Compared to the previous version the revised version contains several changes and amendments, like, for example, the following:
The Scope has been changed to IMPs for human use (the first draft included also IMPs for veterinary use). However, some of the principles provided may be applied to other IMPs. The principles should be considered in early phase clinical manufacture.
The Glossary has been amended and moved from the end of the document to section 3.
Spedific aspects for Personnel have been added (e.g. persons responsible for production and quality should be clearly identified and independent, a responsible person should be designated for the release of batches).
Qualification & Validation: In general, the extent may be different to that necessary for routine commercial production and should be based on risk assessment. - Validated or verified cleaning procedures should be followed in order to prevent cross-contamination. Cleaning verification is defined in "Good practices for research and development facilities" as the act of demonstrating that cleaning was done to an acceptable level; for example, between two batches. - Computerized systems should be validated.
Starting materials: Specifications for active ingredients and excipients should be as comprehensive as possible.
Production: Manufacturing should be controlled as appropriate to the phase of development and scale of manufacture. - Sterile product manufacturing should be subject to all GMP requirements for pharmaceutical products. - Enhanced attention should be given to operator training and the qualification of their aseptic technique.
Blinding operations: Maintenance of blinding during the study should be ensured and verification of effectiveness of blinding should be performed and recorded.
Quality unit (including quality control): - Analytical procedures should be suitable for their intended purpose. - Retention samples should be kept until the clinical report has been submitted to the regulatory authorities or at least two years after the termination or completion of the clinical trial (whichever is longest). - Where data and information are stored as electronic records, such systems should comply with the requirements of the WHO guidelines for computerized systems.
Recalls: The recall process should be tested routinely and the results of mock recall should be recorded to demonstrate effectiveness.
Shipping: - Repackaging or relabelling should normally be done by the manufacturer or by authorized personnel at a hospital, health centre or clinic that meet the requirements. - Shipping studies should be performed to establish acceptable shipping conditions, including temperature and light protection. - If required, a temperature monitor should be situated adjacent to the product. - The product shipment should be packaged appropriately to ensure that it will reach its destination intact.
Destruction: - The sponsor is responsible for the destruction of unused, partially used or returned IMPs. These should normally not be destroyed by the manufacturer without prior sponsor authorization. - A Certificate of Destruction should be available.