Bars

Major GMP Guidlines

• Compilation of Community Procedures on Inspections and Exchange of Information

• Quality systems framework for Good Manufacturing Practice (GMP) inspectorates

• Management and classification of reports of suspected quality defects in medicin ...

• Management of rapid alerts arising from quality defects risk assessment

• Conduct of inspections of pharmaceutical manufacturers or importers

• Outline of a procedure for co-ordinating the verification of the GMP status of m ...

• Guideline on training and qualifications of good manufacturing practice (GMP) in ...

• Guidance on the occasions when it is appropriate for competent authorities to co ...

• The issue and update of good manufacturing practice (GMP) certificates

• A model for risk based planning for inspections of pharmaceutical manufacturers

• Procedure for dealing with serious good manufacturing practice (GMP) non-complia ...

• Procedure for dealing with serious good manufacturing practice (GMP) non-complia ...

• Guideline on training and qualification of inspectors performing inspections of ...

• Good distribution practice (GDP) inspection procedure

• The issue and update of good distribution practice (GDP) certificates

• Co-ordinating good manufacturing practice (GMP) inspections for centrally author ...

• Procedure for compliance management

• EU/EEA programme for maintenance of equivalence in supervision of good manufactu ...

• Interpretation of the Union format for manufacturer / importer authorisation

• Interpretation of the Union format for good manufacturing practice (GMP) certifi ...

• Interpretation of the Union format for a wholesale distribution authorisation

• Good manufacturing practice (GMP) inspection report – Union format

• Union format for manufacturer’s authorisation

• Union format for a good manufacturing practice (GMP) certificate

• Statement of non-compliance with good manufacturing practice (GMP)

• Notification of serious good manufacturing practice (GMP) non-compliance informa ...

• Union format for a good distribution practice (GDP) certificate

• Union format for a good distribution practice (GDP) certificate for active subst ...

• Good distribution practice (GDP) inspection report – Union format

• Union format for a wholesale distribution authorisation

• Statement of non-compliance with good distribution practice

• Statement of non-compliance with good distribution practice of a distributor of ...

• Request form for the exchange of information on marketing authorisation holders ...

• Union format for registration of manufacturer, importer or distributor of active ...

• History of changes to the compilation of procedures