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Differences Between eCTD and ACTD Dossier
eCTD (Electronic Common Technical Document) ACTD (ASEAN Common Technical Dossier) Key Differences Read also: Resource Person: KABYA PRATAP ROYAL
Difference Between OOS and Deviation
OOS (Out of Specification) and deviation are terms commonly used in the context of quality management, particularly in pharmaceuticals industries. Here’s a brief overview of each term: Out of Specification (OOS) Definition: An OOS result occurs when the test results of a sample fall outside the established acceptance criteria or ... Read More
Difference Between CBER and CDER
๐๐๐๐ฅ (๐๐ฒ๐ป๐๐ฒ๐ฟ ๐ณ๐ผ๐ฟ ๐๐ถ๐ผ๐น๐ผ๐ด๐ถ๐ฐ๐ ๐๐๐ฎ๐น๐๐ฎ๐๐ถ๐ผ๐ป ๐ฎ๐ป๐ฑ ๐ฅ๐ฒ๐๐ฒ๐ฎ๐ฟ๐ฐ๐ต) ๐ฅ๐ฒ๐ด๐๐น๐ฎ๐๐ผ๐ฟ๐ ๐๐๐๐ต๐ผ๐ฟ๐ถ๐๐: CBER regulates biological products, which are complex substances derived from living organisms or their byproducts. These products include vaccines, blood products, gene therapies, tissues, and medical devices that contain biological components. ๐ฅ๐ฒ๐๐ถ๐ฒ๐ ๐ฃ๐ฟ๐ผ๐ฐ๐ฒ๐๐: CBER reviews applications for Biologics License Applications (BLAs) ... Read More
Difference Between ICH and USFDA Guidelines
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, ... Read More
Difference Between 21 CFR Part 11 and EU GMP Annex 11
Navigating the complex waters of Life Sciences regulations? Two standards tower above the rest – 21 CFR Part 11 and EU GMP Annex 11. Hereโs why theyโre non-negotiable: Foundation of quality and integrity: Both safeguards ensure the highest standards of Quality, product integrity, and safety in the Life Sciences. Compliance ... Read More
Difference Between Extractables and Leachables
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 ... Read More
Difference Between QbD and DoE
Quality by Design (QbD) vs Design of Experiments (DoE) (concepts comparison) Definition: Focus: Application: Approach: Read also: Resource Person: Atefe Nasrollahi
Difference Between Quality Control (QC) and Quality Assurance (QA)
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 ... Read More
Difference Between Calibration and Qualification
A list of differences between calibration and qualification are mentioned below: Similarities Read also:
Difference Between Out of Specification (OOS) and Out of Trend (OOT)
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 ... Read More