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
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.
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
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
I spection is really good thing to do and know the results of it.
I spection is really good thing to do and know the results of it.
Thank you for all those materials! That was useful for me. I hope that it will be helpful for the other readers too.
Thank you for all those materials! That was useful for me. I hope that it will be helpful for the other readers too.
This is a complete guide for checking objects produce any type of product. This is a very good formation of the article.
This is a complete guide for checking objects produce any type of product. This is a very good formation of the article.