|Product Name:||Quality Agreements and Third Party Manufacturers|
|Our Price:||$70.00 |
|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:
TPM Selection and Approval
TPM Business Agreements
Ongoing QA Responsibilities and Support
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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