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 eye, and/or wounds of these surfaces. There are reduced side effects and toxicity to other organs compared to systemic delivery. Topical drug products are typically formulated to enable 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 throughout the entire lifecycle of a commercial product. During the process qualification stage, the process design is evaluated to determine if the process is capable of consistently delivering quality...
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 error or misuse can pose a costly risk and time delay for the pharmaceutical product owner and their manufacturer. So, what is equipment qualification? It is a series of inspections, tests, and...
Not going to invest in your own new equipment or building a new manufacturing line? Engineering trials and CMOs are here to help! 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 partner up with a contract manufacturing organization (CMO) for your...