Validation Articles

Harry G. Brittain
Pharmaceutical Technology JULY 2002

The FDA defined Process Validation in 1987 by the following: “Process Validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specification and quality attributes.” 1The purpose of this article is to discuss how to validate a process by introducing some basic statistical concepts to use when analyzing historical data from Batch Records and Quality Control Release documents to establish specifications and quality attributes for an existing process. In an ideal world, the qualification of processing equipment, utilities, facilities, and controls would commence at the start up of a new plant or the implementation of a new system.


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This article illustrates a qualification– validation strategy for moist heat sterilization and briefly discusses the sterility concept and common sterilization principles. In Part I, the authors present examples for cycle types, parameter requirements for a standard cycle as defined by pharmacopeias, methods used to design sterilization cycles, and various approaches used to measure the efficiency of the sterilization process.

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WHO-EDM Dec 2001

An all-electronic validation can provide storage costs savings and ensured document legibility.

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A Statistically Valid Time Frame or Number of BatchesHow large of a sample set is needed of previously recorded data to determine ranges that are truly representative of the process, and will the ranges be useful in the Validation effort and not set o­ne up for failure? This is a difficult question to answer, and it is important to note that the batches selected should have no changes between them, thus be produced with the same processing conditions. The draft FDA Guidance for Industry, Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients from March of 1998 suggests that 10-30 consecutive batches be examined to assess process consistency.


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Validation was hinted in the 1960s, almost four decades ago. What has changed over the last 30 o 40 years? Has the overall understanding of the term improved? Have all responsible firms truly embraced validation? Are they doing everything within their power to make validations a success? Unfortunately not. While validation is a very necessary element of any firm that falls under the scrutiny of the governing regulatory agencies – both United States and foreign – it has not received the recognition it deserves.

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Andrew W. Jones, Technical Manager, KMI/PAREXEL LLC
ISPE, September 2001 Determine the Confidence Interval as compared to +/- 3S.D. With the +/- 3 S.D. ranges determined, it can be considered important to evaluate what confidence there is that the next data point will fall within this range. The rationale for determining this level is to justify that the +/- 3 S.D. range provides a confidence that 99% of the data is within that range. Similar to the +/- 3 S.D. range, the confidence interval is a range between which the next measurement would fall. This level is typically 99% or greater. Thus a 99% confidence interval means, "there is 99% insurance that the next value would be in the range."

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WHO- EDM

WHO- EDM 1/2002 Validation Part 4 : Q.C. related validation

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