Implementing Process Validation Guidances

Calcott, Peter H.
March 2013
Contract Pharma;Mar2013, Vol. 15 Issue 2, p54
Trade Publication
The article discusses how to implement the Process Validation Guidances which was released by the Food and Drug Administration for the pharmaceutical industry in the U.S. It mentions that the rationale and reasoning for process validation is described in the guidance. It describes three components which should be considered in implementing the guidance.


Related Articles

  • Prefillable Syringe Systems. Hlobik, Tibor // Pharmaceutical Processing;Jan2011, Vol. 26 Issue 1, p14 

    The article focuses on the integration of prefillable syringe system in the U.S. market, which gives rise to pressures faced by drug manufacturers concerning their packaging decisions, such as by the U.S. Food and Drug Administration (FDA). It says that prefillable syringe market begun a trend...

  • Validation Issues for OTC Drug Manufacturers. Nusch, Karl David // Global Cosmetic Industry;Mar2000, Vol. 166 Issue 3, p34 

    Discusses some validation elements and concepts developed by the United States Food and Drug Administration to ensure over-the-counter drug manufacturers' compliance with the Food Manufacturing Practices. Process validation; Water system validation; Analytical methods used for drug products;...

  • The Validation Master Plan. Chatterjee, Bikash // Pharmaceutical Processing;Sep2011, Vol. 26 Issue 8, p14 

    The article describes the validation master plan (VMP) and three stages of the U.S. Food and Drug Administration's (FDA) new process validation guidance for pharmaceutical processing. It discusses the three stages of the process validation guidance including process design, process qualification...

  • Are You Gambling With Your Next Inspection? Larsen, Julie // Contract Pharma;Nov/Dec2012, Vol. 14 Issue 9, p72 

    The article offers information on the 10 key questions to assess preparedness for a U.S. Food & Drug Administration (FDA) inspection. It mentions that one should be aware of the FDA inspection trends, review processes and correlate the preparation efforts with FDA trends, and address potential...

  • Time to Show Your Work …. Nair, Ajith // Pharmaceutical Processing;Aug2012, Vol. 27 Issue 7, p36 

    The article presents the author's views on how the U.S. Food and Drug Administration (FDA) guidelines on manufacturing process validation are relevant to pharmaceutical packaging. He states that the guidelines reflects the agency's desire for a robust manufacturing process. He adds that the FDA...

  • FDA's Process Validation Guidance. Calcott, Peter // Pharmaceutical Processing;Aug2012, Vol. 27 Issue 7, p42 

    The article presents the author's views on the U.S. Food and Drug Administration's (FDA) process validation guidance which was issued in 2011. He examines whether the guidance has created traction or whether the pharmaceutical industry is still unsure of what to do with it. He comments that the...

  • FDA getting tougher on drug makers.  // Medical Marketing & Media;Aug2001, Vol. 36 Issue 8, p30 

    Presents the stand of the U.S. Food and Drug Administration toward failure of drug makers to comply with good manufacturing practices regulations. Issuance of Warning Letter to violators; Citation of severe regulatory actions; Application of the disgorgement of profits remedy.

  • The Means to Monitor Chemical Migration. Greb, Erik // Pharmaceutical Technology;Jun2011, Vol. 35 Issue 6, p40 

    The article discusses the means to monitor chemical migration in relation production processes in the U.S. It notes that the good manufacturing practice (GMP) and the Food and Drug Administration (FDA) regulations need pharmaceutical firms to know their production processes. The article also...

  • Nanotech task force releases report.  // Drug Topics;8/6/2007, Vol. 151 Issue 15, p6 

    The article focuses on the report released by the U.S. Food and Drug Administration's (FDA) Nanotechnology Task Force which advises FDA to develop guidelines for the use of nanoscale materials. The report stated the need for the agency to develop guidelines for manufacturers and researchers...


Read the Article


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

Try another library?
Sign out of this library

Other Topics