specific purpose of improving the quality system and evaluation of manufacturer’s compliance to establish quality systems and cGXP requirements.
5.2 Self Inspection shall be conducted twice in a year for each department at an interval of six months. The audit shall be performed to assess the compliance status of the quality system. Self inspection shall be conducted by auditors other than their own departments.
5.3 Situation which can trigger self inspection may be but not limited to:
• Scheduled frequency, product / system failure or complaints
• Product recall
• Series of major/major Non conformance raised by QA
• Out of Specification
• Repeated rejections
• Inspection by any regulatory authorities is announced
5.4 Records of self inspection shall be maintained by QA.
5.5 Self Inspection Team:
5.5.1 A Self Inspection team shall comprise HODs & their designee from all departments i.e. Quality Assurance, Quality Control, Production, Warehouse, Human Resource and Engineering.
5.5.2 Self Inspection team member shall have minimum 05 year of experience with sound knowledge of GMP to perform the self inspection.
5.5.3 The selection of auditors for conducting internal audits shall be assessed on the basis of their qualification, SMEs and experience in related trade and regulatory inspections experiences.
5.5.4 Selection of the internal auditors shall be carried out through training program.
5.5.5 After successful completion of training program, a qualified auditor certificate shall be issued from Head QA /Designee to concern person.
5.5.6 After certification, List of auditors shall be prepared, reviewed by Officer/Executive QA and approved by Head-QA / Designee.
5.5.7 To carry out self Inspection of any department minimum two internal auditors from different department other than the department to be audited shall be selected in consultation with Head QA or his/her designee.
5.5.8 In Self Inspection audit team at least one auditor shall be from QA Department.
5.6 Planning of Self Inspection:
5.6.1 Officer / Executive of QA department shall prepare, review a self inspection plan and circulate to all concerned department heads and approved by Head QA / Designee.
5.6.2 The self inspection planner shall be prepared in the month of December ± 10 days.
5.6.3 Self Inspection shall be carried out in the scheduled month as per the approved calendar.
5.6.4 If in any case the self inspection is not conducted in the scheduled month, it shall be conducted in the first week of next month.
5.6.5 Officer / Executive of QA shall initiate the self inspection and generate a unique number for each self inspection to be conducted and record the same in the self inspection checklist.
5.6.6 Self Inspection numbering system
NN-DD/MM/YY-ZZ
Where, NN : Serial No. of the Internal audit conducted starting from 01, 02…
DD/MM/YY : Date, Month and Year of internal audit.
ZZ : 01 & 02 half inspection
5.6.7 Self Inspection numbering shall be recorded in self inspection log book.
5.6.8 Quality Assurance personnel shall intimate the proposed scheduled date of audit to concerned departments at least 15 days in advance through e mail.
5.6.9 Self inspection shall be carried out within ± 15 days of scheduled date of self inspection.
5.6.10 The Head of Auditee department or his designee shall be Auditee during self inspection.
5.6.11 Audit checklist and self inspection observation report shall be issued to auditor prior conducting self inspection.
5.6.12 The audit shall consist of in depth review of approved systems to confirm conformance with established standards, specification, protocol, procedures, policies, manuals, guidelines, cGMP practices, Safety Health and environment (SHE) aspects and other requirements of regulatory and statutory compliance.
5.6.13 Before the start of audit, auditors shall review the last audit findings & its compliance status.
5.6.14 QA shall prepare, review audit checklist for self inspection of each department as using Template as per Format No. QA01-021/F05 and approved by Head QA/Designee.
5.6.15 Audit checklist shall be revised every three years from the date of effective.
5.6.16 Checklist number shall be assigned are as follows:
SICL/DD-SS
SICL – stands for self inspection checklist
DD -stands for department code
SS -stands for version number
5.6.17 The audit team shall have access to all files, records and raw data to verify conformance.
5.7 Reporting of Findings:
5.7.1 The audit report comprising of agreed, finding based, factual evidences shall be prepared. It is necessary to record:
- What was found?
- Where it was found?
- Why is it a deficiency?
5.7.2 Following observations shall be treated as non conformances, but not limited to:
• No written instructions
• Failure to follow instructions
• Unauthorized document changes
• Obsolete document in use
• In-effective corrective action
• Un-calibrated equipment in use
• Repair operation not done
• No documented evidence of the work
• No calibration records
• Non compliance to Regulatory requirements
5.7.3 The observations shall be categorized by the Auditor who conduct the audit and mention in audit observation report.
5.7.3.1 Major: Observation which has significant impact on product quality and/or safety and likely to have serious and /or harmful effect on the patient.
