GMP Perspectives on Working with Contracting Laboratories
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When working with contract testing laboratories, clients must remember that the responsibility for compliance with the GMP or the GLP ultimately lies with the product sponsor. Even if the contract assignes the responsibility to the contract laboratory, the responsibility for assuring compliance lies with the client. Neither can the contract laboratory assume that the client has complied with their responsibilities.
Areas Covered in the Session:
Who Will Benefit:
- GLP requirements that are assigned to a test facility and cannot be transferred back to a client.
- Responsibilities of the sponsor or client.
- The quality agreement and what it should contain to protect the interests of both client and contractor.
- Auditing the contractor for compliance with the GLP ot GMP.
- What is ISO 17425 and what is its effect on contract laboratories and their clients?
- Employees who must deal with contract laboratories
- Employees of contract laboratories who must deal with clients.
- Quality assurance personnel
- Regulatory Affairs personnel.
- Project managers who must select contract testing laboratories.
- Auditors who must deal with contract testing laboratories.
Steven S. Kuwahara , Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steven has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories . Steven has participated in the development of drugs and biologicals through all phases of clinical research and final product production.