13-Jul-2011 - Congress must grant the FDA additional powers to bring oversight of manufacturing inline with shifts in production practices, according to a report.
11-Jul-2011 - Production plants exceeding emission levels could have manufacturing authorisations revoked under EU GMP proposals made by Sweden.
11-Jul-2011 - Eli Lilly has called for law enforcement to find and dismantle the supply sources and distribution networks underpinning fake online pharmacies.
07-Jul-2011 - The FDA has sent a warning letter to Cadila Healthcare’s Ahmedabad, India finished products plant after an inspection found GMP deviations.
07-Jul-2011 - Tylenol Extra Strength Caplets yesterday became the latest in a long succession of Johnson & Johnson products to be pulled from the shelves after complaints of the pills’ “musty odor”.
04-Jul-2011 - The USP has published a free, online collection of standards to support drug quality, particularly where regulatory resources are limited.
28-Jun-2011 - Australia’s CSL Biotherapies has received a warning letter from the US FDA for GMP deviations at its vaccine production plant in Parkville, Victoria.
07-Jun-2011 - US generics maker Impax Laboratories says it has started addressing cGMP deviations observed by regulators at California manufacturing plant.
31-May-2011 - Chinese authorities have arrested hundreds of people accused of manufacturing and selling fake pharmaceuticals in the country’s Zhejiang province.
30-May-2011 - The US Food and Drug Administration (FDA) has published a list of all the drug manufacturing facilities it has inspected between October 2008 and September 2010 as part of Government transparency efforts.
25-May-2011 - US drug giant Pfizer is investing in additional sterile manufacturing capacity at its facility in Portage, Michigan
24-May-2011 - in-PharmaTechnologist presents a round up of current good manufacturing practice (cGMP) related warning letters sent by the FDA in recent months.
24-May-2011 - Fears the US FDA is mismanaging oversight of J&J in Puerto Rico are “deeply troubling”, said a US Congressman.
19-May-2011 - The EDQM has revised its policy on withdrawal of API or excipient certification to clarify the appeal process.
18-May-2011 - The Australian Therapeutic Goods Administration (TGA) has introduced a new mechanism to help drugmakers maintain evidence of GMP compliance at manufacturing facilities outside the country.
12-May-2011 - EMD Millipore has opened a training facility in China as an education resource for the country’s rapidly expanding biopharmaceutical manufacturing and development sector.
12-May-2011 - Quality issues slowed first quarter revenue growth at Teva but, with one plant resuming shipping and another awaiting re-inspection, sales are expected to pick up.
10-May-2011 - The FDA and USP have expanded their collaboration to ensure the quality of medicines by modernising tests and standards.
09-May-2011 - Carbogen Amcis’s Indian plant has met industrial standards for the containment and handling of highly potent active pharmaceutical ingredients (HPAPI).
02-May-2011 - Strides’ oncology plant in Bangalore, India has been approved by the FDA, positioning the company to enter the US market.
27-Apr-2011 - The United States Pharmacopeial Convention (USP) and the Chinese Pharmacopoeia Commission (ChP) have made mutual executive appointments in an effort to further align drug quality standards.
27-Apr-2011 - Teva has resumed production at its Irvine, California plant a year after quality control issues put production on hold.
26-Apr-2011 - Tablet testing tech specialist Sotax has set up a new unit in India in the first stage of a five year plan to expand its business in the country.
14-Apr-2011 - FDA Commissioner Hamburg has asked for more supply chain security and quality control regulatory powers.
13-Apr-2011 - New powers and a budget increase, despite cuts to government spending, have been proposed to help the FDA monitor the global supply chain.