In response to a flood of requests over uncertainties regarding ICH Q7 guidance, the international consortium recently released a question and answer (Q&A) document intended help companies implement appropriate GMPs (good manufacturing practices)...
Health Canada is telling drug and API manufacturers that it’s going to ramp up announced and unannounced inspections due to concerns raised around APIs and data integrity, and the findings will be published online beginning next month.
Sponsors trialling drugs in Asia should insist on the highest manufacturing standards and consider local production to successfully navigate the varied and complex regulations that govern research in the region says Almac.
Onyx Scientific, a UK contract development and manufacturing organisation (CDMO) has completed an API (active pharmaceutical ingredient) production deal for Neuronascent, a US company developing neurological therapies.
Patheon hopes that a new pharmaceutical development services (PDS) suite at its facility in Whitby, Ontario will complete its “Quick to Clinic” offering and provide a rapid-response means of making solid dosage forms for trials.
Ranbaxy’s antiretrovirals zidovudine, lamivudine, and nevirapine have been removed from PEPFAR’s list of approved products until ongoing GMP problems at two of the firm’s Indian manufacturing plants are resolved.
Sancilio & Co (SCI) says that its new contract manufacturing plant in Riviera Beach, Florida can provide pharmaceutical manufacturers with small batch production capacity for drug tablets and capsules.
The US Food and Drug Administration (FDA) has relaxed the regulatory good manufacturing practice (GMP) rules for drugs in early-stage clinical trials in recognition of the different requirements of trial scale and industrial scale manufacture.
Auditing firm blue inspection body (BIB) has achieved a type 'A'
independence rating under German accreditation organisation DAP's
scheme to certify the third-party inspection of active
pharmaceutical ingredient (API)...
Screening and processing equipment supplier Kason, were out in
force at InterPhex 2006, with a range of products that aid the
manufacturing industry meet stringent pharmaceutical sanitary
Information technology giant IBM has developed a software
architecture that promises to modernise the pharmaceutical
industry's manufacturing processes, often accused of lagging behind
those of other industries such as chemicals...
Cambridge Major Laboratories expects to complete construction of a
new process R&D and manufacturing facility in the middle of
2004 that will make it one of the largest Good Manufacturing
Practice (GMP) development and small-scale...
The US Food and Drug Administration is gearing up for the first
major overhaul of its current Good Manufacturing Practice
guidelines in 25 years, according to the agency's Commissioner Mark
McClellan. The move is just one strand...