Contracts for Outsourced Activities

Contracts are a requirement when working with a third-party service provider (outsourced activities), to be signed by you (the contract giver) and the service provider (contract acceptor), which makes it clear what the responsibilities and duties of both parties are. You should avoid having shared responsibilities as this can cause confusion leading to tasks not being performed effectively or at all.

Contracts: Making them concise

All details required should be included to prevent activities/services being performed incorrectly and to reduce deficiencies and/or deviations that could impact the products’ quality and pose risks to patient safety. This includes for example the conditions the products must be kept at, the temperature, and when being stored or transported by a third-party.

If the service provider is a cleaner you should outline the cleaning products that can and cannot be used to avoid contamination. This also goes for pest control providers to ensure that no toxic chemicals are used.

The procedure for communication should be made clear to ensure that any issues/deviations are reported and documented correctly by the third-party; the responsible person (RP) needs to be informed and it needs to be reported as soon as possible, which ensures that your company knows who needs to be contacted in any circumstances (e.g. questions, updates to conditions of the products, arranging visits or reporting issues).

We recommend that you include audit schedules within the contracts, e.g. an annual audit of their site and/or vehicles (where relevant), as you will need to ensure that they are in Good Distribution Practice compliance and maintaining the correct conditions.

If they will not agree to this, it should be a big red flag; they should not be hiding anything and should understand that audits are an important part of Good Distribution Practice compliance with the EU Guidelines. If they refuse an audit when the contract has been signed, this is a break of the agreed terms and you should start to take actions to find a new company and cease working with the current one.

It would also be wise to include the actions that will be taken in any circumstance where contracts are broken. What these will be is your choice and they can vary from one situation to another, but you must make it clear and stick to what is included.

Assistance and Support

We can help you to ensure that you have included everything needed for your contracts to be compliant and effective. Get in touch with us using the Contact Form to arrange a free consultation, or call us on 0330 1330 920

Take a look at our online Good Distribution Practice training courses via the link button below. Look for the course on Outsourced Activities which is associated with this topic.