Gdp quality manual and procedures

Volume 2 - QUALITY PROCEDURE MANUAL (General procedures and responsibilities) REVISION A . Currie & Warner Limited The Specialists in Precision Turned Parts Registered Office: Summer Hill Works, Powell Street, Birmingham, B1 3DH Telephone: +44 (0) 121 236 8986 - Fax: +44 (0) 121 236 7201 g) Performance indicators, as described in Section ICH Q10, should be identified and used to monitor the effectiveness of processes within the pharmaceutical quality system. Quality manual A Quality Manual or equivalent documentation approach should be established and should contain the description of the pharmaceutical quality system. Chapter 1 Quality Management. 1.1. Quality Assurance is a wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organized arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use. 3. Efficient Temperature Monitoring, Control, and Mapping. Identify temperature risks within the proposed environment, therefore allowing the mitigation of all risks and close monitoring of higher-risk areas and low-risk areas. 4. Approved GDP Providers. Ensure your service level agreements are in line with current EU GDP standards, as well as A control system for Good Distribution Practice (GDP) procedures should address the issue and distribution of procedures and retrieval of obsolete procedures. In this way, only the correct and most recent version of a procedure is in use. 5.2 Appendices - Documentation Control Appendix 02/01 - SOP index The example quality manual For example, assume that procedure QP 7600 with the revision date of November 10, 2005 is being replaced with a new version revised today. The old version would be renamed from "QP 7600.pdf" to "QP 7600 20051110.pdf" and the new one saved as "QP 7600.pdf". No links have to be changed, and the date Quality Manual Template iso-9001-checklist.co.uk Page 5 of 37 1 Introduction Your organization has developed and implemented a quality management system (QMS), which uses ISO 9001:2015 as a framework that allows our organization to document and improve our practices in order to 3 PIC/S PE 011 Guide to Good Distribution Practice for Medicinal Products, specifically operational compliance with procedures. 4.3 Whilst this document has been written with the above scope, many principles 5.2.1 Data governance systems should be integral to the Pharmaceutical Quality System described in PIC/S GMP/GDP. It should Quality Manual Third edition Revision 05 02 April 15 Page 3 of 43 8 MEASUREMENT, ANALYSIS and IMPROVEMENT page 33 8.1 Foreword 8.2 Monitoring and measurement 8.3 Non-compliance management 8.4 Data analysis for improvement 8.5 Continuous improvement 9 ATTACHMENTS page 37 9.1 Procedure Titles Writing Standard Operating Procedure. Standard Operating Procedures (SOPs) are issued to specifically instruct employees in areas of responsibility, Work Instructions, appropriate specifications and required records. SOPs outline procedures, which must be followed to claim compliance with GMP principles or other Statutory rules and regulations. The Agency's work involves harmonisation of GDP activities at an EU level, including: coordinating the preparation of new and revised guidance on GDP; developing EU-wide procedures relating to GDP inspections. Legal framework and guidance . Directives 2