Managing CMO serialization implementation is a multifaceted process that requires thorough review and planning across functional teams to best understand all the components necessary for success. Thus, it is important for companies to recognize the barriers they will likely encounter during serialization implementation with CMOs — and plan accordingly.
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.
Which parameters must pharmaceutical manufacturers take into account for scale-up? How can Quality by Design be introduced in the development phase?
Why and how Multivariate analysis and Design of Experiments can make the difference in process automation and quality improvements cases.
The history of the mean kinetic temperature calculation in pharmaceutical manufacturing and distribution. Also the regulatory guidance that describes where and when to use the mean kinetic temperature calculation: FDA, EMA, and ICH.
We invite you to view a recorded Humidity Measurement Webinar