SOP FOR SELF-INSPECTION
PURPOSE: To lay down the procedure for Self-Inspection in order to monitor the implementation and compliance with the laid down procedures, cGMP practices and to propose necessary corrective measures.
SCOPE: This procedure is applicable for Self-inspection of manufacturing, packing, holding and distribution areas and related functions associated with manufacturing.
RESPONSIBILITY:
Preparation of SOP: Officer/ Sr. Officer
Checking and Review of the SOP: Executive/Sr. Executive
Approval of SOP: Head of Department/ Assistant Manger
Authorization of SOP: Head QA/Designee
Quality Assurance personnel shall be responsible for preparation of Inspection schedule, Conducting Inspection, Submission of Inspection Report and ensuring of Compliance of deficiencies.
Concerned HOD or designee shall be responsible to follow the procedure and comply the deficiencies.
Executive/Asst. Manager -Quality Assurance is responsible for the implementation/compliance of this procedure.
ACCOUNTABILITY: The accountability of implementation and compliance of the SOP is of Head QA.
PROCEDURE:
Self-inspection: A planned and systematic examination and check of a system, procedure or operation by Self inspector in order to monitor compliance, the effectiveness of established standards, and to allow for improvement and corrective measures where required.
Auditor: An individual or group of persons who are responsible for conducting Self inspection.
Audit tee: A representative from respective area/section of the department being audited.
Inspection Schedule:
Self-inspection team shall carry out periodic Inspection in all the operational departments.
Departments include (as applicable) Warehouse, Production, Quality Control Laboratory, Engineering, Human Resource and Quality Assurance.
Self-inspection schedule shall be prepared for the each operational department, so as to cover each department at least twice in a year.
Additional Self inspection may be carried out in special circumstances but not limited to:
Product recall.
Repeated Product failures.
Serious market complaints.
QA personnel shall prepare the “Self-inspection schedule” and get it approved from the Manager QA in the Format.
QA personnel shall issue the Inspection schedule to the Auditee departments, prior to the Inspection.
Self-Inspection shall be carried out as per schedule.
In case the Self inspection is not performed as per the schedule date, it shall be started within 15 days.
Inspection Team
QA Executive shall constitute the Self inspection team from cross-functional areas comprising of two members, out of which one member shall be from Quality Assurance department.
For a given departmental Inspection, cross-functional team shall exclude the representative from the Auditee department.
Representative from other than Quality Assurance shall audit the Quality Assurance department.
The Head of the department or authorized nominee, of the respective department shall be the Auditee for his/her department.
Inspection
The qualification of the auditors is recorded as per the Format.
The auditors shall verify the compliance with written procedures and completeness of the documents in the respective department/ area and categorize the observations / findings as Critical, Major and Minor in “Self-inspection report” Format.
The auditors shall conduct the inspection as per but not limited to the items specified in the “Self-inspection checklist”.
Actions indicated for the earlier audits along with corrective and preventive action plan shall be verified during the audit.
The categorization of Critical, Major and Minor observation shall be based on the following guidelines.
Critical Observation defined as any observation, which may cause significant effect on the strength, identity, purity and safety of the product and may have an adverse physiological response to the consumer
Major observation shall be defined as any observation, which has produced or may produce a product that does not comply with its marketing authorization, a major deviation from the manufacturing license or GMP approval (overseas manufacturers)
Any observation that has no direct influence on product quality shall be defined as minor observation.
Categorizations of observations are based on the assessed risk level and may vary depending on the nature of the products manufactured. In some circumstances, an example of major deficiency as mentioned above may be categorized as critical.
After completion of audit, the auditor(s) shall conduct exit meeting with concerned HOD or designee (Auditee).
All the Self inspection findings of the respective department shall be reported and submitted in the form of “Self-inspection Report” Format to the Auditee (The Head of the respective department).
Each Self inspection report shall be serially numbered
Auditor shall record the observations in the Format. for the first page and subsequent pages.
Upon receipt of Self inspection report, the Auditee shall prepare agreed action plan in coordination with the QA In charge or designee and shall define timelines for corrective and preventive measures.
The Head of the audited department shall be responsible for the corrective and preventive actions for observations made during the Self inspection.
Auditee shall submit the action plan to QA In charge in the same audit report.
QA In charge or QA -personnel shall follow up with the concerned HOD to correct the deficiencies within the timeline unless otherwise justified.
After completion of necessary corrective actions, QA In charge shall close the audit by preparing “Statement of Self inspection”. In case the corrective and preventive action completion is planned in phased manner then the Self inspection report shall be kept open till the action is completed.
QA In charge and Head of the department audited shall sign the “Statement of Self inspection” with date.
All Self inspection report and compliance response shall be retained with Quality Assurance for one year from the date of closing of audit.
Once every quarter, the observations along with action plan shall be shared with the higher management indicating the status of compliance
Numbering system of Self inspection Report
In case of Self inspection report, QA shall allot a unique number consisting of 9 alphanumerical characters.
The first two alphabetical characters ‘SR’ denote Self inspection Report.
The third character ‘/’ is a forward slash as separator.
Next two numerical characters’25’ indicate the Year 2025.
The sixth character ‘/’ is a forward slash as separator.
The last three numerical characters are serial number starting from 001 every year
REFERENCE:
SOP for SOP
WHO Technical Report series No.908.
Self-Inspection EU GMP Chapter 9.
Annexures:
- Self-inspection Schedule
- Self-inspection Checklist for QC
- Self-inspection Checklist for QA
- Self-inspection Checklist for Engineering
- Self-inspection Checklist for HR
- Self-inspection Checklist for DPI
- Self-inspection Checklist for Tablet
- Self-inspection Checklist for Capsule
- Self-inspection Checklist for Dry syrup
- Self-inspection Checklist for Warehouse
- Self-inspection Compliance Report
- Statement of Self inspection
- List of GMP qualified auditor
- Self-inspection Report
- Auditor Qualification Record