07-Nov-2011 - Greater FDA oversight of US manufacturing plants increased the number of drug recalls in Q3 in a trend that is likely to continue according to a new report.
07-Nov-2011 - The EMA is to clarify when a product should be manufactured in a dedicated facility to avoid risk of cross contamination.
07-Nov-2011 - The US FDA has updated its ICH Q8, Q9 and Q10 question and answer document to clarify design space requirements.
24-Oct-2011 - Industry groups developing certification standards for third-party auditors of pharmaceutical excipient manufacturers say they are ready to launch the scheme next year.
20-Oct-2011 - Avantor is to offer tamper-evident seals on all its pharma raw material and excipient containers by the end of the year.
19-Oct-2011 - The FDA has sent GSK a GMP warning letter after finding failings in steps to prevent microbiological contamination at a UK site.
19-Oct-2011 - Canadian pharma manufacturers’ plan to stop drug shortages by sharing information fails to tackle underlying concerns, an analyst said.
18-Oct-2011 - Honeywell has introduced a high moisture barrier film to protect sensitive pharmaceuticals in hot and humid climates.
17-Oct-2011 - Spam filtering and identification is needed to stop Twitter becoming another platform for pushers of fake or substandard drugs, researchers say.
13-Oct-2011 - Sproxil and Orange have separately expanded text messaging anti-counterfeiting services in Kenya to tackle fake drugs.
13-Oct-2011 - The EMA may apply proposed porcine trypsin guidelines to existing products, such as a GSK vaccine, to cut viral contamination.
12-Oct-2011 - The US EPA plans to fine API manufacturer Rhode Technologies for alleged hazardous waste failings at its plant.
12-Oct-2011 - The FDA has published final guidance on the use of excipients as anti-counterfeiting tools in solid oral dosage forms.
11-Oct-2011 - The United States Pharmacopeial Convention (USP) has forged closer ties with Russian regulators to help tackle substandard pharmaceuticals and harmonize quality standards.
11-Oct-2011 - Sanofi Pasteur says it will regain lost ground in India through its new state-of-the-art vaccine manufacturing plant.
11-Oct-2011 - The Irish Medicines Board (IMB) has published guidance for cold-chain storage and transport of APIs and finished products.
04-Oct-2011 - The EMA is developing new vaccine quality guidelines in response to shortcomings seen during the influenza pandemic.
04-Oct-2011 - The US FDA may add product and violation-specific searches to its publicly available database of inspections as part of a transparency push.
03-Oct-2011 - SAFC will extend its focus on high potency production through a number of new investments.
03-Oct-2011 - The Australian TGA is considering adopting EMA guidance on residual solvents, genotoxic impurities and other GMP topics.
29-Sep-2011 - The US FDA has filed a permanent injunction against a US drugmaker and sent a warning letter to a Chinese API producer following cGMP problems.
28-Sep-2011 - The fall-out from Genzyme’s supply disruptions is still hindering Sanofi, more than five months after taking over the business.
26-Sep-2011 - Ukraine's parliament, the Verkhovna Rada, has voted unanimously in favour of new legislation which will criminalise the production and trafficking of counterfeit drugs.
22-Sep-2011 - PerkinElmer has launched its new Universal Operational Qualification (UOQ) service for pharmaceutical labs.
22-Sep-2011 - The FDA has issued a warning letter and import alert to an Indian API manufacturer after finding major cGMP failings.