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Issue 4 2017

 

Compressed gases: an important component of an environmental monitoring programme

25 August 2017 | By , ,

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…

Extractables – leachables correlations for packaging

22 August 2017 | By

Plastic materials, widely used in pharmaceutical packaging systems, can interact with the packaged product by transferring leachables. Leaching is important, as foreign leachable impurities can adversely affect the quality, efficacy and safe use of the packaged product, due to their chemical or physical nature, reactivity, and/or toxicity.

Quality control of freeze-dried oral formulations; challenges when developing novel approaches for the delivery of poorly-soluble drugs

22 August 2017 | By ,

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…

Continuous manufacturing: regulatory and quality assurance challenges

22 August 2017 | By , ,

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…

Developing OTC syrup packaging for the highly regulated EU market

21 August 2017 | By

The regulatory environment has a great impact on business, especially in healthcare. Non-compliance exposes companies to the risk of launch delay, delisting products from the market and out-of-stocks. Moreover, it can cause reputational damage affecting staff, consumer and shareholder confidence, reduce market opportunities, and affect the bottom line.

Outsourcing FM to drive excellence in premises and equipment management

21 August 2017 | By

When reviewing the range of activities required to deliver pharmaceutical products of the required high quality within a strict regulatory framework, an organisation will identify services, which while still business critical, are considered as non-core to the mission of the organisation. These non-core services still need to be delivered, either…

The importance of being small: miniaturisation of freeze drying equipment

18 August 2017 | By ,

Developmental activities for freeze-dried products are dictated by the limited availability and high cost of newly developed active compounds, and by Quality-by-Design requirements. Laboratory-scale freeze dryers used for formulation and process development show an excessive variety of designs and instrumentation concepts, making scale-up activities a challenge. The development of miniaturised…

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