6.3. Good Manufacturing Practices (GMP) Good Manufacturing Practices (GMP) dictate the manufacturing processes, quality control, and quality assurance standards for pharmaceutical products. Pharmaceutical foil manufacturers must adhere to GMP guidelines to ensure the safety, efficacy, and quality of their ...
the Food and Drug Administration (FDA) deals with both categories. More recently, the FDA has defined a new “live biotherapeutic products” (LBP) category, clarifying pharmaceutical expectations. Since 2019, the quality requirements for this category of drug products have also been clarified by th...
Applicability of Standards requires excipients recognized in USP–NF to be prepared according to recognized principles of GMP [good manufacturing practice] and from ingredients complying with specifications designed to ensure that the resultant substances meet the requirements of the compendial monographs. ...
Part 210– Current GMP, Manufacturing, Processing, Packing, or Holding of Drugs: Contains the minimum current good manufacturing practice for methods to be used in the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requiremen...
Oral Delivery of Biologic APIs: The Challenge Continues Covering Global Regulations in a Quality System Risk-Based Predictive Stability–An Industry Perspective Quality Agreements:Managing Global Relationships Achieving Manufacturing Excellence GMP Facility Modernization: Opportunities for Successful Implementation ...
Polymeric nanoparticles turned out to have the potential to augment antiviral and antiproliferative effects of purine derivatives by specific binding to receptors (ASGR1—liver, macrophage mannose receptor), increase in drug retention (in eye, intestines, and vagina), and permeation (intranasal to ...
GMP certifications were formed as an extension of FDA approval for products. 1962 was the year in which the FDA introduced drug amendments and the formalized certification known as the GMP. Since 1962 the certification has been amended numerous times in response to large-scale events, with one ...