news
Methodology developed for assessing the value of new medicines
The Advance Value Framework has addressed the pitfalls of current approaches assessing the value of new medicines...
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QA/QC
article
Compressed gases: an important component of an environmental monitoring programme
The quality attributes of manufactured pharmaceutical products include the physical, chemical, and microbiological characteristics of the raw materials, excipients and active pharmaceutical ingredient (API), as well as the final drug product (see Table 1). Absence of microbiological contamination is considered a critical quality attribute due to its potential to dramatically…
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QA/QC In-Depth Focus
In this In-Depth Focus: Quality control of freeze-dried oral formulations; Regulatory and quality assurance challenges in continuous manufacturing...
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Environmental Monitoring In-Depth Focus 2017
In this in-depth focus: Compressed gases - an important component of an environmental monitoring programme; The people factor - contamination of cleanrooms caused by personnel...
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Quality control of freeze-dried oral formulations; challenges when developing novel approaches for the delivery of poorly-soluble drugs
A common obstacle encountered in the early stages of drug development is the formulation of poorly water-soluble drugs (PWSDs). One effective approach to improve the dissolution of PWSDs is to render such drugs into their amorphous or disordered form. However, amorphous materials are both physically and chemically unstable, and tend…
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Continuous manufacturing: regulatory and quality assurance challenges
During 2002, the United States Food and Drug Administration (FDA) requested rationalisation and modernisation of the manufacturing base for pharmaceutical production. This was in the hope that modernising the supply chain would enhance the robustness of manufacturing processes, thereby reducing product failures and, importantly, significantly enhancing product quality.1 The FDA’s…
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Current trends in freeze-drying
This article reviews the trends in freeze drying highlighted at recent Parenteral Drug Association (PDA) conferences...
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Extractables and leachables – safety-based limits
A thorough understanding and control of extractables and leachables in liquid and semi-solid products has long been a regulatory requirement.1,2 Regulatory guidelines require that product contact surfaces are “not reactive, additive or absorptive”.3
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Issue #4 2017 – Digital Version
In this issue: Miniaturisation of freeze drying equipment, driving excellence in premises and equipment management, a guide to ingredients, and much more...
news
Accelerated drugs approval evaluated
Researchers have evaluate the features of pre-approval and post-approval clinical trials of drugs granted Accelerated Approval by the FDA...
news
New library to help organisations implement ISO 9001
ISO 9001 is a standard that sets out the requirements for a Quality Management System, its aim is to help businesses and organisations be more efficient...
product
Product hub: Introducing PerkinElmer’s LAMBDA 365 UV/Vis System
An industry-leading, compact, versatile and easy-to-use double-beam spectrophotometer that helps you ensure compliance with CFR 21 Part 11 regulations...
news
Viavi MicroNIR™ Tablet Probe unlocks accelerated analysis of pharmaceutical tablets & pills, food manufacturing and seed quality
Novel optical technology ensures repeatable sample analysis results...
news
Tecan launches new range of clear disposable tips
Tecan has introduced a selection of clear Liquid Handling (LiHa) disposable tips*, creating a one-stop shop for all your disposable tip needs...
news
AdvantaPure® announces its ISO 9001:2015 Certification
Validates the Company’s Quality Management System...
