Pharma Blog
Benefits of Pharma 4.0
Pharmaceutical manufacturers face many unique challenges in this remarkable era. While technological advancements have multiplied opportunities for process improvements, regulatory oversight has allowed adoption compared to other industries. There are stringent requirements for documentation, process validation, and data integrity to create an environment where compliance outweighs continuous improvement. Pharma 4.0 ... Read More
Top Trends of Pharma 4.0
Faster production The pharmaceutical industry is shifting from producing drugs for the masses to high-value treatments. Manufacturing life savingdrugs in low volumes complicates the manufacturing process as the latter is just as rigorous and time-consuming as the mass production workflows. Low volume production faces challenges because there are fewer batches ... Read More
Dietary Reference Intakes for Vitamin C (Ascorbic Acid)
Primary function: Antioxidant; enzyme cofactor for carnitine, collagen, neurotransmitter biosynthesis; modulates absorption, transport, storage of iron. Selected sources: Citrus fruits, sweet peppers, kiwifruit, broccoli, strawberries, brussels sprouts, cantaloupe. Dietary Reference Intake Vitamin C functions physiologically as a water-soluble antioxidant by virtue of its high reducing power. It is a cofactor ... Read More
Medical Device Labeling Regulations
Prominence and Conspicuousness: According to FDA regulations, all required information on medical device labels must be highly visible and easily understood. This is essential to ensure that users can access important information about the device when making a purchase. The failure of label information to meet these requirements can result ... 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
Tips for Effective Pharmacovigilance Reporting of Adverse Events
As a pharmaceutical professionals, itโs our duty to ensure that any adverse events related to drug use are reported accurately and efficiently. Here are 10 essential tips to enhance the effectiveness of your Pharmacovigilance reporting: PROMPT REPORTING It’s crucial to report adverse events as soon as they are identified. Timely ... Read More
Estimated Time Frames for Obtaining FDA Authorization
๐๐ถ๐ผ๐น๐ผ๐ด๐ถ๐ฐ๐ The approval timeline for a biologic can vary depending on the complexity of the product and the data required to support its safety and effectiveness. ๐ฃ๐ฟ๐ฒ-๐๐ก๐ ๐ฑ๐ฒ๐๐ฒ๐น๐ผ๐ฝ๐บ๐ฒ๐ป๐: 1-2 years๐๐ก๐: 1-2 years๐๐น๐ถ๐ป๐ถ๐ฐ๐ฎ๐น ๐๐ฟ๐ถ๐ฎ๐น๐: 3-7 years๐๐๐ ๐๐๐ฏ๐บ๐ถ๐๐๐ถ๐ผ๐ป: 6 months๐๐๐ ๐ฟ๐ฒ๐๐ถ๐ฒ๐: 6-12 months๐ง๐ผ๐๐ฎ๐น ๐ฎ๐ฝ๐ฝ๐ฟ๐ผ๐๐ฎ๐น ๐๐ถ๐บ๐ฒ: 5-10 years ๐๐ถ๐ผ๐๐ถ๐บ๐ถ๐น๐ฎ๐ฟ๐ The approval timeline for ... Read More
Biological Filing Process to FDA
Biologic filing is the process of submitting an application to the USFDA to request approval for a new biologic product. Biologics are a type of medicine that is made from living organisms or their products. ๐ง๐๐ฝ๐ฒ๐ ๐ผ๐ณ ๐๐ถ๐ผ๐น๐ผ๐ด๐ถ๐ฐ ๐๐ถ๐น๐ถ๐ป๐ด๐ ๐ง๐ต๐ฒ๐ฟ๐ฒ ๐ฎ๐ฟ๐ฒ ๐๐๐ผ ๐บ๐ฎ๐ถ๐ป ๐๐๐ฝ๐ฒ๐ ๐ผ๐ณ ๐ฏ๐ถ๐ผ๐น๐ผ๐ด๐ถ๐ฐ ๐ณ๐ถ๐น๐ถ๐ป๐ด๐: ๐ง๐ต๐ฒ ๐๐ถ๐ผ๐น๐ผ๐ด๐ถ๐ฐ๐ ๐๐ถ๐ฐ๐ฒ๐ป๐๐ฒ ... Read More
Types of FDA Applications for Drugs and Biologics
The Electronic Common Technical Document (eCTD) is the standard, accepted electronic format for the following submission types: An eCTD publishing tool is recommended to automatically create the eCTD sequence folder and file structure. FDA does not recommend specific tool vendors, however, they can be located via internet search. For information ... 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
How to Prevent Medication Error?
A preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional or patient/consumer. Medication incidents can have a devastating impact on: What is a Near Miss? An event that could have resulted in unwanted ... Read More