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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…

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…

How to Create a Validation Master Plan?

How to Create a Validation Master Plan?

Validation master plan (VMP) is a high-level document that summarizes the manufacturerโ€™s overall philosophy and approach, to be used for establishing performance adequacy. It provides information on the manufacturerโ€™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…

Criteria of Maintaining Audit and Inspection Readiness in Pharmaceutical Industry

Criteria of Maintaining Audit and Inspection Readiness in Pharmaceutical Industry

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…

References for Good Pharmacy Practice

References for Good Pharmacy Practice

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

CAPA Process Steps in Pharmaceutical Industry
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CAPA Process Steps in Pharmaceutical Industry

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…

Microbiological Data Integrity Issues and Control Strategies
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Microbiological Data Integrity Issues and Control Strategies

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…

Deviation in Pharmaceutical Industry
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Deviation in Pharmaceutical Industry

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…