New edition March 1, 2016 with references to ISO 9001:2015 and ISO 13485:2016.
This document is meant to serve as a support for the ones making quality audits in the pharmaceutical and medical device industries.
The quality systems referenced in this tool are:
• ISO 9001:2008 - Quality management systems
• ISO 13485:2012 - Medical devices - Quality management systems
• 21 CFR 820 - Quality System Regulation for Finished Devices (USA)
• 21 CFR 210 and 211 - CGMP for Finished Pharmaceuticals (USA)
• EU GMP Guidelines, Part I - Basic Requirements for Medicinal Products
• EU GMP Guidelines, Part II - Basic Requirements for Active Substances used as Starting Materials
• EU GDP Guide, 2013/C 343/01 - Good Distribution Practice of medicinal products for human use
An important characteristic of a good audit report is the inclusion of correct references to the audit criteria that where used. This tool facilitates the preparation of an audit checklist and also the report writing and has taken into account the similarities between requirements in all the relevant quality systems.
Preparations - You can create a rational checklist by picking out the relevant requirements from the matrix.
Report writing - You can easily correlate any findings to the requirements of the applicable standard / regulatory text.
Systematics - requirements that occur at several places in the text are highlighted and the requirements are listed on the basis of a modern quality systems perspective.
The tool includes three parts:
Part 1 includes a requirement matrix that can be used in the preparation of checklists prior to the audit. It can also be used to identify cross-references between different quality systems, e.g. GMP and ISO standards.
On each spread, you will find a column with a header “Description of requirement” as well as references to the various standards / regulatory texts. The columns to the left of the description are related to requirements for medical devices and the columns to the right are related to pharmaceuticals. ISO 9001 that may be relevant for both medical devices and pharmaceuticals (i.e for certain subcontractors) is located to the far left.
Part 2 and 3 contain two inspection references from the FDA, one for medical devices and one for pharmaceuticals .
Pages: 116, wire bind
Dimension: A4 (210x297mm)
Publisher: Key2Compliance AB