Laboratory quality system manual

Download Now Download Download to read offline. Quality Manual Mar. FirasMfarrej Follow. Software quality management plan. Quality principles and concepts. Quality manual for small and medium companies. Quality management slides. Quality management. WP3 Quality Management Plan.

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Bigboss Director Charlotte Putnam Dec. Kipchumba Mugun Feb. By looking at the contents of a Quality Manual then an auditor will start to get an appreciation of an organisation in advance of an audit. Chapter 4 of European Union Good Manufacturing Practice EU GMP covers the documents and records required by a pharmaceutical manufacturing site, yet unfortunately it makes no mention of a Quality Manual or what its contents should be. Well the answer is YES.

This is likely to be due to the fact that when Chapter 4 was last updated June there was no mention of a Quality Manual in Chapter 1 at that time, which was then later updated in January Hopefully any future update of Chapter 4 will include more detail of what should be contained in a Quality Manual.

Clause 1. A Quality Manual or equivalent documentation approach should be established and should contain the description of the pharmaceutical quality system. The description should include:. Process maps and flow charts can be useful tools to facilitate depicting pharmaceutical quality system processes in a visual manner.

Poor Quality Manuals normally involve simply copying the requirement of the standard into the manual itself. This is of little value. A good Quality Manual covers HOW an organisation intends to achieve the requirement of the standard that it is based on, for example:. If designed well it can be used as a tool to sell an organisation, to show what a positive quality ethos they have and can show how good an organisation is and how seriously it takes its Quality Management System.

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In we will also begin to offer some traditional classroom courses - see details on each course page. Click on course name for full course details and dates:. Advanced Good Manufacturing Practice. Data Integrity. Documentation and Records in GMP. Good Distribution Practice. Good Manufacturing Practice. Internal Auditor. GMP Problem Solving. Responsible Person RP.

Sterile Products. Online courses available anytime anywhere Data Integrity. Pharma Quality Management Systems module.