GMP inspection definition

GMP inspection means an on-site assessment, conducted at a manufacturing facility or other premises, of compliance with GMP, other than a ‘Pre-approval inspection’;
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Examples of GMP inspection in a sentence

  • A Party shall accept the GMP certificates and/or GMP inspection reports issued by the Listed Inspection Service of another Party in accordance with the provisions of this Sectoral MRA referred to in Article 2.

  • Each Party shall ensure that its Listed Inspection Service operates a PIC/S GMP inspection system, as demonstrated by PIC/S membership or adherence to any other equivalent standard as the JSC may determine based on the recommendations of the Panel of Experts.

  • Designating Bodies shall, where necessary, consult with their counterparts in the other Parties, to ensure the maintenance of confidence in the GMP inspection system.

  • The scope of this Sectoral MRA applies to the GMP inspection and certification of manufacturers of medicinal products as defined in Article 1.

  • Each Party shall, upon the request of another Party, provide the requesting Party with a copy of the GMP certificate and/or GMP inspection report in respect of a facility manufacturing medicinal products in its territory, provided that the request is only made in respect of a manufacturing facility whose products are exported to the territory of the requesting Party.

  • Should the National Registration Authority (NRA) begin to carry out inspections itself, inspection reports will also be routinely transmitted to the importing Party until there has been a satisfactory verification of the NRA GMP inspection programme.

  • Two years after the entry into force of the Agreement, the European Community shall, subject to satisfactory verification of Australia’s GMP inspection programme, recognise the conclusions of inspections carried out by the TGA and Australian manufacturers’ certifications of batch conformity.

  • Throughout the Term of this Agreement, CAPSUGEL agrees to cooperate with any governmental or regulatory body, particularly the FDA, which requests a general GMP inspection or audit or any inspection or audit relative to the manufacture, storage, handling, or shipment of Product manufactured, stored, handled, or shipped by CAPSUGEL.

  • In respect of veterinary medicinal products, the European Community will, subject to satisfactory verification of New Zealand’s GMP inspection programme, recognise the conclusions of New Zealand GMP inspections and of New Zealand Manufacturers’ certifications of batch conformity, three years after the entry into force of the Agreement.

  • New Zealand will, subject to satisfactory verification of the European Community’s GMP inspection programme, recognise the conclusions of the European Community’s inspections and of the European Community’s manufacturers’ certifications of batch conformity three years after the entry into force of the Agreement.