The US FDA has released draft guidelines to identify trading partners in the pharma supply chain in accordance with the Drug Supply Chain Security Act (DSCSA).
The US FDA has warned doctors not to use any liquid drugs made by PharmaTech LLC over renewed concerns they may be contaminated with the bacteria Burkholderia cepacia.
More drugs were recalled in the US in the three months to the end of June than in any period since Q4 2014 according to analysis by Stericycle ExpertSolutions.
French regulators says Chongquing Succeway Pharmaceutical Co Ltd should recall APIs made at its plant in Chongquing after inspectors found evidence of record manipulation and an undeclared manufacturing area.
The US FDA has called on Tubilux Pharma SPA to identify potential contamination sources at its eye medicine production plant in Italy in a warning letter this week.
UK patients face drug shortages unless Tory Government Ministers negotiate an orderly withdrawal from the EU – Brexit – that safeguards existing approvals and continued regulatory cooperation according to pharmaceutical industry groups.
Cell therapy firms will be able to authenticate the foetal bovie serum (FBS) they use through a testing programme launched by GE Healthcare and Oritain.
Three biosimilar products submitted to the EU for approval have suffered a setback after regulators found 35 GMP deficiencies at Biocon’s fill/finish facility in Bangalore, India.
Failure to establish system suitability testing for heparin and heparin-related drugs has landed Shandong Analysis and Test Center a US FDA warning letter.
Concerns about Pfizer’s fill/finish plant in McPherson, Kansas have prompted the US FDA to reject the firm’s biosimilar version of Amgen’s anaemia drug Epogen.
Qinhuangdao Zizhu omitted, deleted and manipulated manufacturing data at its active pharmaceutical ingredient plant in Hebei, China according to the US FDA.
Corning says it is on the brink of capturing an increased share of the $12bn glass quality and packaging markets through material advancements in the space.
Pfizer has recalled four injectables – including the already scarce heart surgery drug Sodium Bicarbonate - made at Hospira's facility in Rocky Mount, North Carolina after identifying a potential contamination risk.
The European Commission has confirmed that UK drug ingredient manufacturers will have to supply European customers with written confirmation their products are made in compliance with EU standards after Brexit.
Bristol Myers Squibb (B-MS) has recalled one lot of the oral anti-clotting drug Eliquis in the US after a customer found 2.5mg strength tablets in a bottle labelled as containing 5mg tablets.
3D printing, augmented reality and deep learning algorithms will shape the future of the pharmaceutical supply chain says Dr Bertalan Mesko, the Medical Futurist.
Drug industry concerns about natural disasters are driving demand for ‘storage-only’ stability testing according to Intertek, which has announced plans to expand its UK lab.
The US FDA has banned APIs made by Changzhou Jintan Qianyao Pharmaceutical Raw Materials after staff told inspectors their quality testing plans were “in their heads.”
Burkholderia cepacia contamination is a risk for drug makers according to the US FDA, which says only rigorous testing can ensure the safety of non-sterile, water-based products.
Nova DFL’s dental adrenaline product has been denied marketing authorisation after French regulators raised seven critical deficiencies at its facility in Brazil.
AB Science SA has halted French trials of its Ph III drug candidate masitinib after regulators uncovered good clinical practice (GCP) and pharmacovigilance deviations in an earlier study.
President Donald Trump should foster biotech investment if he wants more US-made pharmaceuticals say experts who argue that cutting regulations to attract small molecule drug manufacturers will only have a limited effect.
Italian regulators say Kores Limited’s facility in Roha, India should be banned from supplying the API ambroxol hydrochloride to the EU and advised users to find an alternative source.
Issues in the quality testing of drug substance and product were among eight observations cited in a Form 483 following an inspection at Biocon’s site last month.
The US FDA has accused Vikshara Trading & Investments Ltd. of giving false statements about a strike to delay the inspection of an Ahmedabad API plant later found to be non-compliant.
An inconsistent lot of excipient Poloxamer 188 cut biologic yield 30%, but working with supplier BASF was key to prevent future problems, according to Roche.
The US FDA has identified problems at Dr Reddy’s generic drug manufacturing site in Bachupally, India according to a filing on the Bombay Stock Exchange (BSE).
The UK MHRA saw an increase in sterility issues at drug plants in 2016 although quality system problems remained the most common deficiency seen during inspections.
The US FDA has warned Lonza about operations at its facility in Walkersville, Maryland, raising concerns about validation and aseptic process simulations.
Samsung Bioepis’ Renflexis has become the second biosimilar of rheumatoid arthritis biologic Remicade (infliximab) to be recommended for approval in the US.
Discovery of data problems at Qinhuangdao Zizhu’s Hebei API plant indicates the firm did not follow a remediation plan agreed after a prequalification inspection in 2015 according to the WHO.
Manufacturing tweaks have severe effects on the quality and yield of stem cells, says Pluristem which has successfully scaled-up production through a decade of process development evolution.