As part of a quality risk management system to be applied throughout a drug’s lifecycle, “decisions on the scope and extent of validation and qualification should be based on a justified and documented risk assessment of the facilities, equipment, utilities and processes,” according to the draft.
Principles in ICH Q8, Q9, Q10 and Q11 or other systems guaranteeing at least the same level of product quality and security should also be used to support validation and qualification.
But data supporting qualification and/or validation studies obtained from sources outside of the manufacturers’ own validation programme “may be used provided that this approach has been justified and that there is adequate assurance that controls were in place throughout the acquisition of such data.”
It’s unclear how this draft differs from the EU’s previous guidelines, and Amgen, Roche and others declined to comment on the document.
The updated draft also describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products.
Process validation “should establish whether all quality attributes and process parameters which are considered important for ensuring the validated state and acceptable product quality can be consistently met by the process. The basis by which process parameters and quality attributes were identified as being critical or non-critical should be clearly documented, taking into account the results of any risk assessment activities.”
Batches manufactured for process validation “should be the same size as the intended commercial scale batches and the use of any other batch sizes should be justified. e.g. for a continuous manufacturing process,” the Commission says.
The Commission also says what personnel should do for the validation process. “A formal release for the next step in the validation process should be authorised by the relevant responsible personnel either as part of the validation report approval or as a separate summary document,” it says.
“Conditional approval to proceed to the next stage can be given where certain acceptance criteria or deviations have not been fully addressed and there is a documented assessment that there is no significant impact on the next activity.”