Quality Agreements for Pharmaceutical Outsourcing

A quality agreement is a regulatory requirement that helps to establish and define the roles and responsibilities of all parties involved in the process.

As defined by the US Food and Drug Administration (FDA), a quality agreement, or quality technical agreement, is a comprehensive written agreement between parties involved in the contract manufacturing of drugs that defines and establishes each party’s manufacturing activities in terms of how each will comply with CGMP (current good manufacturing practices). A quality agreement addresses items that include the safety, potency, and purity of a product.

This agreement clarifies precisely what is expected of both parties and who will be responsible for all aspects of the project. Quality agreements are required by medical device regulations and various quality standards established by the International Organisation for Standardisation (ISO).

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has brought together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines. There are four types of quality agreements: manufacturing, supplier, vendor, and service quality agreements, each tailored to address the relevant aspects of the particular type of relationship. Here’s a look at three ICH guidance documents containing relevant CGMP recommendations dedicated to contract manufacturing agreements.

Good manufacturing practice guidance for active pharmaceutical ingredients

This recommends that owners evaluate contract facilities to ensure that contractor sites comply with CGMP for specific operations. Owners should have detailed written agreements with contractors that define their manufacturing responsibilities.

Quality Risk Management

The two primary principles of quality risk management are:

  • The evaluation of the risk to quality should be based on scientific knowledge and ultimately linked to the protection of the patient.
  • The quality of the risk management process should be commensurate with the level of risk.

Pharmaceutical Quality System

A Pharmaceutical Quality System (PQS) is a management system to direct and control a pharmaceutical company in terms of quality. The processes should incorporate quality risk management and include critical activities such as:

  • To maintain a system that allows for assessing the suitability and competence of potential contractors before outsourcing operations.
  • Defining the manufacturing responsibilities for quality-related activities of the involved parties.
  • To develop and use effective monitoring and control systems for process performance and product quality.
  • To identify and implement appropriate product quality improvements.