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UK medical cannabis manufacturer granted GMP registration
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a UK manufacturing facility good manufacturing practice (GMP) registration for its cannabis API.
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Good Manufacturing Practice (GMP)
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorisation and licensing for manufacture and sale of drug products and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
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Switzerland and US sign drug inspection agreement
To promote Good Manufacturing Practice, Switzerland and the US have signed a Mutual Recognition Agreement to improve pharmaceutical drug inspection.
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Case study: Expedite microbial contamination investigations
Find out how rapid microbial monitoring can help mitigate lengthy contamination investigations by identifying the root cause of high plate counts.
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Whitepaper: Imaweld® heat sealable & weldable tube bioprocess media
Imaweld® is distinct due to its composition, which seals and welds tubes and highly endorsed in biopharma for cell membrane and cell culture applications
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Implementing a real-time PCR-based method for sterility release testing of ATMPs
23 December 2022 | By Sartorius
Dr Alexandra Mueller-Scholz, Sartorius, and Yasmin Heynen, Molecular Development at Labor LS, discuss rapid sterility testing for ATMPs using a real-time PCR-based method.
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Whitepaper: Optimising the efficiency of QC laboratory: The power of automation
Charles River launches Endosafe Nexus 200, emphasises the importance of automated endotoxin testing systems to improve the efficiency of QC labs.
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Whole genome sequencing and analysis of live biotherapeutic products
Here, Snehit Satish Mhatre and Michael Timm of Eurofins discuss considerations and recommendations for the testing of live biotherapeutic products.
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Whitepaper: Single-use technologies in biosimilar development
ImaLINK™ manifold, which is designed to minimise the need for fittings, connections or assembly of all leak points, entrapment areas are eliminated.
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The lingering menace of diethylene glycol / ethylene glycol adulteration
Although it was first identified in the 1930s, diethylene and ethylene glycol contamination remains an issue today, as Dave Elder explains.
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European Pharmaceutical Review Issue 6 2022
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...
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Catalent opens one of largest cell therapy manufacturing facilities in the world
Sited in Belgium, Catalent has opened one of the largest commercial-scale cell therapy manufacturing facilities in the world.
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CPI opens £88 million manufacturing innovation centre
CPI has opened its Medicines Manufacturing Innovation Centre in Scotland to focus on efficient, sustainable manufacturing and advance medicine research.
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EMA launches quality control group to aid medicine innovation
A new regulatory group, part of the European Medicines Agency, will aid innovative approaches for the development and quality control of medicines, including new technologies for EU patients.
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Using UHPLC-MS/MS for trace detection of β-lactam antibiotics
Researchers demonstrate ultra high performance liquid chromatography with triple quadrupole mass spectrometry to detect and quantify trace amounts of cephapirin and ceftiofur.
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Innovation in pharma manufacturing quality systems
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.
