Validating software process
It should normally cover the manufacture of at least three consecutive batches of material.
Validation should be performed under conditions to be used for routine manufacture.
Critical steps are those containing Critical Parameters and/or Critical Activities.
Process validation is therefore required from the first API intermediate stages containing critical steps, through to the stage producing the final API.
Typical cleaning methods include water rinses, acid/base rinses, refluxing solvent washes, high pressure water jets, manual cleaning, rinsing via spray ball, solvent re - circulation (via filtration) and detergent cleaning.
The system must be correctly designed to ensure adequate air and condensate removal, sequencing of the process and maintenance of sterility post - cycle.
For example, dedicated production areas should be considered when material of high pharmacological activity or toxicity is involved (e.g., penicillin, certain steroids or cytotoxicanti - cancer agents) unless validated inactivation and/or cleaning procedures are established and maintained.
Cleaning Methods : Cleaning methods must reflect actual equipment usage, be documented and be carried out to pre - determined acceptance criteria.
For consistency of operation, some sites choose to validate all registered stages.
For outsourced registered stages, it is recommended that at least the final outsourced stage be validated, even if it does not contain identified critical steps.
solvent rinsing via spray ball following the process through the plant/equipment).