The pharmaceutical industry is continuously evolving, with innovations and advancements emerging at a rapid pace. One of the critical areas that has seen significant development recently is cleaning validation. Ensuring that manufacturing processes are free from contaminants is essential for...
- 19 June 2024
- 3 Min Read
The recent updates to the EU GMP Annex 1 shed light on the critical considerations surrounding lyophilization in sterile manufacturing. Lyophilization, often seen as an extension of aseptic processing, introduces unique challenges due to its intricate processes and sensitive product...
- 14 June 2024
- 2 Min Read
Considering that container performance is the primary trait protecting product safety until the point of use, it will continue to receive increasing regulatory attention in the sterile manufacturing space. The updates to Annex 1 align with the regulatory shifts experienced...
- 7 March 2024
- 2 Min Read
