Spectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing.
Storage and retrieval methods and the unique requirements found in building codes are crucial considerations.
Getting to the root of the cause can prevent future problems, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
Using a QbD approach in the development and formulation of topical products will enable the drug developer to provide a robust control strategy for manufacturing.
Policies emphasize the importance of ensuring data integrity in the United States and abroad.
The Flexicon FPC60 peristaltic fill/finish system from Watson-Marlow Fluid Technology Group can use a variety of modules that allow users to create their own customized filling solution to suit small-batch applications.
The Pharmafill PS1 Packserter desiccant inserter from Deitz Company features a proprietary cut length sensor system that automatically verifies the desiccant, oxygen absorber, or other packet has been properly fed from the continuous strip before allowing it to be cut for inserting.
The Ross VersaMix is a multi-shaft mixer suited for viscous applications requiring a high level of accuracy and batch-to-batch consistency.
Kimberly-Clark Professional’s Kimtech A5 Sterile Boot Covers with Clean-Don Ties and Vinyl Edge provide reliable sterile protection for ISO Class 5 or higher cleanrooms.
Recent advancements in cold-chain technology offer improved transporting and storing of temperature-sensitive pharmaceutical products.
New platform technologies, advanced modeling tools, and addressing patient needs are important developments.
Robotic isolators and single-use technologies are gaining ground, according to aseptic processing consultant Jim Agalloco.
The challenge of achieving sustained delivery of an active ingredient or nutrient can be achieved with extended-release formulations.
Leveraging vast quantities of analytical data requires digitalization and platform integration.
Technical advances in process understanding and control must be accompanied by a change in mindset.
When transferring a method from R&D to quality control, success hinges on discovering where “the best” and “the most reliable” intersect.
Biosimilars, pricing strategies, and technology will influence growth in spending on drugs.
The market for biosimilars in Europe remains consistently robust, with 16 new biosimilars approved in 2018.
Political instability is causing uncertainty in Europe and wreaking havoc with US regulatory timeframes.
Various groups and stakeholders from pharma, healthcare, and government are responding to a new draft environmental risk assessment guidance from EMA.
A new initiative has been launched to help stimulate industry discussion on innovative tech for use across the drug supply chain.
Click the title above to open the Pharmaceutical Technology February 2019 issue in an interactive PDF format.
