Tuesday, July 12, 2016

For Successful Inspection......... (Part I)

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

     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


     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
     Other Regulatory Authorities (TGA , ANVISA etc.)
     Local Authorities?
     Corporate Audits
     Self Inspections or Internal Audits
     Compliance Improvement Projects
     Market Complaints


     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.


  1. I have a question concerning the part of the article on Documentation. Have you ever had to deal with smth like vdr data room ? Was it comfortable for you to make inspection using vdr? Did you face any issues? Thanks in advance for your reply

  2. Thank you for all those materials! That was useful for me. I hope that it will be helpful for the other readers too.

  3. This is a complete guide for checking objects produce any type of product. This is a very good formation of the article.


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