What You Should Expect in GMP Quality Agreements

What You Should Expect in GMP Quality Agreements

October 2nd, 2018 // 6:51 pm @

Have you wondered what the responsibility of your drug company is when it comes to the assurance of GMP quality and safety of products and ingredients that are made at your contract facility? It should be remembered that while the drug company has the ultimate responsibility for caregivers and patients to meet quality and safety expectations, assurance of safety and quality of ingredients and products at the contract facility is shared between the drug firm and the contractor.

Both parties need to stick to expectations that are laid out by relevant guidance and regulations to ensure all products are manufactured according to current GMPs. They also must meet required quality standards and be safe and effective.

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According to FDA guidance on FDA quality agreements, when all parties know their GMP related tasks and manufacturing roles, owners who use contract facilities may get many benefits. Each party that is working in the manufacturer of the drug must ensure compliance with cGMP for all manufacturing activities. This shows how important it is to assemble a good quality agreement plan with clearly defined roles and responsibilities for the drug company and the contract facility.

Some of the most important aspects of a quality agreement to assure GMPs are:

  • All cGMP-related responsibilities and roles of the firm and the contract manufacturer are clear, including final approval for drug manufacturing work.
  • How OOS results and deviations will be determined, studied and solved
  • How changes that could need to be made to the manufacturing processes, analytical methods and equipment are managed
It is key to consider these aspects, as well as other recommendations that are in guidance, when developing and implementing a quality agreement with your contractor. FDA in 2016 published its final guidance for industry in Nov. 2016 on quality agreements with quality manufacturers. The guidance was assembled by CBER, CDER, CVM and ORA. All companies should review this documentation when assembling their quality agreement.
Note that ICH Q7 has useful information about quality agreements with API manufacturing facilities, which are further augmented by quality agreement guidance by FDA. Companies that are developing combination products also should review guidance on cGMP Requirements for Combination Products.
If your facility is being reviewed by an FDA inspector, remember they auditor can review your quality agreement if they choose to. You should have on hand any available quality agreements to provide as requested.
Regarding mistakes in quality agreements, the following are the most common:
  • Roles and responsibilities of the drug company and contractor may not be clear, especially regarding stating and agreeing on QC’s roles and responsibilities.
  • Some agreements may be interpreted that deviate from cGMP standards, and this can lead to a 483 observation in an inspection. Such as a contract manufacturer thinks they need not do an OOS investigation as the drug company is in charge of releasing commercial batches.
  • Mechanism to assess and revise the quality agreement may be forgotten.
  • Some quality agreements could have a commercial contract or business parts, and should only have a focus on quality management items as laid out in US 21 Code of Federal Regulations 211, or ICH Q7 or Q10.

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