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Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorisation and licensing for manufacture and sale of drug products and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
With the appropriate formulation strategies, the challenges around poorly soluble compounds can indeed be overcome. Reducing development time and ultimately speeding up the route to market.
This whitepaper considers the latest EU GMP Annex 1 draft and its impact on the control and release of sterile products.
Disinfectants must be qualified on the surfaces in a pharmacopeial manufacturing environment prior to use in the facility. Building a study with robust parameters and avoiding common pitfalls is critical to avoid negative responses from regulatory agencies.
In the wake of the UK’s agreed deal with the EU, Andrew Howard, Deputy Director for Trade, Regulation and Analysis in the Office for Life Sciences, offers advice to those life sciences businesses navigating the transition to a new regulatory landscape.
Product characterisation facilitates easier process design to ensure the biological drug attains critical product safety, purity, and potency.
iCON has improved delivery capacity by standardising the infrastructure for a flexible and readily available drug manufacturing facility.
iCON has improved delivery capacity by standardising the infrastructure for a flexible and readily available drug manufacturing facility.
This on-demand webinar will provide aspects of a sterility assurance program for a pharmaceutical product. Sterility assurance begins at the early stages of product development and follows through the entire product lifecycle.
Readily deployable, fully integrated mobile testing labs for fast-track delivery of diagnostic and analytical lab capability where and when needed.
The use of flexible mobile biocontainment and test units to prevent the spread of transmissible diseases.
Learn how Process Analytical Technology (PAT) and real-time TOC testing of pharmaceutical grade water systems can improve efficiency.
Medicines and other healthcare products rely for their value, integrity and commercial longevity on a delicate balance between quality, safety and efficacy.
G-CON’s standard POD maximises efficiencies in production, qualification and cost and eliminates the complexity of cleanroom construction projects.
![Male Thai child receiving oral polio vaccine from healthcare worker [Credit: frank60 / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Oral-vaccine-300x278.jpg)
![Male Thai child receiving oral polio vaccine from healthcare worker [Credit: frank60 / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Oral-vaccine.jpg)
The market is expected to grow at a 6.7 percent CAGR, driven by the increasing prevalence of cancer and cardiovascular diseases, as well as growing interest in biologics.
In this ebook, discover innovative solutions for three core areas of drug development: drug formulation, scale-up and analysis with hot melt extrusion; quality control and validation using microscopic and spectroscopic instruments; and instrumentation for nucleic acid quantification and qualification.
