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In its recent responses to FAQs relating to Annex 1, the European Medicines Agency (EMA) discusses bioburden guidelines for good manufacturing practice (CGMP) and good distribution practice (GDP).
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The European Medicines Agency (EMA) has made recommendations for industry on how to prevent medicine shortages and reduce their impact.
Although it was first identified in the 1930s, diethylene and ethylene glycol contamination remains an issue today, as Dave Elder explains.
This issue includes articles on Raman mapping of pharmaceutical tablets, delivery options for mRNA therapeutics, the use of high-throughput analytics for clonal cell selection and much more...
Over the last 10 years, there has been an important change of focus in pharma towards biotech products and personalised therapies. These important new treatments are now emerging into manufacturing, with implications for the way that quality is monitored, managed and assured. Dr Eduard Cayón sets out some practical advice.
1 March 2022 | By
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The Gates Biomanufacturing Facility announced a strategic agreement with Nkarta to manufacture Nkarta's investigational cell therapy NKX101.
Glenn Abood, founder and CEO of rfxcel, explains how real-time environmental monitoring can combat supply chain shortcomings, providing companies with level of data integrity, traceability, transparency and security that is virtually beyond reproach.
Dr Ash Ramzan, founder and principal consultant at Woodley BioReg, discusses how the COVID-19 pandemic has forced regulatory processes to adapt, focusing on the regulatory flexibilities introduced by the UK’s MHRA.
Jasper Ojela, a registered pharmacist who admitted to supplying the black market with drugs including cancer medications, has been given a 28-month prison sentence.
On 23 June 2016, the decision was made on the European Union referendum for the United Kingdom to withdraw from the European Union.
The ABPI has responded to a joint letter from Jeremy Hunt, Secretary of State for Health, and Greg Clark, Secretary of State for Business, published by the Financial Times, that outlined the UK Government’s plans for the regulation of medicines as the UK leaves the European Union (EU).
The FDA has approved the cryopreserved formulation of ReNeuron’s human retinal progenitor cell (hRPC) therapeutic candidate...
The EMA has approved Janssen's continuous manufacturing (CM) with real-time release testing for the production of Prezista (darunavir)...
