Author: Pharma Digest

Biological Filing Process to FDA

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. ๐—ง๐˜†๐—ฝ๐—ฒ๐˜€ ๐—ผ๐—ณ ๐—•๐—ถ๐—ผ๐—น๐—ผ๐—ด๐—ถ๐—ฐ ๐—™๐—ถ๐—น๐—ถ๐—ป๐—ด๐˜€ ๐—ง๐—ต๐—ฒ๐—ฟ๐—ฒ ๐—ฎ๐—ฟ๐—ฒ ๐˜๐˜„๐—ผ ๐—บ๐—ฎ๐—ถ๐—ป ๐˜๐˜†๐—ฝ๐—ฒ๐˜€ ๐—ผ๐—ณ ๐—ฏ๐—ถ๐—ผ๐—น๐—ผ๐—ด๐—ถ๐—ฐ ๐—ณ๐—ถ๐—น๐—ถ๐—ป๐—ด๐˜€: ๐—ง๐—ต๐—ฒ ๐—•๐—ถ๐—ผ๐—น๐—ผ๐—ด๐—ถ๐—ฐ๐˜€ ๐—Ÿ๐—ถ๐—ฐ๐—ฒ๐—ป๐˜€๐—ฒ ๐—”๐—ฝ๐—ฝ๐—น๐—ถ๐—ฐ๐—ฎ๐˜๐—ถ๐—ผ๐—ป (๐—•๐—Ÿ๐—”) ๐—ฃ๐—ฟ๐—ผ๐—ฐ๐—ฒ๐˜€๐˜€ The BLA…

Types of FDA Applications for Drugs and Biologics

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 on eCTD format, please visit:…

Difference Between ICH and USFDA Guidelines
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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, development process, and applicability. ICH…

Risk Analysis and Containment Solutions for High Potent APIs (HPAPIs) Manufacturing

Risk Analysis and Containment Solutions for High Potent APIs (HPAPIs) Manufacturing

The development of technical solutions for this new approach to containment must necessarily start from embracing the same approach to the topic used by the pharmaceutical companies, and adopt the very same risk analysis principles used in the industry to ascertain the hazards for each and every product, from OEB 1 to OEB 5-6 degree…

High Potent APIs (HPAPIs) | Challenges in Development and Manufacturing

High Potent APIs (HPAPIs) | Challenges in Development and Manufacturing

Highly potent active pharmaceutical ingredients (HPAPIs) are pharmacologically active substances that exhibit biological activity at extremely low concentrations, such as daily therapeutic dose of <10 mg or an occupational exposure limit (OEL) of < 10 ฮผg/m3 at an eight hour time-weighted average. Each HPAPIs have specific OEL that must be considered by an institution to…

Excel Spreadsheet Validation in Pharmaceutical Industry

Excel Spreadsheet Validation in Pharmaceutical Industry

What is Excel Spreadsheet? Microsoft Excel is a software program. It is used to create spreadsheets, which are documents in which data is laid out in rows and columns โ€” like a big table. Excel organizes data in columns and rows and can perform calculations on that data using formulas. Spreadsheets that are used to…

Difference Between 21 CFR Part 11 and EU GMP Annex 11
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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. Hereโ€™s why theyโ€™re non-negotiable: Foundation of quality and integrity: Both safeguards ensure the highest standards of Quality, product integrity, and safety in the Life Sciences. Compliance isnโ€™t just about checking legal…

Management of SOPโ€™s Lifecycle in Pharma Industry | Part III

Management of SOPโ€™s Lifecycle in Pharma Industry | Part III

A standard operating procedure generally includes an introduction, background, ownership, instructions, and traceability, all outlined in an agreed-upon format and complete with references, appendixes, and annexures. Although the presentation may differ from the order described here, it must comply with Good Document Practice (GDP). The following standard operating procedure sections are included for completeness; their…

Management of SOPโ€™s Lifecycle in Pharma Industry | Part II

Management of SOPโ€™s Lifecycle in Pharma Industry | Part II

A SOP is a document that provides high-level guidelines for a process. There are different types of SOPs in the pharmaceutical industry. To be most effective, standard operating procedures should be succinct, intuitive, easy to navigate, traceable, and regularly approved. To ensure compliance and traceability to a qualified state are achieved, companies should make approved…

Management of SOPโ€™s Lifecycle in Pharma Industry | Part I

Management of SOPโ€™s Lifecycle in Pharma Industry | Part I

Standard Operating Procedure (SOP) is a document that provides directions on how tasks and processes should be carried out within a company. Standard Operating Procedures (SOPs) are an integral part of the routine operations in the pharmaceutical industry, and every department has its SOPs. SOP management refers to the systematic process of creating, implementing, reviewing…