Are you confident on your outsourcing operations?

Outsourcing is a common practice in the Pharmaceutical Industry, but it can be the source of risk for your business. Even more, with the adoption of outsourcing being ever more popular, the oversight of these activities becomes increasingly difficult. Read more about this crucial aspect of modern pharmaceutical production in the article below.

The scope of outsourced activities in the production or operation of pharmaceutical products is broad and can cover every stage of the supply chain. These include contract laboratory testing, qualification and validation activities, but also maintenance and calibration of equipment. It is also found in the assessment and procuring of raw materials, in transport, storage and distribution and in QP batch release activities. Other activities where outsourcing is common are document archiving, sample retention and third party investigational medicinal products. In reality, even pharmacovigilance, sales and marketing, IT Infrastructure and administration are regularly outsourced.

This carries some risk for the owner company, due to the externalization of core tasks and processes, and, as such, any outsourced activity covered by the GMP Guide should be qualified, appropriately defined, agreed upon, and controlled in order to avoid misunderstandings that could result in a product or operation of unsatisfactory quality. The way this is safeguarded is by signing a written contract between the Contract Giver and the Contract Acceptor which clearly establishes the duties of each party.

The importance of having a bullet-proof agreement cannot be overly exaggerated, as all Marketing Authorization Holders (MAH) retain overall responsibility for outsourced activities. This means understanding that activities can be delegated, when the MAH acts as the Contract Giver, but the entity responsible for the product or operation is still the Marketing Authorization Holder.

It is, therefore, critical that the Contract Giver and Contract Acceptor work closely together, establishing an active and ongoing partnership that values open communication, proactive collaboration, and a strong, mutually beneficial relationship. This includes the requirement to establish and document the criteria for quality performance from the outset, as well as identifying quality problems and corrective actions on an ongoing basis.

Furthermore, it is vital that the Quality Management System of the Contract Giver clearly states the way that the Qualified Person exercises his full responsibility, as the pharmaceutical quality system of the Contract Giver should include the control and review of any outsourced activities .In sum, the Contract Giver is ultimately responsible for ensuring processes are in place to ensure the control of outsourced activities but, nevertheless, it is required of the Contract Acceptor to be able to satisfactorily carry out the work ordered by the Contract Giver, by operating in adequate premises, with approved equipment, knowledge and competent experienced personnel.

Ultimately, Outsourced Activities should be subject to an elaborate and concrete Standard Operating Procedure that addresses all possible scenarios. Only this way is it possible to ensure working correctly, which, in turn, will help avoid any sanctions by the authorities.

Also, don’t forget that, you can keep up to date with regulations and ensure correct quality management by drawing on our expertise. Make sure you are on the winning side of outsourced activities and sign RC REDOL as your partner in this journey. Contact our team today and access the experience and know-how necessary for your organization to succeed.

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