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This article provides an overview of the key risks that can be associated with the use of secondary reference standards (RS) and illustrates scientific challenges associated with transitioning from pharmacopeial RS to secondary RS.
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The authors consider several common techniques for verifying the accuracy of liquid-handling equipment and offer guidance for finding the appropriate technique for a given instrument.
Guest contributor Frederic Kahn discusses the state of the Indian pharmaceutical manufacturing industry.
Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.
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The authors describe the background and applications of fully formulated aqueous shellac for film-coating systems.
The SD File format offers benefits for KASA and cheminformatics to support regulatory submissions.
Change of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.
This tutorial paper is meant to aid in dielectric-sensor selection
Hayley Crowe, Executive VP & GM at Ecolab Global Life Sciences, talks about the company's services and how they relate to trends in bioprocessing and purification.
IREM can be used for effectively assessing and mitigating risks and improving the overall sterility assurance level in all types of aseptic processing lines.
The recent amendment to Annex 1 has seen controversial changes relating to the capping of vials.
Testing the dissolution rates of a pharmaceutical formulation (also known as in vitro availability) aids drug quality control and is a compulsory requirement of the British, European and US pharmacopoeias.
Automated systems help detect and resolve quality issues.
This paper reflects upon the past 15 years of experience in the application of QRM and KM within the pharmaceutical GMP environment.
A well-chosen replication strategy can effectively reduce the uncertainty for an analytical method, enabling appropriate decisions regarding pharmaceutical quality.
The complete online database of ACS Reagent Chemicals is now available.
Using new co-processing technologies, the authors show that it is possible to formulate an 'all-round' excipient.
Innovation is driven through a strong digital backbone.
The rising popularity of fast dissolving, immediate-release dosage forms can be attributed to their convenience and ease of administration.
By eliminating the waste involved in traditional approaches to project set-up and execution, integrated project delivery helps innovators in the European life sciences market meet their fast-track delivery targets.
The authors describe the background and applications of fully formulated aqueous shellac for film-coating systems.
Contract service providers offer vital services to bio/pharma companies of all sizes. Establishing an effective working relationship and managing operations are key to avoiding compliance issues.
The authors describe the factors affecting reconstitution time of dry powder for injection and classifies them as intrinsic and extrinsic parameters.