Make sure our current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (cGMP) as well as vendors supplying product specific raw materials unique to the product. Quality agreements are required for the commercial manufacturing of Active Pharmaceutical Ingredients (APIs or drug substances, or their intermediates), as well as finished drug products from a CMO, combination products, and biological drug products. The intent of this webinar is to ensure we gain the proper perspective of the terms related with “manufacturing” which includes processing, packing, holding, labeling operations, testing, and operations of the Quality Unit.
Why Should you Attend
Manufacturing pharmaceutical products or materials may involve many discrete unit operations and activities. The entire process may be conducted by the owner of the drug, or, alternatively, the owner may engage an outside party or parties to complete the entire manufacturing process, or one or more discrete operations, under the contract. In this document, when discussing the roles and responsibilities of the parties to such contractual relationships, we will refer to the party that introduces (or causes the introduction of) a drug into interstate commerce as the Owner of the drug, whether such drug is covered by a marketing application/license or no. In this guidance, outside entities performing manufacturing operations for the product Owner are called Contracted Facilities.
Objectives of the Presentation
Who can Benefit
- Defining the who and what of contract manufacturing including vendor suppliers for specific raw materials
- Establishing responsibilities of critical vendors and CMOs
- Contract manufacturing and quality management
- Documenting contract manufacturing arrangements using the quality agreement or agreements
- Elements of a quality agreement
- Objective evidence to demonstrate compliance
- Contract laboratories are contracted facilities subject to CGMP requirements
- Quality Departments - Quality Control and Quality Assurance
- CMO Leadership
- Production Leadership