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QA/QC

News headlines

IPEC-Americas aims to make drug excipient users TUPP aware

15-Dec-2014 - Manufacturers should profile the "black specks" created during excipient production and share details with customers according to guidance finalised by IPEC-Americas, which says the unavoidable particles are starting to earn drugmakers 483s.

From CPHI India

IPA says bad inspectors making Indian manufacturers fear visits

11-Dec-2014 - The Indian Pharmaceutical Alliance says the quality of US FDA inspections has “significantly deteriorated” this year, and their approach is creating a climate of fear among Indian manufacturers.

Sun closes in on Ranbaxy deal with CCI approval

10-Dec-2014 - The Competition Commission of India (CCI) has approved Sun Pharma’s $3.2bn acquisition of Ranbaxy.

From CPHI India

CPHI India: experts say ‘data fraud’ dragging down Indian manufacturing

09-Dec-2014 - Experts at CPHI India say companies failing manufacturing inspections need to be more honest with their data.

From CPHI India

Eager-to-please Indian manufacturers creating GMP chaos says expert

08-Dec-2014 - Cultural differences and broken promises are behind Indian GMP failures and acute generics shortages in the UK, according to one pharmaceutical distributor.

FDA to allow paper or electronic transaction info transfers under DSCSA

08-Dec-2014 - New draft guidance from the US FDA related to track-and-trace legislation facilitates the transfer of both paper and electronic accounts of transaction info, history and statements for manufacturers, repackagers and wholesale distributors.

Flu vaccine underwent 35 QA/QC tests in Italy death probe, says Novartis

05-Dec-2014 - Novartis has spoken about the extensive safety testing at its production sites after its seasonal flu vaccine Fluad was found to be unconnected to 19 deaths in Italy.

From CPHI India 2014

Do you manufacture these APIs? ‘We’re interested in you,’ says WHO

04-Dec-2014 - The World Health Organisation says its prequalification scheme gives free help to makers of selected APIs, drugs and vaccines who want to boost their standards and access international markets.

German regulators hit Ranbaxy with another warning letter

03-Dec-2014 - Another warning letter has landed in the hands of Ranbaxy execs, this time from German regulators charging the company with failing to comply with GMP standards.

EMA seeking drugmaker feedback on cyclodextrin and propylene glycol labelling plan

03-Dec-2014 - The EMA has called for feedback on plans to require drugmakers to state whether their drugs contain solubility-enhancing cyclodextrin excipients.

Dr Reddy's API plant receives USFDA 483 with nine observations

27-Nov-2014 - Dr Reddy’s says an API plant in India is unlikely to be subject to further regulatory enforcement after receiving a US FDA 483 with nine observations.

Chinese excipient market set to more than double by 2017

26-Nov-2014 - With more than 90 excipient manufacturers in China dedicated to the pharma industry, the country expects its output of excipients to more than double to about $8.9bn (€7.1bn), according to a new report.

EMA adopts guidelines on phthalate excipients, cross-contamination in manufacturing

25-Nov-2014 - The two guidelines offer help to manufacturers looking to use potentially hazardous phthalates as excipients in drugs, as well as those that have shared facilities where multiple drugs are produced.

US, Chinese regulators forge closer ties as FDA looks to triple staff

24-Nov-2014 - As FDA commissioner Margaret Hamburg wraps up her trip in China it looks like the FDA is creating a stronger bond with its Chinese counterparts as the FDA looks to triple its staff there.

MHRA says quality system deficiencies are most common issue from inspections

20-Nov-2014 - Deficiencies related to manufacturers’ quality systems are by far the most prevalent issue cited from inspections by the UK’s MHRA (Medicines and Healthcare Products Regulatory Agency), the agency said in a report on 2013 inspections .

US FDA calls out two companies over fake Ebola treatments

20-Nov-2014 - The US FDA and the Federal Trade Commission have sent warning letters to two companies claiming to have drugs that treat Ebola though no such product has been approved by the agency.

Questions raised over new $2.6bn price tag to bring a new drug to market

19-Nov-2014 - The Tufts Center for the Study of Drug Development is out with a new study claiming that the average cost of bringing a new drug to market is around $2.6bn, though some are saying that number seems inflated.

Expert cautions: DSCSA deadlines may cause drug shortages

18-Nov-2014 - Drug shortages could be an issue in the near future as some wholesale distributors and drug suppliers may not be able to meet a key Jan. 1 deadline from the Drug Supply Chain and Security Act (DSCSA), an expert says.

FDA commish in China in search of more facility inspector visas

18-Nov-2014 - US FDA commissioner Margaret Hamburg is traveling to China this week and at least part of her trip will be devoted to securing visas for new drug manufacturing site inspectors.

'Killer experiments' and reimbursement are the keys to VC backing says Index

17-Nov-2014 - Investors only back drug innovators because they have to according to Index Venture Management's Kevin Johnson, who says less risky 'first to be second' firms are much more attractive.

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