The US FDA Quality Agreement Guidance: What You Need to Know
If you work in the pharmaceutical or biotech industry, you`re likely familiar with the concept of a quality agreement. It`s a document that outlines the responsibilities of all parties involved in the manufacturing and supply chain of a drug product. But did you know that the US FDA has specific guidance on what should be included in a quality agreement? Here`s a rundown of what you need to know.
What is a quality agreement?
A quality agreement is a legally binding document between two or more parties involved in the manufacturing, testing, packaging, labeling, or distribution of a drug product. It outlines the responsibilities of each party and ensures that everyone is on the same page when it comes to quality standards and regulatory compliance.
What does the US FDA Quality Agreement Guidance cover?
The US FDA`s guidance on quality agreements was issued in 2016 and covers a range of topics. Some of the key areas include:
– Definition of roles and responsibilities: The guidance recommends that quality agreements include detailed descriptions of the roles and responsibilities of each party involved in the manufacturing and supply chain process.
– Quality specifications: The agreement should specify the quality requirements for the drug product, including testing requirements, acceptance criteria, and quality control procedures.
– Change control: The agreement should outline the process for making changes to the manufacturing process, including how changes are initiated, evaluated, approved, and communicated.
– Complaint handling: The agreement should specify how complaints related to the drug product will be handled, including how they will be investigated, documented, and resolved.
– Product release: The agreement should outline the process for releasing the drug product for distribution, including the criteria for release and the documentation required.
– Records retention: The agreement should specify how long records related to the manufacturing and supply chain process will be retained, where they will be stored, and how they will be made available for inspection by regulatory authorities.
Why is the US FDA Quality Agreement Guidance important?
Quality agreements are an essential part of compliance with regulatory requirements for drug products. They help ensure that all parties involved in the manufacturing and supply chain process are working together to meet quality standards and regulatory requirements. The US FDA`s guidance on quality agreements provides clear recommendations on what should be included in these documents to ensure compliance with FDA regulations and promote the safety and efficacy of drug products.
In conclusion, if you are involved in the manufacturing, testing, packaging, labeling, or distribution of a drug product in the United States, it`s important to be familiar with the US FDA Quality Agreement Guidance. By following this guidance when drafting a quality agreement, you can help ensure that your product meets regulatory requirements and is safe and effective for patients.