Pre-qualification Activities Clause Samples

Pre-qualification Activities. Objective: ensure we have a robust process by challenging parameters defined as critical for both upstream and downstream. In order to ensure we have a robust process before running the qualification campaign, parameters defined as critical will have to be “challenged” in order to obtain a suitable working range for these parameters. Moreover, some stability studies will have to be conducted on different steps of the process in order to define “holding points”, such as: For upstream part (2 weeks) price € [*] a) stability of the peptide resin b) stability of the crude in neat TFA c) stability of the crude during evaporation step d) stability of the crude after precipitation e) stability of the crude during drying step f) stability of the crude upon storage, etc… For downstream part (3 weeks) price € [*]. Potential critical parameters such as column loading, gradient, chemical stability of fractions in purification and peptide concentration, tray volume, powder homogeneity in lyophilization will have to be assessed and challenged. · Deliverables (4 weeks): Upstream € [*] · Qualification parameter protocols · Qualification parameter - experimental part · Qualification parameter reports · Definition of critical parameters Upstream · Parameter List · Robustness Testing Downstream € [*] · Qualification parameter protocols · Qualification parameter experimental · Qualification parameter reports · Definition of critical parameters Downstream · Parameter List · Robustness Testing Quotation for pre-qualification activities (in Euros €): € 80,000 (Breakdown: 37.5% upstream, 62.5% downstream; duration: 9 weeks with activities performed in parallel).