Regulatory

Jan 01, 2005
BioPharm International
In order to institute a GxP mindset across the organization, support and respect for quality systems should come from the top down.
Nov 15, 2004
BioPharm International
There continues to be much interest within industry and FDA about the future of the GMPs. Discussion groups have been spawned within professional organizations and at FDA to reevaluate the aging GMPs and associated guidance documents to ensure that the government does not impede technological progress, focuses its resources effectively, and upholds its mandate to protect the public.
Nov 15, 2004
BioPharm International
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.
Nov 15, 2004
BioPharm International
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?
Nov 15, 2004
BioPharm International
What are current good manufacturing practices (cGMPs)? Where did they come from? What are the actual "practices" described in the Code of Federal Regulations, 21 CFR. If you are new to the pharmaceutical or biotechnology industries, you may enter your first "GMP Training" session without much context or perspective. A set of arcane rules is presented; you were never taught these in science classes.
Nov 01, 2004
BioPharm International
When replacing an existing method, it may be necessary to compensate for a significant difference between the current and new method by adjusting the specifications.
Oct 01, 2004
BioPharm International
The relationship between "valid" or "suitable and validated" is often overlooked, but there is a high price when "validated" test systems are simply inappropriate.
Sep 01, 2004
BioPharm International
By BioPharm International Editors
Filtration is one of the most commonly used unit operations in the manufacturing of biopharmaceuticals. This is the second part of the fourth article in the "Elements of Biopharmaceutical Production" series. In this second segment, Manoj Menon and Frank Riske present an approach for the development and optimization of a TFF application, followed by a contribution from Jennifer Campbell and Elizabeth Goodrich reviewing key issues involved in validation of a TFF step.
Aug 01, 2004
BioPharm International
Filtration is one of the most commonly used unit operations in biopharmaceutical manufacturing. Available formats include direct or normal flow filtration (NFF) and cross or tangential flow filtration (TFF). These methods are used for sterilization and virus filtration, depth filtration or ultrafiltration, and diafiltration applications. Some common objectives include:
Jul 01, 2004
BioPharm International
Although there are many differences between the industries, especially related to regulatory requirements, there are enough similarities that the future of biopharmaceuticals with respect to contract manufacturing might look much like the semiconductor industry.
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