Regulatory & Industry Guidance

For Pharmaceutical/Bio-Pharmaceutical or Vaccines products manufactured under a current good manufacturing practice (cGMP) environment, the intent of the Computer Systems/Computer Validation handbook is to outline the major regulatory guidelines by US Food and Drug Administration, European Medicines Agency (EMA) and other regulatory agencies.
Amjad Ganma
Microbiology has a clear impact upon the pharmaceutical industry, and regulatory authorities are keen to ensure that medicinal products of all kinds are controlled with regard to potential contamination of products by microorganisms. Pharmaceutical microbiology ensures medications not to contain harmful levels of microorganisms. Regulations exist...
John E. Lincoln
Software verification / testing and validation (SW V&V) in the regulated environment has different goals from software V&V in code development and testing. The author generally defines verification as testing, inspection, and/or checking conformance of some element(s) to a check list, and validation as the complete package of verification...
Harry Yang
Stability of a drug product is a critical quality attribute. It plays a very important role in the life cycle of the product. Stability studies are conducted during development, licensure, and post-marketing phases to ensure product quality through its shelf life. Regulatory agencies around the globe in general require an expiration dating period...
Eugenie Webster (Khlebnikova)
Analysis and control of variation play an important role in pharmaceutical manufacturing. Since each product has some degree of variation, the variation must be controlled to ensure quality, safety, and efficacy. Statistical tools to analyze and control variation can be used from drug development to routine manufacturing. The guidance...
Dissolution testing has emerged as an important tool to characterize drug product performance in the pharmaceutical industry. The significance of this test is based on the fact that the rate and extent of drug absorption depend on the dissolution of the drug substance from the dosage form. Therefore, dissolution testing is performed not only for...
Corrective Action Preventive Action programs are especially designed to maximize efforts devoted to the investigation and correction of quality issues and to prevent recurrence. In 1962, the US Congress instructed the Food and Drug Administration (FDA) to require that all drugs be produced according to Good Manufacturing Practice (GMP) which...
Amjad Ganma
In order to ensure the quality and reliability of data produced by a laboratory, it is necessary to use a systematic method of qualifying and calibrating the instruments in a way that is appropriate for the type of instrument and which takes the type of use into consideration. Because reliable data is a key component of GMP, it is covered...
Allan Marinelli
For Pharmaceutical/Bio-Pharmaceutical or Vaccines products manufactured under a cGMP [Current Good Manufacturing Practice ]environment, the intent of the Heating, Vent and Air Conditioning handbook is to outline the major regulatory guidelines by FDA [United States Food and Drug Administration], EMA [European Medicines Agencies] and/or other...
Laure Larkin
Test method validation is an often confusing requirement for medical devices. The medical device industry has long understood the need for validation of processes, equipment and software. This understanding results from the fact the regulating agencies have clearly used the above terms in conjunction with the phrase “validation” in the...
Benjamin Frey
With the increased pressures of cost control for manufacturers of FDA-regulated products and the rapid expansion of globalization of the supply chain, the expectations of manufacturers and sponsors to control activities and materials provided by their suppliers has been magnified. It is the responsibility of each organization to ensure that their...
Adeana Dorsey
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David Fetterolf
Process validation involves data collection and evaluation utilizing a life-cycle management approach from design through production based on scientific evidence that a process is consistently capable of delivering quality product. The regulatory expectation of process validation has shifted the meaning of Process Validation to encompass...

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