5.7.3.2 Moderate: Observation other than major, that is likely to result in a failure or reduction in the suitability of use of a unit for its intended purpose.
5.7.3.3 Minor: Observation that is not likely to reduce feasibility of the unit of product for its intended purpose or as departure from established standards having little bearing on the effective use or operation of the unit.
5.7.3.4 Repeated: Observation that are observed more than three times in a calendar year are called repeated observation, in this category even a minor observation is repeated will became a major & prompt action will be taken on it.
5.7.3.5 Categorization of the observation shall be done based on the risk to product quality / facility / system. Scoring shall be done on basis of severity,
| Probability score (p) | Detectability score (d) | ||
| Highly improbable to occur | 2 | Control system in place has a high probability of detecting the defects or its effects | 2 |
| Improbable to occur | 4 | Control system in place, could detect the defects or its effects | 4 |
| Probable to occur | 6 | Control system in place has a low probability of detecting the defects or its effects. | 6 |
| Highly probable to occur. | 8 | There is no control system to detect the defect | 8 |
| Severity score (s) | |||
| Minor GMP non-compliance, no possible impact on patient, yield or on production capability. | 2 | ||
| Significant GMP non-compliance, possible impact on patient, moderate impact yield or on production capability. | 4 | ||
| Major GMP non-compliance, probable impact on patient, high impact on yield or production capability. | 6 | ||
| Serious GMP non-compliance, probable serious harm or death, impact on yield or production capability. | 8 | ||
5.7.3.6 On the basis of severity score, probability score & detectability score, risk rating shall be done. Risk rating shall be done by multiplying severity score; probability score and detectability score (Severity Score x Probability Score x Detectability Score).
On the basis of risk rating, categorization of observation shall be done as MAJOR, MODERATE, MINOR which shall be as follows:
• Major Observation (Risk Level >216)
• Moderate Observation (Risk Level >64)
• Minor Observation (Risk Level ≤ 64)
5.7.4 Auditors shall prepare audit observation report on the basis of findings/non-compliance observed during the audit and submit to QA department within 7 working days from the date of audit completion.
5.7.5 QA Department shall forward the same to HOD of auditee department for recommendation of corrective & preventive action for deficiencies observed.
5.7.6 Auditee Department shall prepare audit compliance report and same shall be verified by QA Coordinator.
5.7.7 Note: Repeated observations shall be treated as significant observations which may become a major & prompt action will be taken on it, if any.
5.7.8 In case of major deficiency (if any) observed immediate prompt action to be taken.
5.8 Corrective Action:
5.8.1 The HOD of Auditee department shall prepare the compliance report with recommended corrective & preventive action/target date and same shall be submitted to QA Department within 15 working days from the receipt of audit report.
5.9 Follow Up Audit and Closing of Observations:
5.9.1 QA shall review the recommended corrective & preventive action (CAPA) with target date for the deficiencies observed for appropriateness of CAPA. In case of inappropriate CAPA (if any) shall be corrected with consultation of Head-QA/Designee.
5.9.2 Audit closure date shall be consider after receiving of audit compliance report.
5.9.3 Target completion date can be extended with proper written justification from concern department Head then on the basis of justification approval can be granted from Head-QA/designee in case the corrective action couldn’t be completed due to justifiable reasons such as delay in availability of resources, time taking modifications, corrective action needs approval of budget and procurement etc.
5.9.4 After implementation of corrective and preventive action audit compliance report shall be prepared by concern auditee department and same shall be verified by QA.
5.10 TCD Closure:
5.10.1 Self inspection executed documents shall be archival by QA with following documents as per below.
• Audit Checklist.
• Audit Observation report
• Audit Compliance report along with implemented supporting documents.
5.10.2 The self inspection report & its related documents shall be maintained in archival of QA for 05 years after completion of self-inspection report.
5.10.3 The audit observation which can be common to other departments shall be shared with them to take appropriate preventive measures, if needed.
5.10.4 Internal audit observation shall not be shared to auditors/customer, if insist to check the observation related to internal audit then decision shall be taken from management representative to share the observation and its CAPA details.
5.11 TCD of Activities:
5.11.1 Audit observation report shall be submitted within 7 working days from the date of audit conducted.
5.11.2 Audit compliance report shall be submitted to QA by auditee department within 15 working days.
5.11.3 Audit compliance report with action implementation details shall be submitted to QA by auditee department after action impletion.
6.0 ABBREVIATIONS
S.O.P – Standard Operating Procedure
Q.A. – Quality Assurance
F – Format
No. – Number
SME – Subject matter expert