GMP-F12 IS22716-2007 Audit Checklist.doc

Facility: Job Number: Address: Scope of audit: Date of audit: Audit Criteria: Auditor: Note: The number in the checklist is referenced to the clause number of the standard. 3. Personnel Item S CR MA MI N/A Observation/comments 3.1 Persons involved in the implementation of the activities described in these guidelines should have appropriate training to produce, control and store products with a defined quality. 3.2 Organization 3.2.1 Organization chart 3.2.1.1 The organizational structure should be defined such that the organization and functioning of the staff of the company be understood. It should be appropriate for the size of the company and the diversity of its product. 3.2.1.2 Each company should ensure that there are adequate staffing levels in the different scope of activity, according to the diversity of its production. 3.2.1.3 The organization chart should show the independence, from the other units of the plant, of each quality unit, such as quality assurance unit and quality control unit. The quality assurance and quality control responsibilities can be undertaken by a separate quality assurance unit and a quality control unit, or they can be undertaken by a single unit. 3.2.2 Number of people The company should have an adequate number of properly trained personnel with regards to the defined activities in these guidelines. 3.3 Key responsibilities 3.3.1 Management responsibilities 3.3.1.1 The organization should be supported by the top management of the company. 3.3.1.2 The implementation of the Good Manufacturing Practices should be the responsibility of top management and should require the participation and commitment of personnel in all departments and at all levels within the company. 3.3.1.3 Management should define and communicate the areas in which authorized personnel are allowed to access. 3.3.2 Responsibilities of personnel