Process validation too slow? Here’s how to speed things up
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.
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.
Technology transfer aims to commercialize products successfully at your contract manufacturing organization (CMO) partner site. This means the manufacturing, analytics, packaging, relevant.
A pharmaceutical technology transfer or more commonly known as a tech transfer, is a series of knowledge transfers on a drug product and its established manufacturing processes from development to.
A feasibility study is a trial run that tests your manufacturing steps, materials, and equipment to confirm that your process is designed correctly. During a feasibility study, any differences in the.
To submit a filing to the FDA, whether that be an NDA, ANDA, or 505(b)(2), a product owner must provide technical files containing a pharmaceutical product's chemistry, manufacturing, and control.
