GMP Trends and Analyses!

07.11.2023

Quality Standards for Medical Cannabis - Update on Pharmacopoeial Monographs

Currently there is a growing interest in the use of medical Cannabis in the global healthcare sector. Thus, comprehensive quality standards and regulatory measures for these natural substances are needed. Please read more here.

07.11.2023

Are Data Quality and ALCOA attributes equivalent?

The attributes utilized to evaluate the integrity of data and records associated with activities covered by the medicines’ manufacturing practices applicable regulation in the life sciences sector is called ALCOA. It is relevant in other areas, particularly pharmaceutical research, clinical, testing, and the supply chain. Please read more here.

07.11.2023

FDA 483s and Warning Letters concerning Stability Testing

Stability tests are designed to determine how a drug product or active ingredient changes under certain conditions - temperature, humidity, exposure to light - during a specified period of time. Please read more here.

07.11.2023

Safe Handling of Highly Potent Substances

For many years now, the number of Highly Potent Active Pharmaceutical Ingredients (HPAPIs) has been increasing in formulation and administration. Please read more here.

07.11.2023

ICH Q7 Training Week 2022

Finally, in November 2022, the training week was back on-site. For this, many interested participants from a large variety of countries met in Heidelberg together with the speakers to discuss and debate well-established and current topics in the field of chemical and biotech APIs and their legal GMP requirements. Please read more here.

Air-tightness of Cleanrooms and Containment Solutions - Classification, Planning & Testing

The need for standardized definition and testing of the air-tightness of rooms is growing. Please read more here

16.07.2023

Good Distribution Practice Update 2022/2023

This article summarizes some highlights from the GDP area in Europe and the USA. Developments from 2022 and the first quarter of 2023 are considered. Please read more here