Tag Archives: USP

Drug Regulators, FDA – CDER, Publish Guidance on Use of Mechanical Calibration of Dissolution Apparatus CGMP

Posted on February 6, 2010 by admin| Leave a comment

Drug Regulators, FDA – CDER, Publish Guidance on Use of Mechanical Calibration of Dissolution Apparatus CGMP

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This guidance is intended to aid drug manufacturers (including ancillary testing laboratories) in calibrating U. S. Pharmacopeia (USP) Dissolution Apparatus 1 and 2 to help assure that critical parameters associated with the dissolution apparatus meet certain mechanical calibration (MC) tolerances. This guidance recommends that an enhanced MC procedure (such as the one recommended in this guidance) can be used as an alternative to the current Apparatus Suitability procedure for Dissolution Apparatus 1 and 2 described in USP General Chapter <711> Dissolution. Regardless of whether the enhanced MC procedure or Apparatus Suitability procedure is used, the guidance also recommends that appropriate measures be taken to control the following sources of significant variability in dissolution testing: dissolved gases, vibration, and vessel dimensions.

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Drug Regulators, FDA, Publish Guidance for Industry on Residual Solvents in Drug Products Marketed in the USA

Posted on December 29, 2009 by admin| Leave a comment

Drug Regulators, FDA, Publish Guidance for Industry on Residual Solvents in Drug Products Marketed in the USA

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This guidance is intended to assist manufacturers in responding to the issuance of the United States Pharmacopeia (USP) requirement2 for the control of residual solvents in drug products marketed in the United States. Specifically, this guidance makes recommendations on the following:
1. How new drug application (NDA) and abbreviated new drug application (ANDA) applicants for noncompendial drug products should limit residual solvents as described in the International Conference on Harmonisation (ICH) guidance for industry Q3C Impurities: Residual Solvents (Q3C). This guidance contains recommendations on solvent classification and permitted daily exposure.3
2. How manufacturers of compendial drug products that are not marketed under an approved NDA or ANDA can comply with USP General Chapter <467> “Residual Solvents” and the Federal Food, Drug, and Cosmetic Act (the Act).
3. How holders of NDAs or ANDAs for compendial drug products should report changes in chemistry, manufacturing, and controls specifications to FDA to comply with General Chapter <467> and 21 CFR 314.70.
For recommendations on solvent classification and permitted daily exposure, please refer to the ICH Q3C.

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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