For Successful Inspection……… (Part I)

July 12, 2016
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Why inspection ?

•      To assess & evaluate the ability of a facility to manufacture quality products which consistently meet specification and regulatory requirements.
•      To confirm and assure the validity of:
            Identification, traceability and integrity of lots
            Manufacturing & packaging procedures
            Analytical methods   
•      Confirm that the procedures, processes and methods described in registered dossiers (BLA, NDA, ANDA…) and/or modifications and updates are consistently applied.
•      Follow-up in response to a specific issue (recall).



Responsibility of Inspector

•      Are responsible for verification of compliance with regulatory requirements relating to the manufacture of medicines
Have considerable power…
•      For significant issues, they can recommend to the regulatory authorities that an importation ban be enforced for the market.

Inspectors expectations

•      Assurance that…
–     They understand and approve of the organisation and activities of the manufacturing operations
–     That there are no significant hazards or risks
–     That there is an appreciation of any issues and  that appropriate corrective action plans are in place
–     That a quality system is in place and it is frequently reviewed and improved where and when necessary

•      Respect, honesty and cooperation…
–     Nothing in our behaviour should cause doubt
–     We must NEVER lie or try to hide information
–     We must instil (by our behaviours & systems) confidence and trust.

Audit Preparation


•     Facility
–     Tidiness and good house-keeping both inside and out
–     Clean, tidy and uncluttered working environment at all times
–     Empty all cupboards and drawers of clutter and things that should not be there
–     Empty waste bins daily.
•      Changing rooms
  –   Washrooms and toilets clean
–     Clean, tidy and well-ordered
    

    Site 
–     Clean
–     Tidy
–     Un-littered
•      Documentation
    
–     Verify that the procedures / engineering drawings / and other critical documentation is up to date
–     Review and re-familiarise ourselves with production and equipment logs
–     Review and assess batch records and associated data
–     Assess and review raw data records
–     Review training plans and records
–     Remove and dispose of all ‘post it’ notes and uncontrolled instructions
–     Check for instances of improper changes to documents and possible use of ‘white-out’
–     Collate good ‘examples’ of batch records, change control documents, OOS investigation, CAPA.
•      Review of commitments

–     Previous Inspections and commitments
–     FDA?
–     EMEA/MHRA?
–     Other Regulatory Authorities (TGA , ANVISA etc.)
–     Local Authorities?
–     Corporate Audits
–     Self Inspections or Internal Audits
–     Compliance Improvement Projects
–     CAPAs.
–     Market Complaints
•      Backroom
–     Preparation and collation of all documentation likely to be required for the inspection
–     Communication with external groups (Site, R&D, RA etc.)
–     Working in combination with the runners and administrators
–     Keep records of questions and answers; keeps the team up-to-date with the availability of documents
–     Prepare and verify responses
–     Keeping management up-to-date
•      Points not to forget
–     Clothing and production gowning should be clean and worn as described by procedure
–     Store away all products and components appropriately – not left in workshops or corridors
–     Verify that all materials are labelled (lot numbers, dates, quantity, signature…)
–     Verify the validation status of equipment and production processes (calibration, qualification…)
–     Assure the cleanliness and appropriateness of tools and toolboxes.
           –     Behaviours of site staff
–     Contractors and visitors
–     SOPs at the point of use.
Audit, Drug regulatory and guidelines
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