Self Inspection or Internal Audit and its requirement in Pharmaceuticals

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)

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)
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 .

Self Inspection as per different regulatory Guidelines :

1.WHO describes about the Good practices in self-inspection in Annexure-3 of sec 8.1 to 8.9

2. Schedule M part I describes about the self-inspection and quality audit in section 15.1 to 15.3 of Good Manufacturing Practices

3. USFDA describes about the Self Inspection in PART 211—e-CFR current data as of January 12, 2016 Title 21 → Chapter I → Sub chapter C → Part 211 → Subpart B → Self Inspection

4. MHRA describes about the Self-Inspection in Section II – 2EU Guidance on Good Manufacturing Practice (GMP) – Self-Inspection.

5. TGA describes about the Self Inspection in Chapter 9 -Quality Management.

Conclusion :

1.Self Inspection  is a  tool for internal improvement with respect to cGMP and Regulatory Requirement.

2. Self inspections should be planned with technical persons, having knowledge with respect to the regulatory requirements in that particular field.

3. The inspection shall be conducted for all the departments in the manufacturing facility as per regulatory requirements at least once in year, based on the organization requirements it can be carried out once in quarterly or Half yearly to make sure that all the systems and procedures are under control.

4. The role of Senior Management of the Firm/Organization is important to compile the observation resulted in the self inspection.


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