By Syed Imtiaz Haider
A entire when-and-how-to-do-it consultant, this ebook and CD-ROM mixture offers administrative options for attaining compliance with key FDA directions on solid production perform (GMP), sturdy laboratory perform (GLP), and validation. The textual content exhibits readers the best way to identify try capabilities and recognition standards in compliance with FDA views. The CD-ROM comprises seventy four template validation ordinary working methods that clients can edit and print, customizing this system to their wishes. The booklet and CD interact to lessen the variety of types used and to make sure that the all of the right types are used, therefore fending off the tension that typically 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 info for Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical
Val. 30 Effective date: mm/dd/yyyy Approved by: SUBJECT: Design Qualification Guideline for Minimizing the Risk of Product Cross-Contamination by Air Handling System PURPOSE To provide the guideline to be followed for minimizing the risk of product crosscontamination with respect to the air handling system RESPONSIBILITY It is the responsibility of all key supervisors, validation officers, engineers, and managers to build guidelines into the plant architectural structure at the design phase, while placing orders, making purchase requisitions, and in the standard operating procedures to ensure prevention of cross-contamination.
The quality assurance manager is responsible for SOP compliance. PROCEDURE 1. Good Design Practices The design of facilities, equipment, and processes can minimize but not eliminate the risk of cross-contamination. The application of good design practices, if applied and monitored throughout the development of construction documents, will help prevent a high degree of cross-contamination. However, good design cannot overcome poor operating or quality control practices during operation of any facility.
1 Operational qualification (OQ) protocol The OQ protocol should: Ⅲ Include a complete description of the purpose, methodology, and acceptance criteria for the operational tests to be performed Ⅲ Ensure that instrumentation is in current calibration Ⅲ Ensure that detailed control parameters have been established and recorded for each instrument loop Ⅲ Ensure change control systems are in operation Ⅲ Ensure that standard operating and maintenance procedures have been developed (drafted) for each system, to ensure continued operation under defined conditions Ⅲ Ensure that training modules and training sessions for production, engineering, and support personnel have been developed, conducted, and documented during this stage Where appropriate and documented in the validation master plan, the IQ and OQ protocols may form a single document which clearly defines the acceptance for each test(s).