Internal Audit, Purpose :
Internal Audit, The purpose of this document is to define a systemic, standardized and effective approach of Self Inspection which is performed by personnel within their own functional or departmental unit. This SOP defines the requirements to ensure that self inspection processes are ‘In Place’ and ‘In Use’ which will
help to:
[][]Promote awareness of quality and GMP to avoid quality problems.
[][]Identify risk and manage it as per Risk Management process.
[][]Encourage ownership of continuous improvement actions.
Internal Audit, Scope :
This SOP applies to the all departments which are included in Audit universe (activity of which may affect quality of products of XX Pharmaceuticals Limited). Audit universe is a list of all departments/sections at the site that are to be audited by a Quality function in a calendar year.
Definitions / Abbreviation:
N/A
Responsibilities:
[][]The roles and responsibility is as follows:
Departmental Head/ Manager
[][]Nominate the self inspection team
[][]Prepare the CAPA against Audit findings and agree the CAPA with Quality Compliance.
[][]Ensure the implementation of CAPA
[][]Ensure the completion of JDI activities
Manager, Quality Assurance
[][]In conjunction with Head of Quality Assurance ensure that audit process is ‘in place’ and ‘in use’
[][]Create and maintain department profile
[][]Posting of CAPA in CAPA tracking system and verify follow up & close-out of CAPA
[][]Prepare the self inspection schedule which identifies areas to be inspected.
[][]Review the audit process and present the status in Quality Review Meeting.
Self Inspection Team
[][]Conduct audit against the standard and identify risk
[][]Assess disclosed risk
[][]Prepare audit report and issue it to Head of Quality Assurance
Head of Quality Assurance
[][]Ensure that audit process is ‘in place’ and ‘in use’
[][]Approve the self inspection schedule
[][]Approve the CAPA
[][]Approve changes to an agreed CAPA or date extension request
Procedure:
[][]Self Inspection Frequency:
[][]Frequency of self inspection in every function/department will be twice a year.
[][]It will be recorded in Quality Assurance Department.
[][]Change of frequency of a section/department must be approved by Head of Quality Assurance.
Create and Maintain the Audit Schedule:
[][]Every department/section will conduct checklist based self inspection in twice a year.
[][]Manager, Quality Assurance will prepare a schedule of self inspection and submit it to Head of Quality Assurance for approval by November of each year for implementation in the next year.
[][]The schedule (Annexure I) will contain the following minimum (but not limited to):
=>Name of the area
=>Type of the inspection
=>Systems (QMS) to be audited
=>Month of the audit
=>Name of the Self Inspection team
=>Proposed period (usually 2nd Week of the month)
[][]The approved schedule for the following year will be communicated by Manager, Quality Assurance to all concerned departments by December.
[][]Manager, Quality Assurance will maintain the audit schedule. Every scheduled inspection can be moved within the +/- 10 days time window, however, any change beyond that would require a formal approval of Head of Quality Assurance.
[][]The schedule adherence will be monitored in every Quality Review Meeting.
Preparation for the self inspection
[][]Head of Quality Assurance will assign a self inspection team. A self inspection coordinator will lead the team.
[][]Self Inspection Coordinator must be trained on audit process. The team members must have at least training on the basic cGMP and auditing process.
[][]Self Inspection team will first identify the Department/Sectional SOPs related to specified systems. In addition, the team will review the minimum following (not limited to):
=>Related SOP
=>Department Practices
=>Procedures
=>Worksheets
=>Checklist
=>Departmental CAPAs from CAPA tracking system
Conduct the self inspection
[][]Self Inspection Team will spend sufficient time of a day for the inspection.
[][]The main focus of the team will be to verify whether the site or sectional SOPs are being followed accurately. Self Inspection team will have to ensure ‘In Place’ and ‘In Use’ of the following:
=>Sectional SOP
=>Relevant SOP
=>Procedures (BMR/BPR/Analytical method etc.)
=>Worksheet (Record of Temperature, log books, analytical sheets etc.)
=>Checklist (Line Clearance, machine cleaning, house keeping)
=>Material & Product standards (Specification, storage etc.)
[][]The self inspection team should take a sample of the documents or procedures for those processes or systems running at the time of the self inspection and review it. The review procedure may be as follows:
=>Ask the operator to describe the task/process
=>Check the description against the procedure (SOP/BMR/BPR/Check sheet)
=>Follow/observe the operation/process
=>Verify the records against specified standards
Record and Report findings
[][]The Self Inspection Team must record the non Assurance from the departmental practices and documentation in the specified template (Annexure II).
Based on the associated risks finding will be classified as either
=>Critical
=>Major
=>Minor
=>Note
[][]Team will follow the Annexure III for categorizing the findings.
[][]Self Inspection Team immediately notify critical finding to Department Manager. Operation associated with the critical finding must be stopped immediately until the issue has been resolved.
[][]Self Inspection Coordinator will prepare a full report (Annexure II) detailing all the self-inspection findings within seven (7) working days of the self-inspection and submit it to Head of Quality Assurance.
Propose, Review and Agree the Corrective and Preventive Actions
[][]Head of Quality Assurance will review the self inspection report and send it to Department Manager.
[][]Department Manager will review the inspection report and immediately address the findings which can be corrected by ‘Just Do it (JDI)’. Few example of the JDI is as follow:
=>Immediate correction of line/material labeling errors
=>Operational errors that can be immediately discussed face to face
=>General good housekeeping requirements, such as, emptying of bags, disposal of waste box, and clearing and tidying of the area.
[][]The JDI action implementation date is to be documented in the report (Annexure II).
[][]Department Manager will prepare an action plan (CAPA) for the findings which require more than 30 days implementing.
[][]Department Manager will forward the report to Manager, Quality Assurance along with CAPA within 4 working days of completing Inspection.
[][]Manager, Quality Assurance will verify that proposed CAPAs would adequately manage the root causes of the identified risk and get it approved by Head of Quality Assurance.
[][]After the approval of CAPAs, Manager, Quality Assurance will formally notify the Department Manager and post all the CAPAs in CAPA tracking system within 2 days where every CAPA has a unique reference number mentioned in the inspection report.
[][]Progress CAPA action to closure
[][]Department Manager will close the CAPA as per target date and inform Manager, Quality Assurance formally with physical evidence (SOP, Validation Report or other as appropriate).
[][]After verifying the evidences Manager, Quality Assurance will close the CAPA in the CAPA tracking system.
[][]For any date extension, approval is to be taken from Head of Quality Assurance before the due date.
[][]In every Quality Review Meeting, CAPA status will be reviewed
Annexure:
Annexure-I: Self Inspection Schedule
Annexure-II: Self Inspection Report
Annexure-III: Classification of findings
Checklist for Internal Audit/Self-Inspection
1.Self Inspection Checklist for Quality Control
2.Self-Inspection Checklist for Production _ Packaging Operation
3.Self Inspection Checklist for Quality Compliance
4.Self-Inspection Checklist for Warehouse