March 14th 2025
The certification allows Benuvia to produce pharmaceutical products for companies, either local to Brazil or international, that may be looking for compliant and high-quality production capabilities in the Brazilian pharmaceutical market.
FDA's Justina A. Molzon on ICH and Harmonization
December 3rd 2009Pharmaceutical Technology talks to FDA's Justina A. Molzon about current discussions with international regulators, and how, after 20 years of harmonization activities and the common technical document, ICH has benefited regulatory authorities.
Medicines top consumers' counterfeit concern list
November 27th 2009Five per cent of consumers across five European countries suspect they may have received a counterfeit prescription and 1% believe that they definitely have, according to research conducted by ICM on behalf of patient safety communications company Aegate (UK).
European Consumers Call for Tougher Counterfeit Measures
November 25th 2009Five percent of consumers across five European countries suspect they may have received a counterfeit prescription, and 1% believe that they definitely have, according to research conducted by ICM on behalf of patient safety communications company Aegate (UK).
SOCMA Hails FDA Action on Citizen Petition Regarding Inspections
November 5th 2009The Society of Chemical Manufacturers and Affiliates (SOCMA) reported last week that the US Food and Drug Administration responded to the association's citizen petition relating to the inspection process of foreign drug-manufacturing facilities.
ICH Adopts Pharmacopeial Text Annexes and Prepares for Global Quality Implementation
November 5th 2009Last week, the steering committee and expert working groups of the International Conference on Harmonization (ICH) met in St. Louis, Missouri. A major success of the meeting was the adoption of several annexes to ICH Q4B on pharmacopeial texts.
Position Paper: Are We Abandoning IQ and OQ?
November 2nd 2009The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment."