ICH and USFDA guidelines are two of the most important sets of regulations for the pharmaceutical industry. Both sets of guidelines aim to ensure the safety, efficacy, and quality of pharmaceutical products. However, there are some key differences between the two sets of guidelines in terms of their scope, jurisdiction, development process, and applicability. ICH…
Navigating the complex waters of Life Sciences regulations? Two standards tower above the rest – 21 CFR Part 11 and EU GMP Annex 11. Here’s why they’re non-negotiable: Foundation of quality and integrity: Both safeguards ensure the highest standards of Quality, product integrity, and safety in the Life Sciences. Compliance isn’t just about checking legal…
In the intricate world of biopharmaceutical manufacturing, the presence of extractables and leachables poses a significant challenge, potentially tarnishing the purity of invaluable drug products. The FDA offers precise definitions for these two critical terms: Extractables These are compounds that can be meticulously drawn out from the container closure system when a solvent enters the…
Quality by Design (QbD) vs Design of Experiments (DoE) (concepts comparison) Definition: Focus: Application: Approach: Read also: Resource Person: Atefe Nasrollahi
Quality control and quality assurance are two essential concepts that help ensure the safety and quality of the finished products. While both concepts share the same goal of maintaining high standards, they approach this goal in different ways. Quality control involves inspecting and testing products at various stages of production to ensure that they meet…
A list of differences between calibration and qualification are mentioned below: Similarities Read also:
OOS and OOT are two common terms in pharmaceutical quality control laboratory. In this article we mention the similarities and differences between Out of Specifications (OOS) and Out of Trend (OOT) Similarities between Out of Specifications (OOS) and Out of Trend (OOT) a. Both OOS and OOT are conducted in the pharmaceutical industry to identify…
GMP and cGMP are two common terms in pharmaceutical manufacturing. In this article we try to find out the differences between GMP and cGMP in pharma industry. “c” in cGMP “c” in cGMP stands for current, requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and…
Definition Computer system validation (CSV) is the process of ensuring that a computer system meets its intended use and performs as expected, while computer system/software assurance (CSA) is the process of ensuring that a computer system is secure, reliable, and available. Purpose The purpose of CSV is to ensure that a computer system meets regulatory…