1.0
Purpose
1.1
To describe the procedure of conducting self –
inspections as a part of the quality assurance system in order to monitor the
implementation of current Good Manufacturing Practice (cGMP) in the site
operations and to propose necessary corrective /preventive measures. It is an
effective tool for ensuring compliance with relevant GMP and regulatory requirement.
Records of such Self inspections and any subsequent corrective and preventive
actions shall be maintained.
2.0
Scope
2.1 Self inspection should be conducted in
order to monitor the implementation and compliance with Good Manufacturing
Practice (GMP) principles and to propose necessary corrective measures of NAME Pharmaceuticals Ltd.
3.0
Responsibility
3.1
Head of Quality Assurance is
responsible to ensure the training of the auditors responsible for
Self-Inspection.
3.2
Officer/Sr. Officer, QA is
responsible to prepare annual Self-inspection Schedule, audit agenda, verify
the action taken and prepare yearly review report.
3.3
Head of Quality Assurance is
responsible to approve the audit schedule, constitution of audit
team and implementation of
each audit schedule, provide guidance where required, approve the action plan , close out the audit
observations and approve the review reports.
3.4
Head of Quality Assurance or
deputy is responsible to follow up of audit observations with corrective
actions and preventive actions (CAPAs) and discuss in the quality
management
review meeting for the
outstanding CAPAs.
3.5
Audit team members are
responsible to carry out the audit and submit the audit report to QA .
3.6
Responsible persons for the
action is to carry out the agreed corrective & preventive action within
agreed time line & to provide documentary evidence to QA after action
taken.
4.0 Abbreviations and Definitions
4.1 Internal Audit: A systematic internal examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented and maintained effectively.
4.2 Critical observation: Any observation that directly affects the safety of products and is likely to result in an immediate or latent health risk to the recipient, or fraud misrepresentation or falsification of product(s) or data.
4.3 Major Observation: Any Observation that potentially affects the safety of the products and could result in an immediate or latent health risk to the recipient. Major observation is a major deviation from the GMP regulations.
4.4 Minor observation: Any observation that neither critical nor major and has low or negligible impact on the safety of the product (s). Minor observation is a slight departure from the GMP regulations.
4.5 GMP: Good Manufacturing Practices
5.0 Materials and Equipment
5.1 None
6.0 Precaution / Health and Safety Considerations
6.1 Wear the appropriate safety equipment & garments for each area to be audited.
6.2 Assign only qualified auditors to conduct self-inspections.
6.3 The personnel employed in an area should not be included in the audit team formed for auditing that area.
7.0
Procedure
7.1
Officer/Sr. Officer, QA will prepare annual
Self-Inspection schedule covering Departments / Sections which will be audited and take approval from Head
of QA.
7.2
Fixed the Department /Section wise audit frequency
as per following table –
Department
/ Section |
Audit Frequency |
Warehouse |
Twice in a year |
Production |
Twice in a year |
Engineering |
Twice in a year |
Quality Control &
Microbiology |
Twice in a year |
Quality Assurance |
Twice in a year |
Product Development |
Twice in a year |
Plant Admin & HR |
Twice in a year |
7.3
Share this approved annual Self-Inspection
schedule to the respective department which will be audited.
7.4
Constitute a self-inspection team of at least
2 members. The team will include personnel not employed
in that area and will conduct the audit in an independent and detailed way by
the qualified auditors. One of the
team members will be from QA and he /
she will act as a lead auditor
responsible to lead the audit team (such as conduct opening meeting , auditing,
wrap up meeting, audits by
external experts can also to be conducted for better compliance.
7.5
Audit team or QA shall prepare “Self-Inspection
/ Internal Audit Agenda” (Annexure-I) and inform
the head of the respective department at least five days before the audit date.
7.6
QA will inform the respective department to be
audited if it is not possible to conduct audit as per the schedule. In that case carry out the audit within 10 working
days from the scheduled date.
7.7
Audit team member circulate from the QA
department.
7.8
Carry out an opening meeting with the audited
at the beginning of the audit.
7.9
Review (audit team member) the previous
inspection report of the respective department, outstanding CAPAs if any and during conducting the audit verify the
follow up actions and implementation
of CAPAs. Also review the current GMP requirements and other relevant guidelines for that particular Department/section.
7.10
Note down the observations made during the
inspections in the audit note book and where applicable.
Proposals for corrective / preventive measures. Ensure that all the check point
in “CHECK LIST- SELF INSPECTION /
INTERNAL AUDIT” (Annexure-IV).
7.11
Perform a wrap up meeting at the end of each
audit day informing all audit observation to
the auditee. In the wrap up meeting
both auditees and auditors will make clarification and agree the observations noted during audit.
7.12 Prepare the “SELF INSPECTION/ INTERNAL AUDIT
REPORT” (as per Annexure-II) assigning an audit reference number for each audit
report abbreviation of Self inspection /specify the area or location /two
numerical digit of serial number / last two numerical digit of the current year.
e. g. SI/PR/01/24
7.13
List the number of the observations and
categories the issues based on criticality of the audit findings (critical /
major / minor) as mentioned in “SELF INSPECTION/ INTERNAL AUDIT REPORT”
7.14
Audit team or QA will share the audit report
with the respective departmental head within 3 working days to provide the
action plans.
7.15
Respective department will provide the action
plans of audit reports in the “AUDIT OBSERVATIONS AND ACTION PLANS”
(Annexure-III.) with signature to QA Department within 7 working days defining the corrective and
preventive actions to be taken with name / designation
of the responsible person and the timeline.
7.16 Head of QA and Plant Manager are respectively
approved and authorized the “AUDIT OBSERVATIONS AND ACTION PLANS” (Annexure-III.) within next 3 working days and share
the report with the respective department to take action as agreed. Also fill
up Annexure-III to handle the CAPAs.
7.17
Enter each CAPA in the excel sheet as in the
“Procedure for handling of CAPA plans and tracking and put CAPA
reference number.
7.18
Monitor (QA) all outstanding CAPAs to ensure
satisfactory and timely completion of audit observation.
if it is required for time extension (once) and /or review action the revised
time line and action should be
agreed by the responsible person for the action and Head of QA.
7.19
Inform (Audited) QA along with supporting
documents when the action has been taken.
7.20 Verify (QA) and close the action when it is
reported as completed and update the status of each action. Attach the evidence with the self-inspection form (Annexure-III.)
7.21
Arrange a quality management review meeting
regarding the status of the completion of CAPAs,
the outstanding CAPAs and follow up effectiveness of the actions taken with the
responsible area managers.
7.22 Prepare a annual and yearly review report of self-inspection
covering the completion status of actions
and outstanding CAPAs. Discuss in the quality management review meeting.
8.0
Reference
Document
8.1 In-house
9.0
Annexure
9.1 Annexure-I : Self
Inspection / Internal Audit Agenda
9.2 Annexure-II : Format of “SELF
INSPECTION/ INTERNAL AUDIT REPORT”
9.3 Annexure-III : Format of “AUDIT OBSERVATIONS AND ACTION PLANS”
9.4 Annexure-IV : “CHECK LIST-SELF INSPECTION / INTERNAL
AUDIT”
10.0 Revision History
Revision No. | Brief reason for the revision | Effective Date | Remarks |
01 | New |
|
|
11.0 Training
11.1 Head of Quality Assurance or his nominee give the training of production operator and worker.