Product Name:Quality Agreements and Third Party Manufacturers
Our Price:$70.00
Availability:In Stock
Product Number:20.015
Product Weight:0.6 lb.

 Product Detail

All products that are produced at a Third Party Manufacturer (TPM) must be in compliance with Quality Policies & Standards, cGMPs, and all other applicable regulatory requirements. It is also required that there be as part of all new and renegotiated contractual business agreements with TPMs, a specific section of the business contract that clearly defines the quality related requirements, and roles and responsibilities of the parties entering the contract. This 14-page guideline was written to provide an outline of what is required to become compliant with GMPs as they relate to TPMs. The contents are as follows: Introduction TPM Selection and Approval TPM Business Agreements Ongoing QA Responsibilities and Support Change Control Standard Quality Agreement SOP Electronic Version As a bonus, we are also including an electronic copy of the Quality Agreement and TPM SOP a $125 value free.

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