Drinking water is the basis for producing water for pharmaceutical purposes in all national pharmacopoeias. What was long prohibited in the EU has been a reality for the past two years. …more
Quality Risk Management (QRM) is a systematic process for assessing, controlling, communicating and reviewing risks that affect the quality of a medicinal product. An efficiently implemented quality risk management system (QRM) ensures the quality of products throughout the entire life cycles and is an enabler of the Pharmaceutical Quality System (PQS). …more
Which implications will EU GMP Annex 1 have for sterile fill/finish processes? How will it change the way we work in the pharmaceutical industry? And which technologies are best suited? …more
It´s a win-win situation for everyone involved: Valicare s.r.o. moved into new premises together with Heitec Slovensko, spol. s.r.o. at the beginning of the year.
ATMPs are exceptional because they offer groundbreaking new opportunities to cure broad indications such as cancer with mechanisms naturally available in the body and without serious side effects.
No market introduction without validation. In this interview, Dr Claudia Papewalis and Dr Hans-Georg Eckert from Valicare GmbH explain what needs to be taken into account. …more
Only a few decades ago, in the pharmaceutical industry, it was an acceptable practice to verify packaging machinery only by observing equipment run and checking basic functions. Since the 70’s, the industry has gone through a major change. Many regulations, standards, and guidelines that govern CQV (Commissioning, Qualification and Validation) practices were put in place. With that said, the commensurate level of adaptation was required. …more