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QA/QC

News headlines

EDQM outlines ICH Q3D impurities testing guideline integration plan

23-Jan-2017 - The EDQM has set out how it will integrate risk-based elemental impurities testing into the European Pharmacopoeia.

US FDA slams Suzhou Pharmaceutical Technology for copy and paste CoAs

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. 

GEA and Siemens team on continuous processing tech

17-Jan-2017 - Siemens and GEA have developed a continuous manufacturing platform for pharmaceuticals that integrates the former’s quality control software.

EFPIA and ABPI urge UK to keep drug regs consistent with EU post Brexit

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.

US FDA finalises combination drug/device product guidance

12-Jan-2017 - The US FDA has finalised its guidelines on cGMP and quality system compliance for drug and delivery device combination products.

T-ray technique faster for tablet quality and structure testing say researchers

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. 

Data integrity and aseptic issues land Wockhardt with FDA warning

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.

CytoBioscience buys formulation safety tech company in Alabama for millions

22-Dec-2016 - Cytobioscience Inc, has acquired Soluble Therapeutics Inc to expand its high throughput formulation screening capabilities.

Laboratorio Angulema warned by Spanish regulators about Leganes plant

20-Dec-2016 - Spanish regulators have found problems at a facility operated by immunotherapy producer Laboratorio Angulema.

update

Sugar lumps? Excipient impurities may be risk to patients says researcher

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.

US FDA slams delivery patch firm Pocono Coated Products over sub-potent meds

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.

News in brief

US FDA OKs Akorn plant after re-inspection

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. 

News in brief

Alkem issued with Form 483 by US FDA

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.

Catalent joins industry group supply chain initiative

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.

Troubled Halol plant earns Sun a US FDA Form 483

07-Dec-2016 - The US FDA has issued Sun Pharmaceutical Industries with a Form 483 citing problems identified at its plant in Halol.

US FDA says Interquim's API plant remediation plan is inadequate

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.

Operator silence rings alarm bells during audits, say FDA and WHO experts

01-Dec-2016 - Full transparency and open conversation with operators will lead to more successful facility audits, say regulatory experts.

US FDA clears Lupin to supply US with meds made in Goa

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.

US FDA says Srikem plan will not fix data integrity issues at Taloja plant

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.

US FDA finalises contract manufacturing quality agreement guidance

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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