Regulatory/GMP Compliance

Feb 01, 2005
BioPharm International
By BioPharm International Editors
One of the critical early tasks of the documentation team is coordinating plans and requirements with the start-up team.
Feb 01, 2005
BioPharm International
By BioPharm International Editors
In most production environments, it is critical to be able to associate historical environmental data with process data.
Feb 01, 2005
BioPharm International
By BioPharm International Editors
Organizations can mitigate the risk of failure during regulatory inspections by identifying and correcting deficiencies before an inspection occurs.
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.
Jan 01, 2005
BioPharm International
By BioPharm International Editors
Manufacturing changes — such as changes in formulation or source material — can impact a product’s immunogenicity.
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.
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