The use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefits in terms of effectiveness, minimal surface residue, and easier cleaning validation.
Using its Supplier Relationship Excellence (SRE) program, Amgen opened the lines of communication with suppliers and created a feedback loop where data can be shared to better understand operational performance.
Process validation establishes the elasticity and restrictions in manufacturing process controls to deliver upon the specified attributes of the dosage form while preventing undesirable results.
This article provides an overview of the regulatory guidelines and the fundamental GMP requirements with regards sterile manufacturing of medicinal products, with a particular focus on engineering aspects.
The global pharmaceutical market is worth US$300 billion a year according to the World Health Organisation (WHO), and this figure is expected to rise to US$400 billion within three years.
How transfer systems like pneumatic conveyors enable processors to boost process efficiency and reduce contamination.
Validation of container integrity must demonstrate no penetration of microbial contamination or gain or loss of any chemical or physical parameter deemed necessary to protect the product.
Continued Process Verification (CPV), Process Analytical Technology (PAT) and Quality by Design (QbD), are driving pharma to improve product and process quality and efficiency.
Despite their potential to increase the efficiency healthcare, autologous cell therapy treatments present significant challenges to most companies when it comes to development and manufacturing.
In the rush to market, be aware of these critical missteps that can occur during the early development phases, in order to avoid major challenges later during commercial API scale-up.
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