Process validation too slow? Here’s how to speed things up
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.
GxP is a general term used to describe the quality guidelines and regulations applied in the pharmaceutical industry. GxP is the abbreviation of “Good x Practice”. The “x” in GxP stands for the field.
Although regulations often vary by region, regulators intend to protect public health. Regulatory authorities are expected to carry out their public health mandates by facilitating the timely.
We are often asked, “Why do we need Pharmaceutical Feasibility Studies?”. In the development of a new drug, it is important to note that a feasibility study is probably the single most important.
