Cover Image
QR Code

Statistical Tools for Development and Control of Pharmaceutical Processes: Statistics in the FDA Process Validation Guidance.

The recent US Food and Drug Administration Process Validation Guidance has provided clear statements on the need for statistical procedures in process validation. FDA has redefined validation to include activities taking place over the lifecycle of product and process-from process design and develop...

Full description

Published in:Journal of Validation Technology (JVT) Vol. 20; no. 1; pp. 1 - 7
Main Author: Pluta, Paul L.
Format: Journal Article
Published: Institute of Validation Technology Mar2014
Online Access:View this record in EBSCOhost
fields @attributes:
  recordID: 1
pdfLink:
plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=95406197&site=ehost-live
header:
  @attributes:
    shortDbName: ccm
    uiTerm: 95406197
    longDbName: CINAHL Complete
    uiTag: AN
  controlInfo:
    bkinfo:
    dissinfo:
    jinfo:
      jid:
        10796630
        38NF
      jtl: Journal of Validation Technology (JVT)
      issn: 10796630
      maglogo: N
    pubinfo:
      dt: Mar2014
      vid: 20
      iid: 1
      pid: 34717
      pub: Institute of Validation Technology
      place: Duluth, Minnesota
    artinfo:
      ui:
        95406197
        95406197
      ppf: 1
      ppct: 6
      formats:
      tig:
        atl: Statistical Tools for Development and Control of Pharmaceutical Processes: Statistics in the FDA Process Validation Guidance.
      aug:
        au: Pluta, Paul L.
      sug:
        subj:
          United States Food and Drug Administration Standards
          Product Development Standards
          Technology, Pharmaceutical Trends
      ab: The recent US Food and Drug Administration Process Validation Guidance has provided clear statements on the need for statistical procedures in process validation. FDA has redefined validation to include activities taking place over the lifecycle of product and process-from process design and development through ongoing commercialization. New applications have evolved as result of this guidance. Statistical applications should be used in process validation and related applications to improve decision-making. Development efforts should include statistically designed experiments to determine relationships and interactions between inputs and outputs. Manufacturers should understand the sources of variation, understand its impact on process and product, and control variation commensurate with the risk. Statistical methods should be used to monitor and quantify variation. Statistical methods should be used in support of sampling and testing in process qualification (PQ). Sampling plans should reflect risk and demonstrate statistical confidence. Validation protocol sampling plans should include sampling points, numbers of samples, sampling frequency, and associated attributes. Acceptance criteria should include statistical methods to analyze data. Continuing process verification data should include data to evaluate process trends, incoming material, in-process materials, and final products. Data should focus on ongoing control of critical quality attributes. FDA recommends that personnel with adequate and appropriate education in statistics should be used for these activities.
      pubtype: Academic Journal
      doctype: Journal Article
      ougenre: Article
    language: English
    refInfo:
    holdings:
      @attributes:
        islocal: N