According to WHO, Technology transfer (TT) is defined as “The transfer of the manufacturing process for a new pharmaceutical Drug Substance (DS) and Drug Product (DP), respectively, from the transferring site (in this case R&D) to the receiving site or designated commercial manufacturing site. Major Steps of Technology Transfer Activities 1. Identification of technology…
Health-Based Exposure Limits (HBELs) in cleaning validation refer to the maximum allowable amount of residual drug substance or cleaning agent that can be present on a surface after cleaning without posing a risk to patient safety. These limits are established based on toxicological data and are used to ensure that the residues left behind…
Become an expert in cleaning validation with these 20 important tips for dealing with microorganisms: 1. Develop a cleaning validation plan that includes microbiological testing. 2. Identify the critical areas and equipment that require cleaning validation. 3. Establish acceptance criteria for microbiological cleanliness . 4. Use appropriate sampling techniques to collect samples for testing. 5….
Today, we are going to share an important lesson from the world of generic pharmaceuticals – the journey of an ANDA (Abbreviated New Drug Application) and what happens when a company encounters a Refuse-to-Receive (RTR) letter from the FDA. The RTR letter serves as a vital communication tool, highlighting specific issues that need attention…
If you are a manufacturer or a processor of FDA-regulated products, sooner or later, you can expect a visit from FDA. The purpose of this visit is to verify compliance with all relevant regulations — most commonly referred to as an “FDA inspection.” But not all inspections are created equal. FDA Inspections The four…
This certification allows generic drug companies to challenge brand-name drug patents before expiration, seeking approval to market their generic version early. They declare the patent invalid, unenforceable, or not infringed. The brand-name manufacturer is notified and can initiate a patent infringement lawsuit within 45 days. If the court rules in favor of the generic company,…
In ANDA submissions, the FDA typically requires stability data for at least 180 days. This data is a part of the chemistry, manufacturing, and controls (CMC) section of the application. The purpose of stability studies is to demonstrate the drug product’s stability over time, ensuring its quality and efficacy throughout its shelf life. This…
1. Accelerated stability studies These studies involve subjecting the pharmaceutical product to higher temperatures and humidity levels than normal storage conditions to determine its stability over a shorter period of time. 2. Long-term stability studies These studies involve storing the pharmaceutical product under normal storage conditions for an extended period of time, typically up…
