Article 9U.K.Production
1.The manufacturer shall carry out production operations in accordance with pre-established instructions and procedures.
The manufacturer shall ensure that adequate and sufficient resources are made available for the in-process controls and that all process deviations and product defects are documented and thoroughly investigated.
2.The manufacturer shall take appropriate technical or organisational measures to avoid cross contamination and unintentional mixing of substances. Particular attention shall be paid to the handling of investigational medicinal products during and after any blinding operation.
3.The manufacturing process shall be validated in its entirety, as far as is appropriate, taking into account the stage of product development.
The manufacturer shall identify the process steps that ensure the safety of the subject, such as sterilisation, and the reliability and robustness of the clinical trial data generated in the clinical trial. Those critical process steps shall be validated and regularly re-validated.
All steps in the design and development of the manufacturing process shall be fully documented.