Skills and Expertise
Processes validation
Let’s hold up as examples :
- Sterile drugs production processes validation according to aseptic or terminal sterilization processes.
- Radioactive drugs production processes validation according to remote handling processes.
- Cleaning validation of the equipments in contact with the drug but also of the formulation tanks.
- Transfer validation of components necessary for an aseptic production through the different pharmaceutical classifications (from non-classified areas to the sterile area).
- Classification of the pharmaceutical production areas (grade D -> A) including a control of cleaning conditions depending on the level of classification.
- Visual inspection before conditioning.
It also implies the writing of the complementary documents as well as the respect of the protocols that support the validation of a sterile drug production process.
- Validation with Media Fill Test (MFT).
- Container Closure Integrity Test (CCIT).
- Sterile filtration validation.
- Study of the « Leachables – Extractables ».
- Stability study.
- Capability study.
- Transport validation.
- Writing of the “Process Validation Master Plan” and of the different procedures (environmental controls, cleaning validation, areas and equipments cleaning, production procedure and adjoining Master Batch Record, etc.).