Regulatory

Apr 01, 2005
BioPharm International
By BioPharm International Editors
Biotechnology and life sciences companies come in all shapes and sizes. Some are multinational companies with vast resources and others are small companies working with a few new compounds. Regardless of size or market position, these companies should all have one common question of those that handle their insurance: Will their current insurance program protect their assets and investments in the event of a significant loss? Understanding the nature of risks, acquiring suitable insurance, and comprehending policy issues when claims arise are essential to protecting assets and obtaining reimbursement when losses occur.
Mar 01, 2005
BioPharm International
The purpose of design validation is to demonstrate that a product performs as intended. The usual route to this goal is showing that every item on the specification has been achieved, but it is not an easy path. The specification itself can create difficulty if it includes statements like "as long as possible" or the real horror "to be decided." Verification tests can reveal so many problems that the design must change to such an extent that earlier tests are no longer relevant. And there is also the practical difficulty of obtaining sufficient samples to test when the manufacturing engineers have not completed their standard operating procedures, the product design is not fixed yet, the component suppliers are late, and the marketing department has taken all the samples to show to prospective customers.
Mar 01, 2005
BioPharm International
RARM procedures don't exist in a vacuum. For people to perform effective and useful RARMs, the process needs to be integrated with other GMP quality system elements and be proceduralized.
Mar 01, 2005
BioPharm International
Many types of equipment in both manufacturing and laboratory areas are critical to a properly functioning pharmaceutical process. The validation of laboratory equipment is not as clearly defined as the validation of equipment used directly in the production of pharmaceutical products, which requires thorough validation in almost all situations.
Mar 01, 2005
BioPharm International
Synthetic drugs can be well characterized by established analytical methods. Biologics on the other hand are complex, high-molecular-weight products, and analytical methods have limited abilities to completely characterize them and their impurity profiles. Regulation of biologics includes not only final product characterization but also characterization and controls on raw materials and the manufacturing process.
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.
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