Pharma Digest
Coloring Agents in Pharmaceutical Industry
Coloring agents are used mainly to impart an elegant appearance, identification and protection to: Color Index Number (C.I. No.) is the identifier number of color โdyeโ or โlakeโ. Example Dyes vs Lakes Regulations 3 main sources to set specification of dyes Common Tests of Dyes Common Tests of Lakes Same ... Read More
Design of Experiments (DOE) in Drug Formulation Development
In pharmaceutical industry, the Design of Experiments (DOE) stands as a pivotal tool, systematically guiding the exploration and optimization of critical processes. By efficiently analyzing multiple factors and their interactions, DOE empowers the industry to enhance product quality, ensure consistency, and meet stringent regulatory requirements. Its strategic application contributes to ... Read More
Data Quality Framework (DQF) for EU Medicines Regulation
Data Quality (DQ) In general terms, quality is defined as an attribute of a product or service that defines the degree to which it meets customer and other stakeholder needs within statutory and regulatory requirements or its fitness for intended use. Where Data quality is defined as: โfitness for purpose ... Read More
Difference Between Batch Record and Master Batch Record
To ensure quality and safety in pharmaceutical production, Good Manufacturing Practices (GMP) require detailed documentation of production processes. What is a master batch record? A master batch record (MBR), also known as a master production record (MPR) is a document that contains the approved ingredients, formulation, and instructions guiding the ... Read More
Pharmaceutical Quality by Design Tools
Prior Knowledge Knowledge may be defined as a familiarity with someone or something, which can include information, facts, descriptions, and/or skills acquired through experience or education. The word โpriorโ in the term โprior knowledgeโ not only means โprevious,โ but also associates with ownership and confidentiality, not available to the public. ... Read More
Phases of a Technology Transfer Project in Pharmaceutical Industry
The technology transfer project plan can be divided into four different phases. These include: Phase I: Project initiation During the initiation phase of the project, a unit normally identifies the need for the technology transfer. This may be due to a lack of capacity, a transfer from development to commercial ... Read More
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
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
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