Abstract: . . .  in a written procedure. This should include a description of the arrangements to ensure that they are properly trained and authorised and for ensuring that they are independent of any organisations which they might inspect. 17. PUBLICATIONS 17.1 The quality manual should refer to any lists of licence holders and any other reference documents which are published by the Pharmaceutical Inspectorate.  . . .
. . .  improvement is identified and how improvements are formulated and progressed. Quality planning should be an integral part of a quality improvement programme. 15. ISSUE AND WITHDRAWAL OF LICENCES 15.1 There should be a written procedure to describe the system for the issue and withdrawal of licences. It should include a description of the circumstances under which action can be taken against a licence and the type of action which might be taken and the processes involved. (See also 10.10 above). Records . . .
. . .  operations which may be sub-contracted - criteria for selection of sub-contractors - assessment of competence of sub-contractors - contractual agreements 11. INTERNAL AUDIT 11.1 There should be a system of internal audits to assess compliance with the requirements of the quality system . The audit system should be overseen by the person(s) responsible for maintaining the quality system . The relevant quality system procedure should include : • the systems and procedures to be audited • the frequency . . .
. . .  proposed. 16. SUB-CONTRACTING 16.1 The use of sub-contractors and any limitations imposed on them should be described in a written procedure. This should include a description of the arrangements to ensure that they are properly trained and authorised and for ensuring that they are independent of any organisations which they might inspect. 17. PUBLICATIONS 17.1 The quality manual should refer to any lists of licence holders and any other reference documents which are published by the Pharmaceutical Inspectorate. . . .
. . .  and authorised and for ensuring that they are independent of any organisations which they might inspect. 17. PUBLICATIONS 17.1 The quality manual should refer to any lists of licence holders and any other reference documents which are published by the Pharmaceutical Inspectorate.  . . .
. . .  manual and lists the quality system procedures which should support the manual. Examples of suitable texts are given in italic script for some sections where there will be a degree of commonality between the quality manuals of individual Pharmaceutical Inspectorates. However, it is for each organisation to formulate its own manual based on the guidance which this Appendix provides. Page 14 Page 15 PI 002-1 Appendix ii 19 December 2000 TABLE OF CONTENTS Page 1. Introduction ............................................................................................... . . .
--3000,6,250,3209,36206