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…
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…
Validation master plan (VMP) is a high-level document that summarizes the manufacturer’s overall philosophy and approach, to be used for establishing performance adequacy. It provides information on the manufacturer’s qualification and validation work programme and defines details of and timelines for the work to be performed, including a statement of the responsibilities of those implementing…
To maintain audit and inspection readiness at all times in pharmaceutical industry, following criteria are to be maintained: 1. Clear Communication Channel 2. Document Control and Management 3. Effective Training and Competency Programs 4. Robust Change Control Processes 5. Real-time Monitoring and Data Analytics 6. A Culture of Continuous Improvement To do this, create goals…
Introduction to Good Pharmacy Practice (GPP) Patient Care and Counseling Medication Safety and Quality Assurance Pharmaceutical Supply Chain Management Ethical Considerations in Pharmacy Practice Professional Development and Continuing Education Pharmaceutical Legislation and Regulatory Compliance Information Management and Technology in Pharmacy Practice Read also: Compounding Pharmacy Violations Which Put Patients at Risk
Fentanyl patches are used to relieve severe pain in people who are expected to need pain medication around the clock for a long time (chronic pain) and who cannot be treated with other medications. Fentanyl is in a class of medications called narcotics. It works by changing the way the brain and nervous system respond…
Each pharmaceutical manufacturer shall establish and maintain procedures for implementing corrective and preventive action (CAPA). And the procedures must ensure all requirements of CAPA subsystem are met. CAPA Subsystem in Context CAPA Process CAPA Sources Internal Sources External Sources CAPA Process Steps 1. Analyze Data Ensure all quality data sources are defined and analyzed to…
The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. FDA 21 CFR Part 211 covers the areas for finished drug products, such as labeling, production processes, equipment management and personnel. Subpart A – General…
Microbiology lab is manual process based lab, less automation than chemistry lab, less regulatory guidance for microbiologist so that DI issue is the major concern in Microbiology lab. The sterility test, the bacterial endotoxin test and microbial enumeration test which involves counting microbial colonies are mostly prone to DI issues. Common DI issues in microbiology…
It causes a big confusion to understanding the occurrence of incidence and deviation in pharmaceuticals. In this article we briefly discuss on types of deviation and management of deviation. Deviation Terminology When we have any written procedure like standard operating procedure, protocol, standard test procedure, BMR etc. and someone works against this, then it is…