news
BioPure Q-Clamp is compatible with a wide range of connector geometries
The latest innovation from Watson-Marlow Fluid Technology Group brand BioPure is the Q‑Clamp, a new sanitary Tri-Clamp® for single-use fluid path applications...
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QA/QC
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KENX announces Computer Systems Validation and Data Integrity Compliance Congress set for Dublin, Ireland
The CSV and Data Integrity Compliance Congress offers customisable, top-notch training for FDA compliance challenges.
news
Quality control method to select effective MβCD in Neimann-Pick disease
Researchers have developed a quality control method to evaluate the pharmacological activity and potential effectiveness of different preparations of the therapeutic agent MβCD...
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Paul G Royall
12 September 2017 | By
Senior Lecturer in Pharmaceutics at King's College London
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...
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…
article
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...
article
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...
