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From Our Blog
What is Process Validation?
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...
What You Need To Know About Equipment Qualification
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...
What Is The Benefit Of Doing An Engineering Batch In The Pharmaceutical Industry?
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...