Quality Assurance Articles

A water distribution plan is at the heart of an overall energy and water conservation program.

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Janet Rose Christensen
BioPharm International, November 2004 Good manufacturing practices (GMPs) are manufacturing guidelines for ensuring the safety and efficacy of drug products and medical devices. The GMPs are legal regulations, based o­n the United States Food, Drug and Cosmetic Act. But, why do we need the GMPs? Shouldn't we, as knowledgeable individuals, groups, and companies, be able to figure out how to produce drugs and devices that are safe and effective?

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The future is now for manufacturers of Active Pharmaceutical Ingredients (APIs) with the publication of the Q7A Guidance for Good Manufacturing Practice. San Juan, Puerto Rico was the site for a comprehensive workshop, sponsored by the Parental Drug Association (PDA), Generic Pharmaceutical Association (GphA), Pharmaceutical Research and Manufacturing Association (PhRMA), and the U.S. Food and Drug Administration (FDA). This workshop had two main goals: to introduce the basic concepts of the Q7A guidance, and to offer a glimpse of the rationale and intent of the designers of the document as it applies to API.

This column discusses potential sources and ways to avoid out-of-specification (OOS) results and highlights the draft FDA guidelines o­n OOS investigations.

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An extended survey was conducted o­n the topic of clinical quality assurance (CQA) benchmarking in pharmaceutical companies to gather new data.


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When building a biotech manufacturing facility and a QC lab, which scenario do you choose — build manufacturing first, build the QC lab first, or build both facilities simultaneously?

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GMP is the acronym for Good Manufacturing Practice. The GMPs represent a set of regulations that were promulgated as a final rule by FDA in 1978 and intended to ensure the safety and efficacy of the nation's drug products. The GMPs, as we know them today, are the result of over a century of actions by industry and reactions by government and consumer groups to bring guidance and controls to the food and drug industry, resulting in a safe supply of food and medicines.

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EPA can now hold industry's environmental toes to the test of "any credible evidence" (ACE), as opposed to procedures found in the Code of Federal Regulations. And industry doesn't seem to like it  There is an old proverb that states "...be careful what you wish for, you might get it." In complying with new air quality regulations, industry may find itself reflecting on that old chestnut. Historically, EPA told industry exactly what to monitor and when to monitor for drinking water, wastewater, air, and so forth. Now, at least for air, these edicts from EPA are changing. Instead of imposing monitoring requirements on industry, EPA is allowing industry to tell the agency what each plant will monitor and how such monitoring will ensure that a given plant site is operating within its allowable limits.

“GMP in R&D Working Group” members of the APIC (CEFIC)

The author describes the efforts of the standards committees to establish guidelines for Process analytical technology (PAT) implementation and the impact of the guidelines o­n the industry.