By Syed Imtiaz Haider
A accomplished when-and-how-to-do-it consultant, this booklet and CD-ROM blend presents administrative strategies for reaching compliance with key FDA guidance on sturdy production perform (GMP), strong laboratory perform (GLP), and validation. The textual content indicates readers easy methods to determine try capabilities and popularity standards in compliance with FDA views. The CD-ROM includes seventy four template validation typical working approaches that clients can edit and print, customizing this system to their wishes. The e-book and CD interact to lessen the variety of kinds used and to make sure that the the entire right types are used, hence averting the tension that sometimes accompanies an FDA audit.
Read or Download Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical PDF
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Extra resources for Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical
Sample text
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.
The number of terminal filters must be calculated to guarantee the same air velocity out of the different filter of the same air handling unit. For each filter, a manometer should be connected upstream and downstream of the filter housing and pressure drop measured. When the pressure drop across the filter exceeds the recommended change point, the filter must be replaced. Filter efficiency is defined by ASHRAE 52/76 or EUROVENT 4/5. 5 Fans Air handling unit fans should contain a provision for modulating airflow to compensate for increased static pressure losses as the loading of filters increases.
Val. 20 Effective date: mm/dd/yyyy Approved by: © 2002 by CRC Press LLC 6. Guideline — Validation Review A validation review procedure must be formally defined. Any validation review must be documented in detail and the results of any test should be compared to the original validation results. If the results are satisfactory, the facility or operation may continue to be used. If the results are not satisfactory, operations must be suspended. The facility or operation must be validated before further use.