Given the complexities involved and time required for assessment and decision-making activities, it is imperative to start working toward meeting the EU’s Falsified Medicines Directive (FMD) standards immediately, leveraging previous efforts for compliance with other market regulations.
The next milestone for manufacturers, November 27, 2017, is the date by which pharmaceutical manufacturers are required to print a unique product identification code on all Rx units of sale and homogenous cases distributed domestically.
Artesan Pharma Gmbh & Co. KG in Lüchow, Germany, demonstrates how an effective program of serialization, i.e. the traceability of medicines, can successfully be put into practice in today's pharmaceutical industry.
If you were to take a look at the criminal statistics of any given country, you would soon gather that counterfeits, imitations and fake products are on the rise among international criminal offences. Virtually all sectors have been affected; whether the electronics industry, the pharmaceutical industry, the automotive industry or the capital goods industry. It is an alarming development that has led governments and international organizations to draw up laws and measures against this growing crime.
Batch processes are common in pharmaceutical, biopharmaceutical, food, beverage and chemical industries. When building models across various batches one may often encounter varying batch lengths and the batches may start from various relative points of time in a chemical context. Batch Modeling is important for process development and understanding the process for batch similarity and why some batches give a product quality outside the specifications.
Efficacy, safety, immunogenicity and manufacturability issues play a large role in the high attrition rate of biopharmaceutical candidates each year. To help reduce the risk of failure, tools to address the developability of preclinical candidates have been established.
The biopharmaceutical market is undergoing tremendous transformation. Speed to develop and manufacture product has become a critical driver with increased competition and the pressure to be first to market. New process technologies, advances in cell line development and more targeted and complex therapeutic classes have created a challenging biopharmaceutical manufacturing environment with new capacity requirements.
Join this webinar to learn more about this unique approach and how you can benefit from it in different situations. Our Chief Scientific Officer will share the theory and background behind the solution and demonstrate how Unscrambler® X Batch Modeling from CAMO can improve the way we manage time-dependent processes and as an effect, get better quality control, detect events early and overall help improve quality of products and processes.