What Is Good Laboratory Practice (GLP)?
In the pharmaceutical industry, ensuring the safety, quality, and reliability of laboratory data is critical before any drug reaches the market. Good Laboratory Practice (GLP) is a globally recognized quality system that governs how non-clinical laboratory studies are planned, performed, monitored, recorded, and reported.
What is the Global Substance Registration System (GSRS)?
In the modern pharmaceutical landscape, where global harmonization and data accuracy are critical, the Global Substance Registration System (GSRS) has emerged as a powerful solution for substance identification and standardization.
What is a Product Information File (PIF)?
The pharmaceutical industry is highly controlled and in this regard, it is important to maintain the safety, quality and compliance of the products. The Product Information File (PIF) is a key component of attaining these objectives.
Introduction to Post Approval Change
Post Approval Change (PAC) is defined as “any change to a product, process, or documents after approval by the relevant authorities.” The need for PAC is generally high in industries such as pharmaceuticals, biotechnology, and medical devices, where compliance is the key, even after the product is launched in the market.
Introduction to Regulatory Variations
Regulatory variations refer to differences in laws, rules, standards, and compliance requirements in different countries, regions, or industries. This affects how different companies operate, especially those expanding and growing globally.