SUBSCRIBE

Breaking News on Global Pharmaceutical Technology & Manufacturing

QA/QC

News headlines

DISPATCHES FROM AAPS 2006

Excipient database: all systems go as US FDA clears backlog

16-Nov-2016 - The US FDA has almost cleared a backlog of 4000 excipient formulations in its Inactive Ingredient Database (IID) and wants drugmakers to help ensure ongoing accuracy.

Pfenex: consistently high manufacturing quality key for biosimilar success

15-Nov-2016 - Manufacturing quality is key for biosimilar success says Pfenex, as the US FDA continues to increase its regulatory oversight.

DISPATCHES FROM AAPS 2016

Pfizer and FDA: Expedited regulatory pathways ignore manufacturing burdens

15-Nov-2016 - The flexibility of clinical development for products on designated accelerated pathways is leading to at-risk investments in commercial manufacturing, say Pfizer and the FDA.

Precision meds and I-Phone microscopes: AAPS 2016 lands in Denver

14-Nov-2016 - AAPS 2016 kicked off yesterday with a focus on new technologies, new delivery modalities, accelerated drug development and precision medicines - oh and a microscope on an iPhone.

USP calls for industry feedback on proposed HPMC monograph

08-Nov-2016 - The USP has proposed monograph for hypromellose capsule shells used to make vegetarian friendly medicines.

EAG opens elemental impurities lab citing US FDA alignment efforts

08-Nov-2016 - EAG Laboratories has set up an elemental impurities lab in response to US FDA moves to align testing rules with ICH Q3D guidance and USP requirements.

Clarification

Endo pulls Patheon-made birth control pills in US over potency concerns

03-Nov-2016 - Endo International has withdrawn over half a million birth control pills made by contract manufacturer Patheon after tests indicated 

Lonza opens formulation development and testing lab

02-Nov-2016 - Lonza has opened a drug quality testing and formulation laboratory in Basel, Switzerland.

US FDA hits Chinese API maker with warning after having inspection impeded

02-Nov-2016 - Data integrity issues and the unexplained disappearance of drums of pharmaceutical ingredients have landed a Chinese API maker with a US FDA warning letter.

Sanofi and Regeneron mull FDA CRL after fill/finish plant hit with 483

31-Oct-2016 - The US FDA has issued a complete response letter for Sanofi and Regeneron’s rheumatoid arthritis candidate sarilumab due to manufacturing deficiencies at a fill/finish plant in France.

EC: EMA and US FDA GMP inspection deal could be agreed by January

27-Oct-2016 - Development of an EMA and US FDA mutual recognition agreement on drug facility inspections has progressed according to European Commission negotiators who say a deal could be signed by January.

US FDA still worried about Interpharm's efforts to stop API data manipulation

26-Oct-2016 - The US FDA wants more information on Czech API firm Interpharm Praha AS’s efforts to prevent repetition of data manipulation uncovered during 2015 inspection.

Biotrial says Le Figaro coverage of BIA 10-2474 trial is "smear campaign"

24-Oct-2016 - Biotrial has accused French newspaper Le Figaro of leading a “smear campaign” through its coverage of the Phase I trial in which one man died and five others were hospitalised in January. 

Laxachem Organics ban not linked to B. cepacia outbreak says US FDA

24-Oct-2016 - APIs made by Laxachem Organics pvt ltd were not the source of bacteria in Pharmatech laxatives linked to a spate of Burkholderia cepacia infections according to the US Food and Drug Administration (FDA).

Teva's troubled Godollo plant earns firm US FDA warning letter

20-Oct-2016 - The US FDA has warned Teva Pharmaceutical Industries about its facility in Godollo, Hungary over ongoing concerns about manufacturing operations.

Second Form 483 for Montana Compounding Pharmacy in two years

19-Oct-2016 - US FDA inspectors found vermin in drug production areas at a manufacturing facility operated by Montana Compounding Pharmacy.

US FDA publishes Akorn Pharmaceuticals' Form 483

19-Oct-2016 - The US FDA has identified quality control problems at a sterile drug manufacturing facility operated by Akorn Pharmaceuticals.

Recipharm commits SEK5m to bioanalysis lab citing lack of Nordic capacity

18-Oct-2016 - Recipharm has said it will spend SEK5m ($567,000) on a bioanalysis laboratory in Sweden citing the lack of capacity in the Nordic region as a driver for the investment.

WHO adds gatifloxacin to prequalification list to encourage API manufacturers

17-Oct-2016 - The WHO has added side-effect heavy, TB drug ingredient gatifloxacin to its prequalification list to encourage production.

FDA and CDC links B. cepacia outbreak to contamination at PharmaTech

13-Oct-2016 - The US FDA has found a direct link between contaminated water at CMO PharmaTech and a multistate B. cepacia outbreak.

Key Industry Events

 

Access all events listing

Our events, Shows & Conferences...

Product Innovation