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QA/QC

News headlines

Novartis aims to save $1bn by 2020 with integrated manufacturing plan

26-Apr-2016 - The savings will come from centralising manufacturing services and will complement the firm’s cost-saving business division launched last year.

WHO says Semler Research manipulated data and warns repeat studies may needed

25-Apr-2016 - The WHO has accused Semler Research of data fraud and said Mylan, Micro Labs, Lupin and Strides and others may need to repeat bioanalytical trials conducted by the CRO.

US FDA hits another Indian drugmaker over data integrity issues

21-Apr-2016 - Sri Krishna Pharmaceuticals has been hit with a warning letter after the US FDA found problems with quality data at a site in Hyderabad, India.

WHO removes TB and malaria drug APIs made by Anuh Pharma from approved list

21-Apr-2016 - The WHO has removed two APIs supplied by Anuh Pharma from its list of prequalified ingredients and announced plans to inspect the firm’s facility in Boisar, India.

update

US National Cancer Institute stops making cell therapy in light of contamination risk

20-Apr-2016 - Cell therapy and radiotracer production has halted at two facilities operated by the US National Institutes of Health (NIH) after consultants raised concerns about quality and manufacturing standards.

News in brief

Alembic Indian plant hit with US FDA Form 483 and four observations

19-Apr-2016 - The US FDA has hit an Indian formulation facility run by Alembic Pharmaceuticals with a Form 483 with four observations.

US FDA guidance looks to stem ‘major problem’ of data integrity

18-Apr-2016 - The US FDA has issued draft guidance to address the recent torrent of data integrity problems at drug manufacturing sites.

update

Trade secret laws adopted by MEPs create legal uncertainty for pharma whistleblowers says HAI

14-Apr-2016 - Trade secret laws adopted by the European Parliament mean employees who raise concerns about drug safety and efficacy face legal uncertainty says HAI.

Spanish regulators suspend Inmunotek's manufacturing license and order recall

13-Apr-2016 - Inmunotek has been ordered to recall vaccines made at a facility in Madrid after Spanish regulators identified a number of GMP deficiencies.

IPCA Laboratories will not supply anti malaria meds to the Global Fund

11-Apr-2016 - IPCA has lost its supply agreement with the Global Fund just weeks after claiming to have “written confirmation” of an impending order.

Catalent: Limited production begins at suspended French softgel plant

04-Apr-2016 - Catalent has missed its forecast for bringing a suspended softgel facility back online, but says production of essential drugs has begun at the French plant.

Rusan Pharma plant still breaks GMP rules says UK MHRA

04-Apr-2016 - Quality systems at a plant run by Rusan Pharma still break GMP rules according to a MHRA statement of non-compliance published this week.

Catalent softgel plant hit with US FDA 483 while client Opko receives CRL

31-Mar-2016 - The US FDA says it will not approve Opko's kidney disease drug Rayaldee until contract manufacturer Catalent fixes problems at its softgel plant in Florida.

Revised water for injection monograph allows use of cheaper and greener alternatives to distillation

31-Mar-2016 - The European Pharmacopeia Commission has adopted a revised monograph that allows a broader range of purification methods to be used for the production of water for injectable pharmaceuticals.

Cadila Healthcare confirms WHO notice of concern in BSE filing

30-Mar-2016 - Cadila Healthcare has confirmed receipt of a notice of concern (NOC) about its vaccine plant in Moraiya, India five months after the WHO inspectors criticized operations.

French regulators report GMP failings at Anuh Pharma API processing plant

30-Mar-2016 - Anuh Pharma has breached GMP rules at its API processing facility in Boisar, India say French regulators who visited the site last month.

Svizera: Premature WHO suspension notice at Indian plant 'hugely damaging'

21-Mar-2016 - The WHO has withdrawn a notice stripping Svizera Labs of prequalification status that it published in error last week.

Tesco and Waitrose supplier Marksans banned from shipping non-critical meds to UK

21-Mar-2016 - The UK MHRA has accused Marksans Pharma of destroying manufacturing records and banned the Goa, India firm from supplying “non-critical” drugs.

Affymetrix rejects Origin offer and backs Thermo Fisher merger

21-Mar-2016 - Affymetrix has rejected a $1.5bn rival bid and said it prefers to merge with Thermo Fisher Scientific.

News in brief

US FDA raises concerns about Lupin's Goa plant

17-Mar-2016 - The US FDA has criticised operations at a Lupin manufacturing plant in Goa, India.

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