Common use of Nature of inspections Clause in Contracts

Nature of inspections. a) Inspections will routinely assess the compliance of the manufacturer with GMP. These are called general GMP inspections (also regular, periodic, or routine inspections). b) Product- or process-oriented" inspections (which may be "pre-marketing" inspections as relevant) focus on the manufacture of one or one series of product(s) or process(es) and include an assessment of the validation of and compliance with specific process or control aspects as described in the marketing authorisation. Where necessary, relevant product information (the quality dossier of an application/authorisation dossier) will be provided in confidence to the inspectorate.

Nature of inspections. (a) Inspections will shall routinely assess the compliance of the manufacturer with GMP. These are called general GMP inspections (also regular, periodic, or routine inspections). (b) ‘Product- or process-oriented" ’ inspections (which may be "‘pre-marketing" ’ inspections as relevant) focus on the manufacture of one or one series of product(s) or process(es) and include an assessment of the validation of and compliance with specific process or control aspects as described in the marketing authorisation. Where necessary, relevant product information (the quality dossier of an application/authorisation dossier) will shall be provided in confidence to the inspectorate.

Nature of inspections. (a) Inspections will shall routinely assess the compliance of the manufacturer with GMP. These are called general GMP inspections (also regular, periodic, or routine inspections). (b) Product- or process-oriented" inspections (which may be "pre-marketing" inspections as relevant) focus on the manufacture of one or one a series of product(s) or process(es) and include an assessment of the validation of and compliance with specific process or control aspects as described in the marketing authorisation. Where necessary, relevant product information (the quality dossier of an application/authorisation dossier) will shall be provided in confidence to the inspectorate.

Nature of inspections. (a) Inspections will routinely assess the compliance of the manufacturer with GMP. These are called general GMP inspections (also regular, periodic, or routine inspections).; (b) ‘Product- or process-oriented" ’ inspections (which may be "‘pre-marketing" ’ inspections as relevant) focus on the manufacture of one or one series of product(s) or process(es) and include an assessment of the validation of and compliance with specific process or control aspects as described in the marketing authorisation. Where necessary, relevant product information (the quality dossier of an application/authorisation dossier) will be provided in confidence to the inspectorate.

Nature of inspections. a) Inspections will routinely assess the compliance of the manufacturer with GMP. These are called general GMP inspections (also regular, periodic, or routine inspections). b) Product- or process-oriented" inspections (which may be "pre-marketing" inspections as relevant) focus on the manufacture of one or one series of product(s) or process(es) and include an assessment of the validation of and compliance with specific process or control aspects as described in the marketing authorisation. Where necessary, relevant product information (the quality dossier of an application/authorisation dossier) will shall be provided in confidence to the inspectorate.

Nature of inspections. (a) Inspections will routinely assess the compliance of the manufacturer with GMP. These are called general GMP inspections (also regular, periodic, or routine inspections). (b) “Product- or process-oriented" ” inspections (which may be "“pre-marketing" ” inspections as relevant) focus on the manufacture of one or one series of product(s) or process(es) and include an assessment of the validation of and compliance with specific process or control aspects as described in the marketing authorisation. Where necessary, relevant product information (the quality dossier of an application/authorisation dossier) will be provided in confidence to the inspectorate.

Nature of inspections. (a) Inspections will shall routinely assess the compliance of the manufacturer with GMP. XX X. These are called general GMP inspections (also regular, periodic, or routine inspections). (b) Product- or process-oriented" inspections (which may be "pre-marketing" inspections as relevant) focus on the manufacture of one or one a series of product(s) or process(es) and include an assessment of the validation of and compliance with specific process or control aspects as described in the marketing authorisation. Where necessary, relevant product information (the quality qualit y dossier of an application/authorisation dossier) will shall be provided in confidence to the inspectorate.

Nature of inspections. (a) Inspections will routinely assess the compliance of the manufacturer with GMP. These are called general GMP inspections (also regular, periodic, or routine inspections). (b) ‘Product- or process-oriented" ’ inspections (which may be "‘pre-marketing" ’ inspections as relevant) focus on the manufacture of one or one series of product(s) or process(es) and include an assessment of the validation of and compliance with specific process or control aspects as described in the marketing authorisation. Where necessary, relevant product information (the quality dossier of an application/authorisation dossier) will be provided in confidence to the inspectorate.