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. 𝗧𝘆𝗽𝗲𝘀 𝗼𝗳 𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰 𝗙𝗶𝗹𝗶𝗻𝗴𝘀 𝗧𝗵𝗲𝗿𝗲 𝗮𝗿𝗲 𝘁𝘄𝗼 𝗺𝗮𝗶𝗻 𝘁𝘆𝗽𝗲𝘀 𝗼𝗳 𝗯𝗶𝗼𝗹𝗼𝗴𝗶𝗰 𝗳𝗶𝗹𝗶𝗻𝗴𝘀: 𝗧𝗵𝗲 𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝘀 𝗟𝗶𝗰𝗲𝗻𝘀𝗲 𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻 (𝗕𝗟𝗔) 𝗣𝗿𝗼𝗰𝗲𝘀𝘀 The BLA…
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:…
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…
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…
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 μg/m3 at an eight hour time-weighted average. Each HPAPIs have specific OEL that must be considered by an institution to…
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 — 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…
Navigating the complex waters of Life Sciences regulations? Two standards tower above the rest – 21 CFR Part 11 and EU GMP Annex 11. Here’s why they’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 isn’t just about checking legal…
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…
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…
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…