Related Experiment Video

Updated: Apr 28, 2026

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

4.3K

Current good manufacturing practices, quality control procedures, quality factors, notification requirements, and

    Federal Register
    |June 14, 2014
    PubMed

    More Related Videos

    Individualized Reconstitution of Human Milk Microbiota: A Feasible Approach in Real-World Settings04:16

    Individualized Reconstitution of Human Milk Microbiota: A Feasible Approach in Real-World Settings

    Published on: February 7, 2025

    1.0K
    A cGMP-applicable Expansion Method for Aggregates of Human Neural Stem and Progenitor Cells Derived From Pluripotent Stem Cells or Fetal Brain Tissue09:37

    A cGMP-applicable Expansion Method for Aggregates of Human Neural Stem and Progenitor Cells Derived From Pluripotent Stem Cells or Fetal Brain Tissue

    Published on: June 15, 2014

    12.2K

    Related Concept Videos

    FDA Approved Drugs: Changes to Approved Drugs01:26

    FDA Approved Drugs: Changes to Approved Drugs

    Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
    341
    Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

    Clinically Relevant Drug Product Specifications: Methods of Establishment

    Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
    300
    Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

    Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules

    Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
    418
    Drug Regulation01:25

    Drug Regulation

    Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
    3.0K
    Drug Dosing: Infants and Children01:29

    Drug Dosing: Infants and Children

    Pediatric patient dosages diverge from adults due to disparities in body surface area, total body water, and extracellular fluid per kilogram of body weight. The dosing regimen considers the variations in pharmacokinetics and pharmacology across distinct age groups, encompassing preterm newborns, infants, young children, older children, and adolescents. Calculation of pediatric patient doses is predicated on determining body surface area, which exhibits a superior correlation with the child's...
    1.0K
    Production of Pharmaceuticals01:30

    Production of Pharmaceuticals

    Industrial insulin production uses genetically engineered E. coli expressing a proinsulin gene controlled by a tryptophan promoter and containing a methionine linker for later cleavage. The cells also carry ampicillin resistance for selective growth. Seed cultures are stored at −80 °C and production begins by thawing a small amount to inoculate starter cultures, which are progressively scaled to a 50,000-L bioreactor. In the bioreactor, E. coli grow in nutrient-rich media under...
    90