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Case study: MMTS Mini tabs child-friendly dosing
MMTS Mini tabs delivers child-friendly, broad-range dosing for toddlers.
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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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News: Endotoxin automation is achieved with microfluidics for simple, compliant BET
Automated endotoxin testing is achieved in a compact platform, leveraging microfluidic liquid handling. QC labs simplify BET with easier, compliant assays using less LAL.
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Case study: New trends: reducing GWP impact on GMP freeze drying processes
How to turn an older refrigeration system in an existing freeze-dryer into a new environmentally friendly cooling system.
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Whitepaper: Analytical testing considerations for ATMPs
This whitepaper discusses the analytical testing considerations for complex biological materials in ATMPs.
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Case study: Microcaps exceeds stringent requirements
Microcaps exceeds stringent requirements beyond taste masking.
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Recombinant bacterial endotoxin testing techniques shown to be inferior
An evaluation comparing Limulus amebocyte lysate to recombinant alternative assays has found that the recombinant reagents had markedly low recovery of endotoxin activity.
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Further woes for Emergent’s Bayview vaccine production facility
An FDA inspection identified nine concerns including unsanitary conditions and ineffective practices for preventing cross-contamination at Emergent’s facility.
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Balancing regulations for weighing in a GMP quality control laboratory
The importance of analytical balances in laboratory operations demands that they be fit for purpose over the operating range and acceptance criteria specified in the laboratory user requirements specification. In this article, Bob McDowall, Director of R D McDowall Limited, discusses the regulatory requirements for analytical balances operating in GMP…
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Case study: Finding impurities and controlling formations at release
Case study example regarding finding impurities and controlling formations at release.
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FDA halts COVID-19 vaccine production at Emergent facility
The FDA has requested Emergent’s Bayview plant be closed and vaccine production halted while the agency investigates potential good manufacturing practice (GMP) violations.
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Your endotoxin experts
ACCI has been a global leader in endotoxin and (1→3)-ß-D-glucans detection products and services for more than 45 years and has grown to be an internationally recognised leader in endotoxin detection. Find out why they should be your choice in of endotoxin experts in this guide.
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On-demand webinar: Optimising MALDI-TOF for filamentous fungi ID
Challenges and solutions to adopting MALDI technology for filamentous fungi ID with emphasis on sample preparation and database development.
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Quality Risk Management tools to improve data integrity in micro QC
12 April 2021 | By Charles River Laboratories
Watch this on-demand webinar with Jordi Iglesias to learn how you can improve the data integrity of your microbiological QC assays.
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Whitepaper: Continuous wet granulation and fluid-bed drying
Continuous wet granulation and drying have long been a hot topic in pharmaceutical manufacturing. The QbCon® 1 system solves all existing problems.
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Brochure: Integrated bioprocessing
The journey from large molecule to approved biotherapeutic is long, costly, complex, and fraught with risk – yet rewards for success are substantial.
