1. Introduction Mean Kinetic Temperature (MKT) is used in the pharmaceutical industry to evaluate the effect fluctuating temperatures have over time on the efficacy and safety […]
When medical device manufacturers consider placing devices on the market, they face the challenge of understanding the regulatory environment in different jurisdictions and the regulatory requirements […]
Today, Friday, February 24, 2023, the seminar program “Quality management by cloud computing: Comprehensive solution through Master Control application took place with the participation of more […]
At present, technology transfer in general, and transfer analytical method, in particular, is a problems of great concern for factories or laboratories. The transfer of analytical […]
An orphan drug designation is a status delivered by FDA (US) or EMA (Europe) for pharmaceutical drug that has been developed specifically to treat an ultra-rare […]
Overview Patient safety is the primary objective of the Pharmaceutical Quality System (PQS), Manufacturing Authorization holder is required to manufacture safe and effective medicinal products in […]
When medical device manufacturers consider placing devices on the market, they face the challenge of understanding the regulatory environment in different jurisdictions and the regulatory requirements […]
Today, Friday, February 24, 2023, the seminar program “Quality management by cloud computing: Comprehensive solution through Master Control application took place with the participation of more […]
At present, technology transfer in general, and transfer analytical method, in particular, is a problems of great concern for factories or laboratories. The transfer of analytical […]
An orphan drug designation is a status delivered by FDA (US) or EMA (Europe) for pharmaceutical drug that has been developed specifically to treat an ultra-rare […]
Overview Patient safety is the primary objective of the Pharmaceutical Quality System (PQS), Manufacturing Authorization holder is required to manufacture safe and effective medicinal products in […]
On the morning of November 24, the Workshop on “Exchange of experience in upgrading the quality system of a pharmaceutical production facility to EU – GMP […]