Contracts for Outsourced Activities

What Should Be Included in Contracts For Outsourced Activities?

You will need to have contracts for outsourced activities (for all GDP activities you are outsourcing), to your third-party service providers that are signed by both parties, and that outlines the responsibilities of both the contract giver (your company) and the contract acceptor (third-party). Whenever possible, shared responsibilities should be avoided as they may not be carried out successfully or not at all, due to the increased likelihood of confusion on who should be carrying out the activity and when.

Having Contracts for Outsourced Activities means ensuring that all relevant/required details have been included so they are clear on how to carry out the activities/services correctly, helping to reduce the risk of deficiencies and/or deviations that could negatively impact the quality/integrity of the medicinal products and the safety of patients (end-users).

The most important details that need to be included (where relevant to the outsourced activity), are the storage conditions of the products (e.g; temperature), as these will be needed by third parties when storing/transporting or when performing activities within your site.

For example, if the activity is cleaning, you should put the products that are used for cleaning duties in a separate storage facility to avoid contaminating the medicinal products. This is also needed for pest control providers, so no toxic chemicals are used near products.

Communication

The communication procedures should be laid out showing the third-party who issues deviations to be reported to, and how/where they will need to be documented. You will also need to know who to contact at the third-party in different circumstances (e.g; questions, updates to product conditions, coordinating visits or any problems).

Having a schedule for auditing the third-party’s site/vehicles is a good idea so they are aware of when they will occur. We recommend this before you commence any activities with them and then annually (or after you have become aware of any deficiencies/deviations).

Staying within Compliance

It is very important that you ensure the company’s site and operations are GDP compliant and that they maintain the required conditions for being an outsourced service provider. If they refuse to agree to an audit schedule it should be a big concern; it suggests that they are hiding things and as audits are an important part of ensuring GDP compliance, you should avoid working with them. If they will not allow an audit once the contract has been signed and you are working together, they will have broken the agreement made and you should inform them that you will begin to take action to find a new company, as you cannot guarantee their compliance.

Any actions that will be taken if the contract agreement conditions have been broken should also be outlined so that the third-party are aware of the consequences of non-compliance.

Enquiries

If you need guidance creating contracts for outsourced activities or would like us to perform an audit on a third-party, contact us with your requirements using the form at the foot of this page and we can arrange a free consultation.

Training, Backup and Assistance

For Good Distribution Practice training, visit our online training website to choose from a range of courses, accessible via the link button shown. You can set up accounts either for yourself or for all your staff for free, book places at our popular monthly all-day online GDP for RPs and Management webinar, which will cover all aspects of GDP including outsourced activities.

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