Process validation too slow? Here’s how to speed things up
COVID-19’s impact on global supply chains as well as tectonic geopolitical shifts have resulted in considerable disruption, particularly to the contract development and manufacturing organization.
As part of Bora Pharmaceuticals’ global growth strategy, the company successfully completed the acquisition of GSK's Mississauga, Ontario (Canada) facility in 2020. Representing Bora’s first.
There are many benefits to using a pharmaceutical contract manufacturer (CMO). Many small to mid-sized pharmaceutical companies utilize them for developing their drugs when they don’t have their own.
In pharmaceutical contract manufacturing, outsourcing your product to the right Contract Development and Manufacturing Organization (CDMO) can be a daunting and concerning task. After conducting the.
In part two of these blog posts authored by Dr. David Barnes and Lonnie Barish, we will discuss the various types of topical products (ointments, creams, gels, sprays, and lotions), detailing their.
There has been increased interest in the development of topical drug products as a way to deliver drugs locally, rather than systemically and for diseases that occur in the skin, mucosal surfaces,.
The Process Validation (PV) Guidance from the FDA (January 2011) adopts the product lifecycle concept, emphasizing the expectation that process validation starts with process design and carries.
Equipment qualification is critical in the pharmaceutical industry. The equipment not only includes manufacturing equipment but testing and sampling equipment also to name a few. Even the slightest.
So, your new product is ready for the next step – commercial manufacturing production. You have decided not to invest in new equipment or building a new manufacturing line. You’re now looking to.
