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Self inspection and Quality Audits

Background:

As per schedule  M of "Drug and Cosmetic Act" self inspection is a tool to evaluate the manufacturer's compliance with GMP in all aspects of production and quality control. It is responsibility of manufacturer to consist a team of independent, experienced, qualified person from within or outside the company. 

The procedure for self inspection shall be documented indicating self inspection results; evaluation, conclusion and recommended corrective action with effective  follow up  program.

As per EU GMP requirement  (Chapter 9 Self Inspection) "Self inspection should be conducted in order to monitor the implementation and compliance with Good Manufacturing Practice principle and to propose necessary corrective measures.

Principle:

The purpose of self-inspection is to evaluate the manufactures compliance with GMP in all aspect of production and QC. Self inspection should be performed routinely an may be, in addition, performed on special occasions, example in the case of product recalls or repeated rejections or when an inspection by the health authorities is announced.


Items for self inspection: 

Writing instructions for shelf inspection shall be drawn up which shall include the following. These may include questionnaires on GMP requirements on GMP requirements.  
  • Personal
  • Premises including personal facilities
  • Maintenance of buildings and equipment's
  • Storage of starting materials and finished goods
  • Equipment
  • Production and in-process controls
  • Quality control
  • Documentation
  • Sanitation and hygiene
  • Validation and revalidation programmes.
  • Calibration of instruments or measurement system
  • Recall procedure
  • Complaints management
  • Label control
  • Results of previous shelf inspection and any corrective step taken.
Self inspection team

Management should appoint a self inspection team made of experts in their respective fields who are familiar with cGMP.

Frequency of Self inspection. 

Self inspection are conducted may depend on company requirement but should preferable be at least once a year.

Self inspection report

Self inspection report should include:
  • Self inspection results
  • Evaluation and conclusion
  • recommended corrective action.

Follow-up action

There should be an effective follow-up programme. The company management should evaluated both the self inspection report and the corrective action as necessary.


Ref:
Annex 2 WHO good manufacturing practice for pharmaceutical products: main principle
Schedule M of Drug and Cosmetic ACT 1940 (India)
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Location: India

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