QA/QC

FINANCIAL REPORT

Thermo Fisher's cautiously optimistic outlook for 2017

02-Feb-2017 By Dani Bancroft

Thermo Fisher Scientific, Inc. saw revenue grow 8% in 2016, mostly due to acquisitions of new Chromotography and mass spectrometry tech and expanding its Bioproduction.

Chinese CDMO group buys New Jersey J-STAR for $26m

02-Feb-2017 By Dani Bancroft

A US-subsidiary of the Chinese CDMO Porton Fine Chemicals Ltd. has bought the New Jersey based small molecule API contract research organisation, J-STAR Research, Inc. 

AEMPS slams QC systems at Euro Far Alergi plant

01-Feb-2017 By Gareth Macdonald

Spanish regulators have criticised operations at a facility operated by vaccine firm Euro Far Alergi S.L.

US FDA calls CTX Lifesciences' plant remediation plan inadequate

01-Feb-2017 By Gareth Macdonald

The US FDA has asked CTX Lifesciences PVT Ltd for more details of how it will bring its API plant in India up to code.

Shredded records and unofficial spreadsheets land Italian plant with FDA warning

31-Jan-2017 By Dan Stanton

Data integrity issues have landed Italian drugmaker FACTA Farmaceutici with a US FDA warning letter.

Italy bans antibiotic APIs made by Antibioticos do Brasil

31-Jan-2017 By Gareth Macdonald

Italy has banned APIs made by Antibioticos do Brasil LTDA (ABL) at its facility in Bairro Itapavussu, Sao Paulo over sterility concerns.

GMP-status 'a major step' for medical marijuana recognition, Bedrocan

26-Jan-2017 By Dan Stanton

The GMP certification of a Dutch cannabis production facility is a “major step” in bringing medicinal marijuana to the level of evidence based medicines, says Bedrocan.

J&J buying Actelion for $30bn, but should CMOs be concerned?

26-Jan-2017 By Dan Stanton

With no production sites of its own, we question whether Johnson & Johnson’s manufacturing network is likely to incorporate Actelion’s substantial product portfolio.

Ocular Therapeutix has resubmitted Dextenza to US FDA after CRL

23-Jan-2017 By Gareth Macdonald

Ocular Therapeutix Inc. has resubmitted its eye pain drug Dextenza to the US FDA claiming it has solved manufacturing problems that saw the agency reject the drug in July.

EDQM outlines ICH Q3D impurities testing guideline integration plan

23-Jan-2017 By Gareth Macdonald

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Dan Stanton

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 By Gareth Macdonald

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 By Dan Stanton

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 By Staff Reporter

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 By Gareth Macdonald

Spanish regulators have found problems at a facility operated by immunotherapy producer Laboratorio Angulema.

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

14-Dec-2016 By Gareth Macdonald

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.

update

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

14-Dec-2016 By Gareth Macdonald

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 OKs Akorn plant after re-inspection

13-Dec-2016 By Gareth Macdonald

The US FDA has given Akorn Pharmaceuticals' facility in Decatur, Illinois a clean bill of health after a re-inspection last week. 

Alkem issued with Form 483 by US FDA

12-Dec-2016 By Gareth Macdonald

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 By Dan Stanton

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Dan Stanton

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Dan Stanton

A written quality agreement between a sponsor and a contract manufacturer can facilitate compliance with cGMP, the US FDA says in its finalised guidance.

US FDA calls Wockhardt efforts to fix Wrexham plant 'inadequate'

22-Nov-2016 By Gareth Macdonald

Efforts by Wockhardt to fix violations at drug plant in Wrexham, Wales are inadequate according to the US FDA which detailed its concerns in a warning letter this week.

Sanofi Pasteur confirms plant problems prompted TheraCys decision

22-Nov-2016 By Gareth Macdonald

Sanofi Pasteur has confirmed the decision to stop making the bladder cancer drug TheraCys was prompted by long running problems at the Toronto manufacturing plant where it is made.

DISPATCHES FROM AAPS 2006

Excipient database: all systems go as US FDA clears backlog

16-Nov-2016 By Dan Stanton

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.

DISPATCHES FROM AAPS 2016

Pfizer and FDA: Expedited regulatory pathways ignore manufacturing burdens

15-Nov-2016 By Dan Stanton

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.

Pfenex: consistently high manufacturing quality key for biosimilar success

15-Nov-2016 By Dan Stanton

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

USP calls for industry feedback on proposed HPMC monograph

08-Nov-2016 By Gareth Macdonald

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Dan Stanton

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 By Dan Stanton

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Staff Reporter

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Dan Stanton

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