“Discover the importance of yield calculation in pharmaceuticals for ensuring compliance with FDA regulations. Learn about challenges, best practices, and how BioBoston Consulting can enhance your processes.”
The pharmaceutical sector must keep generic versions of brand patents available for a consumer using the safest methods. The U.S. Food and Drug Administration (FDA) established regulations in Part 211 of Title 21, Chapter I, Subchapter C to outline the Current Good Manufacturing Practice (cGMP) for finished pharmaceuticals. Calculating Yield— Yield calculation is another important part covered under Subpart F, which helps to determine how efficient and reliable is the drug production. Understanding Orifice Diameter Yield Calculation and its Challenges for Pharmaceutical Manufacturers
Yield Calculation Overview:
Sec. Regulation 211.103 states that at the end of each appropriate phase in the manufacturing, processing, packaging, or holding of a drug product it is necessary to verify the actual yields and percentage yield based on theoretical value. Yield calculation always signifies that the drugs produced are in full accordance with the predetermined standards, protecting both quality and quantity.
Key Challenges:
Yields
Yields are the total amount of product that can be made from a single set of raw materials
Accuracy and Precision: Accurate yields necessitate precise instructions for small process details throughout production. Errors in measurements or calculations can have a major effect on the outcome of yield determination and making it susceptible to inequitable results about the product’s quality and performance.
Yield Determination for Each Phase:
The rule instructs to calculate the yield at the final stages of each manufacturing phase. This requirement makes the holistic process quite intricate because each phase has a unique set of parameters and processes. Best practices: Establish standard procedures for calculating and documenting yields throughout each phase
Independent Verification
Data reliability, and integrity requirements by regulatory stipulates the importance of independent verification. Yield may be calculated by one person, then verified by a second; or yield can be performed by automated equipment independently verified by one person. The introduction of such stringent verification processes can be both a costly and tricky process, with extensive needs for resources and competent independence.
Challenge
The use of automated tools for yield calculation (as per 211.68) provides efficiency and an accuracy advantage. Manufacturers need to confirm that these automatic systems and techniques are dependable and proven (i.e. yield information produced is factual), There are technical and resource challenges to implement and maintain such equipment.
Documentation and Traceability: Proper documentation and traceability of everything is necessary in cGMP compliance. Manufacturers must keep the most minute details of those yield calculations right up, including all raw data, methods, and verification steps. Developing documentation and traceability correctly is a burden on time and resources.
Continuous Process Improvement
Monitoring and analysing yield data over time is necessary to reveal process inefficiencies and results can be used to implement improvements. On the other hand, yield data collection and analysis can be easier said than done especially when dealing with more than a couple of manufacturing processes, raw materials variables that affects it as well as changing environmental conditions.
Conclusion
The quality and consistency of finished pharmaceuticals are crucial to meet the yield calculation regulations of the FDA. Pharmaceutical manufacturers are confronted with different challenges to establish a robust yield calculation process that is reliable, accurate, precise, phase-specific, independently verified, automated and documented process with the capability for ongoing process improvement. Meeting these challenges can be achieved with robust quality management system, technology resources and a relentless focus on cGMP principles. Addressing these challenges will help pharmaceutical companies produce safe and effective drugs of the highest quality.
To discover how BioBoston Consulting can help you, feel free to get in touch with us or schedule your consultation.
