23-Jan-2017 - The EDQM has set out how it will integrate risk-based elemental impurities testing into the European Pharmacopoeia.
18-Jan-2017 - Suzhou Pharmaceutical Technology faked quality documents, shipped a banned supplier's API to the US and failed to store materials properly according to the US FDA.
17-Jan-2017 - Siemens and GEA have developed a continuous manufacturing platform for pharmaceuticals that integrates the former’s quality control software.
16-Jan-2017 - Industry groups have reiterated calls for UK drug approval and safety laws to be kept in line with EU rules, arguing that consistency benefits governments and patients Europe-wide.
12-Jan-2017 - The US FDA has finalised its guidelines on cGMP and quality system compliance for drug and delivery device combination products.
11-Jan-2017 - High frequency radiation can be used to test tablet quality and structural characteristics on the production line according to scientists planning to develop low cost THz sensors.
04-Jan-2017 - A Wockhardt facility in India put under import alert last year has received a US FDA warning letter citing issues ranging from data discrepancies to inappropriate aseptic clothing.
22-Dec-2016 - Cytobioscience Inc, has acquired Soluble Therapeutics Inc to expand its high throughput formulation screening capabilities.
20-Dec-2016 - Spanish regulators have found problems at a facility operated by immunotherapy producer Laboratorio Angulema.
14-Dec-2016 - Newly identified impurities in sugar excipients pose a risk to patients and could explain why some drugs fail safety tests according to scientists from the Netherlands.
14-Dec-2016 - The US FDA has criticized Pocono Coated Products' (PCP) efforts to bring its transdermal patch plant in Cherryville, North Carolina into compliance with cGMP standards.
13-Dec-2016 - The US FDA has given Akorn Pharmaceuticals' facility in Decatur, Illinois a clean bill of health after a re-inspection last week.
12-Dec-2016 - The US FDA has issued Indian API firm Alkem Laboratories Ltd. with a Form 483 after an inspection at is site in Ankleshwar, Gujarat.
12-Dec-2016 - Catalent has become the first CDMO to join the PSCI – a voluntary industry initiative focused on the social, environmental and economic impact of the supply chain.
07-Dec-2016 - The US FDA has issued Sun Pharmaceutical Industries with a Form 483 citing problems identified at its plant in Halol.
06-Dec-2016 - The US FDA has asked Spanish API firm Interquim S.A. for more details of its plan to bring its Barcelona manufacturing plant up to code.
01-Dec-2016 - Full transparency and open conversation with operators will lead to more successful facility audits, say regulatory experts.
28-Nov-2016 - The US FDA has cleared Lupin to restart production of drugs for the US market at its plant in Goa after the Indian firm fixed problems observed by agency inspectors.
24-Nov-2016 - The US FDA still has doubts about Srikem Laboratories’ plan to fix data integrity problems at its API manufacturing facility Taloja, India.
24-Nov-2016 - A written quality agreement between a sponsor and a contract manufacturer can facilitate compliance with cGMP, the US FDA says in its finalised guidance.
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