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

•      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.