Regulatory Pharma Blogs
How Expiry Dates Are Determined for Medicines Expiry Dates When you look at the label of any medicine, you’ll notice an expiry date printed clearly on the package. This date is not chosen randomly; it is the outcome of years of research, strict regulatory guidelines, and scientific testing. The expiry date is essentially a guarantee …
Impact of Granule Particle Size on Dissolution of BCS Class II and IV Drugs Granule Particle Size: Drug development and formulation science often revolve around one central theme: how efficiently a drug dissolves in the body. Dissolution is a prerequisite for absorption, and therefore, bioavailability. For drugs classified under the Biopharmaceutics Classification System (BCS), particularly …
Static Charge in Pharmaceutical Blending: Origins, Consequences, and Control Strategies Static Charge in Pharmaceutical Blending When scientists and formulators think of blending active pharmaceutical ingredients (APIs) with excipients, the first thoughts are usually consistency, efficiency, and achieving a homogeneous mixture. Blending is, after all, the backbone of dosage form preparation. But hidden in the background …
Forced Degradation Studies for API Selection Forced Degradation Studies Selecting a suitable active pharmaceutical ingredient (API) is a critical step in drug development, and one of the most important aspects of this process is understanding how the API behaves under different conditions. Among the tools used by formulation scientists, forced degradation studies are indispensable. These …
Pharmaceutical Formulation Development Formulation development refers to the process of designing, refining, and producing drug formulations suitable for commercial use. The goal is to convert an active pharmaceutical ingredient (API) into a stable and effective dosage form that is safe for patients while ensuring therapeutic success. In the pharmaceutical industry, formulation development is a cornerstone …
Online f1 and f2 factor calculator in dissolution software free Online f1 and f2 factor: A biowaiver refers to the exemption from conducting in vivo bioequivalence or bioavailability studies. Instead of relying on expensive and time-consuming bioequivalence trials, dissolution profile comparison can serve as a substitute for determining whether two drug formulations are equivalent. This …
Computer System Validation in the Pharmaceutical Industry Computer System Validation (CSV) is a structured process applied to computerized systems used in regulated pharmaceutical environments. Its purpose is to confirm that a system consistently performs according to its intended design, meets predefined requirements, and ensures the safety, reliability, and integrity of electronic records. In essence, CSV …
Predictive Maintenance and Machine Learning in GMP Environments Predictive Maintenance (PdM) is a proactive approach that relies on continuous monitoring and analysis of operational data to determine when equipment requires servicing. When implemented effectively, PdM reduces maintenance costs, minimizes equipment failures, and enhances overall reliability. In GMP (Good Manufacturing Practice) facilities, maintenance plays a critical …