Developing Quality Agreements in a Pharma/Biotech Environment

Introduction

Historical contracts in Pharma and Biopharma have consisted of the typical basic contract between the Innovator Company and its Contract Manufacturing, Contract Testing and Contract Filling organizations, without involvement from the Quality function.  As outsourcing extends to new heights through rapid growth and global expansion, this basic contract no longer satisfies the Innovator Company’s total requirements.  As a consequence, Quality Agreements are becoming prevalent in today’s environment to address the quality requirements that are not satisfied by this basic contract.

These Quality Agreements are generally initiated between the Quality organizations of the Innovator Company and its contract function (contract manufacturing, contract testing and contract filling).  Items covered in these agreements typically include:

1. In-process Alert and Action Levels, and final API/product specifications
2. Management of Deviations, Change Control, Out of Specifications, Corrective and Preventive Actions
3. Review of Master Batch records and Batch records
4. Required reporting timeframes to the Innovator Company
5. All regulatory visits

Quality Agreements, more recently, have also begun to supplement the use of Gantt Charts, in that the Agreements are complementing these Charts and further define accountability and responsibility.  The use of these Agreements within a company may assist in removing “silos” and foster work efforts between various Departments, as well as transfers of technology between them since a written agreement exists and defines who is responsible for each area.

The objective of this live and interactive BenAstrum web training course will be to explore Quality Agreement practices and learn how they may limit misunderstandings within your own and Partner organization, as well as enhance communications within these various organizations.

Discussion Points:

• Kinds of Quality Agreements
• How to develop a Quality Agreement
• Elements of a Quality Agreement
• What to include and omit within a Quality Agreement
• Why the Quality Agreement should control quality issues
• Quality Agreement strategies for multiple sites
• How to assure a “win-win” philosophy

Who Can Benefit:

Those who will benefit from this course include Legal, Project Management, Regulatory Compliance, Quality Assurance, Quality Control, Manufacturing and Facilities professionals who are required to develop and maintain Quality Agreements within their organization and with internal and external partners.

Please click here for the course agenda