Guidance for Industry Q10 Pharmaceutical Quality System

F. 
 Management Review (2.6) 
(a) Senior management should be responsible for pharmaceutical quality system 
governance through management review to ensure its continuing suitability and 
effectiveness. 
(b) Management should assess the conclusions of periodic reviews of process 
performance and product quality and of the pharmaceutical quality system, as 
described in sections IV (3) and V (4). 
G. 
Management of Outsourced Activities and Purchased Materials (2.7) 
The pharmaceutical quality system, including the management responsibilities described in this 
section, extends to the control and review of any outsourced activities and quality of purchased 
materials. The pharmaceutical company is ultimately responsible to ensure processes are in place 
to assure the control of outsourced activities and quality of purchased materials. These processes 
should incorporate quality risk management and include: 
(a) Assessing prior to outsourcing operations or selecting material suppliers, the suitability 
and competence of the other party to carry out the activity or provide the material 
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using a defined supply chain (e.g., audits, material evaluations, qualification). 
(b) Defining the responsibilities and communication processes for quality-related 
activities of the involved parties. For outsourced activities, this should be included in a 
written agreement between the contract giver and contract acceptor.
(c) Monitoring and review of the performance of the contract acceptor or the quality of 
the material from the provider, and the identification and implementation of any 
essential improvements. 
(d) Monitoring incoming ingredients and materials to ensure they are from approved 
sources using the agreed supply chain.
H.