Self Inspection in Pharmaceutical Industry

Why Self Inspection is Important in Pharmaceuticals industry …?

Self inspection is mandatory by Regulatory Authorities like MHRA, EU, and USFDA. It is one of QMS tools to see that Quality of Product is not compromised by any component of manufacturing site.

Self inspection should be conducted to check effectiveness & compliance with Good Manufacturing Practice Principles also to provide necessary Corrective method for the same.

Self Inspection should cover personnel matters, Premises, equipment, Documentation, Production, Quality Control, Distribution, complaints recalls & self inspection all during self inspection. It should be pre- Programmed & Pre –arranged so it will be easy to verify their execution. So what is procedure to perform Self Inspection..?? What is Minimum Requirements to perform Self Inspection…?

  1. Audit Team.

  • QA personnel should prepare list of Auditors from every department with proper technical knowledge of various functions of organization for training & conducting Self Inspection with consultation of QA Head.
  • Auditor team should be cross functional with minimum one personnel of Quality assurance.
  • All the internal auditors shall be inculcating the following features during self-inspection.
  • Internal auditor should be known about the area and systems.
  • Internal auditor should be confine to the scope of audit only.
  • Internal auditor should be trained for the audit.
  • One internal auditor shall be auditing only other department. They should not audit their department.
  • Training shall be given to the auditors in case any new auditors introduced in auditor list or any change in self inspection procedure.
  • Deficiency Shall be categorized is as Follows:-
  • Minor – no significant impact on product quality/safety.
  • Major – significant impact on product quality/safety.
  • Critical – significant impact on product quality/safety surely to have serious & harmful effect on the patient.
  1. Schedule of Audit.

  • QA personnel should prepare Audit plan/Schedule for year of all departments .
  • Quality assurance shall be intimate to respective departments about the scheduled date of audit, persons who will be auditing, audit report submission time, audit report findings to respective departments, time frame for corrective & preventive action for non-compliances and submission of the documents for compliance of observations report
  • QA personnel should lead Audit.
  1. Audit Activity.

  • Audit members shall be arrange the opening meeting with all the concerned and explain the purpose, scope and the methodology of the audit.
  • Audit must be conducted as per specified Check list as per Department Vise.
  • Scope of Audit should be but not limited to SOPs, SMF,VMP,BMR/BPR/MFR/TT/Method Transfer, Change Control, Deviations , Formats, incidents , product recalls, Market complaints, Compliance of internal and external audits, Pest control, Medical, cGMP Handling of materials, Stability, Analysis of RM/PM/FP, Calibration of instrument, Qualification / Validation, Hold time study, Preventive maintenance schedule, Breakdown history of instrument/ equipment.
  • The audit team shall be check & record the audit observations / non-conformances as per checklist and observed non-conformance.
  • Head QA should review audit observations and respective departments should prepare take action on Non Conformance in given time line.
  • CAPA should be provided by concern department.
  • All Observations compliance time line should be given in SOP.
  1. Compliance & Closure of Audit Observations.

  • QA shall close the nonconformance after satisfactory review of documents which is provided by the Auditee department /other different departments or physical verification basis.
  • QA shall be review the effectiveness of the corrective and preventive action in subsequent self inspection.
  • QA shall be closed the audit observation report after completion of all observed non-compliance
  1. Audit by customers/ External Agency/ Regulatory.

  • Non conformance reports of self inspection is only for internal reference and not to be forwarded to any customers / External agency / Regulatory but if any auditors / visitors asked for the reports then only can be shared.
  1. Preservation of Documents.

  • Audit documents should be preserve till mentioned time line.
  1. Frequency.

  • Self inspection shall be perform twice in a year.

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