What is Self Inspection

Self Inspection or Internal Audit is a Quality System to check whether activities followed by all departments are according to the written approved procedures and complying with the cGMP and Regulatory Requirements.
What are the Objective of Self Inspection :
  1. Promote awareness for Quality and CGMP  within plant
  2. Proactive approach to identify and correct the non conformance
  3. Assure the effectiveness and support continuous improvement of compliance to CGMP and Quality management system.
  4. Develop confidence to minimize and possibly to eliminate the scope for major or critical regulatory findings.
  5. To identify the non-compliance or Gap with respect to Manufacturing Practices of production, Quality Control systems, quality assurance procedures, engineering practices, environmental conditions etc.
Procedure of Self Inspection:
  1. Internal audit shall be carried out by an organization of its own system, procedures and facilities
  2. It should be conducted in an independent and details way by competent persons.
  3. Self inspection shall be performed routinely or when an inspection by the health authorities is announced.
How to Perform Self Inspection :
1.Internal Audit Team shall audit the various departments as per Internal Audit (Self-Inspection) Schedule.
2. The team shall carefully review the documents and records as per the Check List .
3. In the Internal Audit (Self-Inspection) following points and their records needs to be checked (but not limited to)
Facilities
Personnel
Material Management : Material handling, Man and Material flow and Record keeping
Production, Packing and In-process Controls
Process Equipment / Instruments
Packaging, Identification Labelling and In-process Controls
Storage and Distribution
Change Control , CAPA (Corrective and Preventive Action)
Deviations
Validation (Process, Cleaning etc)
Rejection and Re-use of Materials (Raw, Packing material & Finished product etc.)
Complaint and Recalls
Calibration, Validation and Preventative Maintenance of Equipment’s / Instruments.
Documentation and Control
Data integrity of the recorded data in routine documentation.
Training / Records
Regulatory Documents
Laboratory Controls : QC Records / Stability Data of Products / Logbooks
Implementation of Corrective and Preventive Actions
Contract Manufacturing Records (Including Laboratories)
4. On completion of Self-Inspection the audit observations shall be discussed with the respective department head. Audit Team shall prepare the Self-Inspection Compliance Report and forward to Quality Assurance department.
5. The observations during the Self-Inspection shall be taken-up on priority by concerned department in consultation with Quality Assurance & also the Concerned department shall take necessary Corrective and Preventive Action (CAPA) if required to avoid re-occurrence 

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