TITLE

Establishing Acceptance Limits for Probability of Passing Multiple Stage Tests in Process Validation through a Process Capability Approach

AUTHOR(S)
Cholayudth, Pramote
PUB. DATE
November 2009
SOURCE
Journal of Validation Technology;Autumn2009, Vol. 15 Issue 4, p77
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
The article discusses the use of process capability index (CpK) in pharmaceutical technology, as well as the use of probability of passing multiple stage tests and how to determine their acceptance limit. It is computed to measure the degree of data consistency in process validation. However, its limitation to communication the exact meaning is of its disadvantages. A high chance of conforming to the specification for a quality control (QC) sample may be generated by a product lot of good quality. A CpK limit of not less than 1.33 may be employed in validation in single stage tests.
ACCESSION #
47337028

 

Related Articles

  • Construction of quality control charts by using probability and fuzzy approaches and an application in a textile company. Ertuğrul, İrfan; Aytaç, Esra // Journal of Intelligent Manufacturing;Apr2009, Vol. 20 Issue 2, p139 

    A method that uses statistical techniques to monitor and control product quality is called statistical process control (SPC), where control charts are test tools frequently used for monitoring the manufacturing process. In this study, statistical quality control and the fuzzy set theory are...

  • OPTIMIZATION OF CASP-CUSUM SCHEMES BASED ON TRUNCATED LOG-LOGISTIC DISTRIBUTION. Narayana Murthy, B. R.; Akhtar, P.; Venkata Ramudu, B. // Bulletin of Pure & Applied Sciences-Mathematics;Jul-Dec2012, Vol. 31E Issue 2, p243 

    Among several techniques to control the quality, acceptance sampling plans are introduced mainly to accept or reject the lots of finished products. Such type of techniques are involved in the product which are destructive where 100% inspection is not possible such as bullets, batteries, bulbs...

  • ON FEEDBACK QUALITY CONTROL WITH EWMA. Triantafyllopoulos, K. // Mathematical Scientist;Dec2007, Vol. 32 Issue 2, p110 

    This paper discusses some aspects of exponentially weighted moving average (EWMA) schemes in feedback adjustment for process improvement. A sensitivity analysis shows that the choice of the parameters should be carried out very carefully. An example indicates that different measures of...

  • Two-Parameter Electronic Devices Quality Models.  // Electronics & Electrical Engineering;2010, Issue 103, p3 

    No abstract available.

  • A Dichotomous Search for a Geometric Random Variable. Hassin, Refael // Operations Research;Mar/Apr84, Vol. 32 Issue 2, p423 

    We are given a two-state system that starts in state 0, ends in state 1, and makes a single transition from state 0 to state 1 during N periods. If the system is in state 0, it moves to state 1 in the next period with a known positive time-independent probability. Once it reaches state 1, it...

  • Stability Testing of Pharmaceutical Products - Comparison of Stability Testing Guidelines. Khan, Hamid; Ali, Mushir; Ahuja, Alka; Ali, Javed // Current Pharmaceutical Analysis;May2010, Vol. 6 Issue 2, p142 

    Stability testing is an essential part of pharmaceutical development program and is required by regulatory agencies for establishing and sustaining the high quality products. The ultimate purpose of stability testing is to understand how to design a drug product and its packaging such that the...

  • Statistics in the Service of Quality. Torbeck, Lynn D. // Pharmaceutical Technology;Jun2011, Vol. 35 Issue 6, p34 

    The article discusses the application of statistics as a major tool in assuring product quality in the U.S. It highlights Doctor Walter A. Shewhart of Bell Laboratories who described for the first time a control chart which was then used to study fuses and heat controls. The article also states...

  • Say no to sub-standard drugs.  // Prevention India;Nov2011, p1 

    The article focuses on issues concerning the pharmaceutical industry of India. It discusses poor quality control and availability of sub-standard drugs as a major cause concerning the industry and mentions about the lack of mandatory facilities available in the country for ensuring quality...

  • Risky Business. Singer, Donald C. // Quality Progress;Jul2011, Vol. 44 Issue 7, p44 

    The article focuses on the final-product testing of pharmaceutical companies to ensure quality control of their products. It note that quality tools have helped develop a better understanding on microbiological process control. It stresses that such tools include hazard analysis and critical...

Share

Read the Article

Courtesy of VIRGINIA BEACH PUBLIC LIBRARY AND SYSTEM

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics