Validation & Compliance: Using Risk Analysis in Process Validation

Process validation is used to confirm that the resulting product from a specified process consistently conforms to product requirements. A risk-based approach to process validation provides a rational framework for developing an appropriate scope for validation activities, focusing on processes that have the greatest potential risk to product quality. This article presents a case study in which a risk-based approach was used to evaluate a typical mammalian cell culture and purification process. This risk assessment used a Failure Modes and Effects Analysis (FMEA) to evaluate the impact of potential failures and the likelihood of their occurrence for each unit operation. Unit operations included in the process validation required a risk priority number greater than or equal to a specified threshold value. Unit operations that fell below the threshold were evaluated for secondary criteria such as regulatory expectations or historical commitments.

Author(s):

Leslie Sidor, Paul Lewus

Journal:

BioPharm International, Feb 1, 2007

Copyright:

© Advanstar Communications. All rights reserved.

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Calibration of Lyophilization Pressure Gauges

Gary Osborn and Steve Hansen
Pharmaceutical Technology JUNE 2002 ISO 9000 and FDA requirements mandate that any measurement be traceable to national standards. Calibration of equipment is necessary to ensure traceability, performance, and reliability.This article explains the proper method for the in situ, o­n-site, or off-site calibration of lyophilizer pressure gauges and offers some important guidelines to ensure the accuracy of a capacitance manometer.For full article Click Here

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Pharmaceutical Technology, May 1, 2004
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Pharmaceutical Cleaning Validation Method References

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