Quality agreements are comprehensive written agreements between parties involved in the contract manufacturing of drugs that defines and establishes each partyās manufacturing activities in terms of how each will comply with CGMP. These agreements should cover all aspects of the quality and safety of the product, and must include specifics about any changes in the product’s manufacturing, equipment, or other related processes. These agreements are an essential part of risk management, and a regulatory requirement.
A company recently received this 483 observation:
ā¦.. There is no agreement with suppliers, contractors and consultants to notify you of changes in the product or service.
Specifically, my review of the Quality agreements with the firmās suppliers, contractors and consultants revealed deficiencies with 2 of the 7 contracts I reviewed. The firm had not established Quality agreements with all of their critical suppliers.
According to pharmaceuticalonline.com, there are four different types of quality agreements depending on the type of relationship; manufacturing, supplier, vendor, and service quality agreements. Be sure to have the right agreement in place with your supplier.
Every quality agreement must include clear definition of terms, specific time frames, and they must define both parties’ responsibilities. These agreements should also grant the pharmaceutical company the ability to audit the supplier’s facilities. Failure to have these agreements in place with every supplier will likely result in a 483 observation.
It’s also important to make the distinction between a quality agreement, and a general business contract. Your quality agreement does not include pricing, delivery terms, liability limitations, etc. Your quality agreement must be a separate document from your supply agreement.
For more observationsĀ pertaining to medical devices, seeĀ Issue 1054 available today.Ā It also has observations pertaining to manufacturing controls, laboratory controls and sterile manufacturing controls.
Stay in Compliance!Ā SubscribeĀ today!
Recent Comments