In evaluating implementation of ICH Q10, certain questions may arise for both the sponsor company and a contract manufacturer.
Can you offer insight into some of these issues, looking first at how a company might demonstrate implementation of a pharmaceutical
quality system in accordance with ICH Q10?
Under CGMP, companies should develop procedures governing their quality system. Evidence that process performance, corrective
actions and preventive actions, and changes are appropriately evaluated and implemented are typically requested during an
inspection. Evidence of management reviews should also be available.
FDA's own inspection guidance (7356.002) to investigators requires coverage of the quality system during every inspection.
We expect the quality unit to establish procedures and ensure that effective oversight and monitoring mechanisms are in place
to detect actual or potential quality problems and react in timely manner. We expect management to fully empower the quality
unit with the responsibility and authority to be effective.
What information and documentation of development work would be required at a manufacturing site?
The contract manufacturer should have all necessary drug formula, component, process information, and knowledge to enable
the site to capably perform the manufacturing operation under contract, including any quality-assurance activities associated
with the manufacturing operation. Contract manufacturers should have information on site or readily available to facilitate
appropriate response to new or unexpected product results or process experiences, as well as proper handling of intended or
The agency expects sponsors and contract manufacturers to establish clear communications and effective collaboration to ensure
Will ICH Q10 certification be required?
Will the inspection process be changed either in terms of the inspection itself or related documentation?
FDA already had a quality-systems inspection program in place that is closely aligned with basic principles found in ICH Q10.
There is no current plan to revise the CGMP surveillance inspection manual or change the need for all routine inspections
to cover the quality system.
For further perspectives on ICH Q10 and quality by design for outsourcing, see PharmTech's January 2010 cover story, Quality by Design: Adding Another Dimension to Outsourcing.