Allied Health Professions

Download Validation Standard Operating Procedures: A Step by Step by Syed Imtiaz Haider PDF

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By Syed Imtiaz Haider

A entire when-and-how-to-do-it consultant, this publication and CD-ROM blend offers administrative ideas for reaching compliance with key FDA guidance on strong production perform (GMP), sturdy laboratory perform (GLP), and validation. The textual content exhibits readers the right way to identify try services and reputation standards in compliance with FDA views. The CD-ROM comprises seventy four template validation general working systems that clients can edit and print, customizing this system to their wishes. The booklet and CD interact to lessen the variety of varieties used and to make sure that the the entire right kinds are used, therefore heading off the strain that sometimes accompanies an FDA audit.

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Additional resources for Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device and Biotech Industries

Sample text

2 Computer-Related Systems in QA and QC 21. 12 Validation Files © 2002 by CRC Press LLC SOP No. Val. 20 Effective date: mm/dd/yyyy Approved by: 22. Validation Schedule 23. 5 Validation master plan review and update The validation master plan is a dynamic document which will be reviewed, updated, and approved as required during the lifecycle of the project. 2. Guideline — Design Qualification Design qualification is documented evidence that quality is built into the design of facilities and operations.

65, current good manufacturing practices: equipment construction Ⅲ Where possible, incorporate cleaning apparatus into the equipment. This can be accomplished either with spray nozzles, spray wands, or spray ball diffusers. Drains should be carefully placed in the equipment so that rinse waters and solvents are allowed to fully drain. © 2002 by CRC Press LLC SOP No. Val. 40 Effective date: mm/dd/yyyy Approved by: Ⅲ Sanitary fittings and valves should be used for product contact applications. 2 Clean in place (CIP) Clean in place (CIP) is a system which involves circulating or once-through water rinses and chemical or sanitizing solutions which are discharged through plant and equipment while kept in an assembled state.

Room Pressure Differentials Room pressure differentials should be adequate to minimize the dispersal of product by ensuring air movement in a controlled and predetermined direction. 6. Recirculation vs. Once-Through Air Handling Systems The following factors should be considered: Ⅲ Return air to air handling plant shall not be product contaminated. Ⅲ HEPA filters in air handling system give adequate protection against product cross-contamination. Select correct HEPA filter. Ⅲ Is air handling system serving other critical product manufacturing areas?

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