Tackling DSCSA Compliance in Saleable Items Returns
There is a palpable relief within pharmaceutical industry as the deadline for DSCSA’s requirements for saleable returns has extended by a year. The deadline has been extended till November 2020.
Natoli Engineering, a global leader in tablet tooling manufacturing, held a one-day tablet compression training in two locations (Indonesia and Thailand) in November 2019.
Pharmaceutical drugs remain one of the most thriving counterfeit markets in the world today. This has far reaching implications on the pharma industry as well as the wider society. There are no exact numbers on the scale of counterfeiting or its impact, but a recent PwC Strategy study provides a disturbing perspective on both the scale and far reaching implications of pharma counterfeiting
Exclusive interview with Mr. Kartik Gandhi, Director, Gandhi Automations Pvt Ltd.
Q. Going forward, what are the changes you see in the global pharmaceutical industry?
“The global pharmaceutical industries will continuously grow in developing biologic drugs. Global pharmaceutical companies will allocate more resources to develop innovative drugs, cutting-edge med-tech,
This article is contributed by Dr. Parag Shah, Sr General Manager – International Sales and Business Development, Kevin Process Technologies. The pharmaceutical formulations manufacturing is beginning to concentrate on continuous manufacturing and granulation is one of the key processes that requires to be continuous. Not only does continuous granulation allow for lower costs, but also very efficient and effective manufacturing operations,
In a running plant, modification and up-gradation comes with challenges like:
a) Multiple automation platforms b) Ensure proper validation documentation. c) In-line up-gradation and production plan together. d) Unavailability of program backup
It is common for tablet manufacturers to exceed the maximum compression force ratings of their tooling to form a quality tablet. This situation usually arises when an issue with the formulation or powder causes the press operator to exceed the recommended force range of the tooling in an attempt to produce an acceptable product. However, going beyond the prescribed tooling rating may result in premature tool wear or failure and possible damage to the press.
Has production ever been halted due to dark spots on your tablets? If you answered yes, you’re not alone. Dark spots are a common defect that arise during the tablet manufacturing process and determining their primary cause can be difficult. In this article, we’ll discuss how to determine if the dark spots in your tablets are a result of one of these common causes:
Data Integrity – these two words, in the recent past, have impacted companies, personnel and investors – damaging the perception of ‘Brand India’. Having pursued my career as a quality professional for over 3 decades and having closely tracked the regulatory space, I would like to present my views on this challenge that ‘Brand India’ is facing, and the steep learning curve that India based firms are going through, as they seek to overcome this challenge.