Assuring proper oversight and execution of all aspects of a Supplier Management Program is a critical activity,�which can easily become quite time consuming.�Quality Compliance Partners, Inc. (QCP, Inc.)�can assist you�with your US and International supplier management needs.�

As a Sponsor, you may outsource manufacturing, packaging, testing, distribution or related activities. Howev-�er, regulatory authorities view your company as ultimately responsible for product quality even if the activities�are performed by an outside supplier. FDA and other international agencies are increasing their scrutiny of�Supply Chain Management, including Supplier Selection and Qualification Programs, Quality Agreements, and�Supplier Change Control. Cold Chain Management is also receiving increased scrutiny.�

Therefore, Sponsors must have adequate control over their Supply Chain as well as individual Suppliers. Key�aspects of a successful Supplier Management Program include: Supplier Selection, Supplier Qualification,�Qualification Audits and Routine Audits, Quality Agreements, Person-In-Plant Activities, Technical Transfer,�and a variety of on-going Supplier Management activities.�

Our supplier management services, include, but are not limited to:�

ü� Supplier Selection and Qualification�ü� Quality Agreements�ü� On-going Supplier Management�ü� Person-in-Plant�ü� Technical Transfer�

Details of these services are located on the back of this flyer.�

Copyright © 2010 Quality Compliance Partners, Inc.�

Quality Compliance Partners, Inc.�

5519 Clairemont Mesa Blvd. #290�San Diego, CA 92117�www.qualpartners.com�

Copyright © 2010 Quality Compliance Partners, Inc.�

Supplier Selection and Qualification�

Due Diligence/Technical Visits� Qualification Audits� Development of Supplier Selection and Qualification Programs/Procedures�

Quality Agreements�

Authoring/Review of Quality Agreements� Management of Quality Agreement Negotiations with Suppliers� Development of Quality Agreement Programs/Procedures�

On-going Supplier Management�

Quality Agreement Compliance� Routine Audits�

Batch Record Reviews� Change Control�

OOS Investigations�Deviations/CAPA�Management/Review of Investigations�Stability Data Review/Trending�Routine Communications�Periodic Quality Reviews�Annual Product Review Reports�

Person-in-Plant�

Observation/Management of:� Manufacturing/Packaging/Testing Activities� Equipment/Process Validation Activities�

On-Site Record Review (Batch Records, Change Control, Validation Protocols/Reports)�Technical Transfer Project Management�

Technical Transfer�

Identification of Project Requirements� Development of Integrated Project Plans� Management of Manufacturing Process/Analytical Methods Transfer� Review of Documentation Supporting Technical Transfer