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What are Outsourced Activities?

Outsourced activities are any activities that are carried out for you by a third-party.

For all outsourced activities there should be an in-depth written contract in place that clearly lays out the duties and responsibilities of both your company and the third-party in relation to the activity/operation, and it should be signed by both parties. This will ensure that there is no confusion over what needs to be done and how, so that everything gets done correctly. It also means that should there be any debate on responsibilities/duties you can refer back to the contract for the answer. Any concerns regarding the contract (for either party) should be communicated, ideally before it is signed.

Some examples of activities that can be outsourced to a third-party are:

~ Pest control

~ Cleaning services

~ Transport services

~ Warehousing (storage)

~ Security services

Thorough checks will need to be carried out on any company you intend to work with. This will ensure that they are the best company to carry out the tasks you need them for, that they have the correct licences/qualifications and they will know how to be Good Distribution Practice compliant (or are willing to have training), as well as helping you to learn about their reputation.

The work that a third-party carries out on your behalf will impact your reputation as well as their own so it is important for your business that they are effective/successful in their tasks and provide a high standard of service.

It is the responsibility of the RP to guarantee that all checks are completed and detailed contracts are put in place for all outsourced activities before any work is started – they must ensure that both are effective in achieving their purpose. They may delegate this task to another member of staff who is suitably trained but the ultimate responsibility will lie with the RP, especially if something goes wrong, so they should at least oversee and approve the processes to ensure they run smoothly.

Further checks for each company you work with should be carried out based on the time-frame set out in your procedures. You should be consistently monitoring their performance and compliance.

Training, Support and Backup

Our training will give you an idea of what the contract for outsourced activities will need to include for it to be successful (it will vary depending on the task) and how you can carry out effective checks. If you require any training take a look at the training calendar or online courses via the link buttons shown below.

We can provide you with guidance/assistance in creating an efficient contract or carrying out bona fide checks on a company (including audits). Get in touch with us using the the Contact Form below, or call 0330 133 0920 and we can arrange a free consultation to discuss how we can help you.

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Related Courses

£99.00

Warehouse Cleaning and Personnel

Keeping licensed premises clean and hygienic to a standard that meets GDP compliance, is an ongoing task. The Warehouse Cleaning and Personnel course covers all aspects of cleaning and hygiene in a licensed warehouse, and help you and your cleaning team to be efficient in the cleaning procedures, thus aiding compliance to Good Distribution Practice, as well as helping to maintain the Quality Management System (QMS).

£149.00

Outsourced Activities and Responsibilities of the Licence Holder and Responsible Person

This course looks at Outsourced Activities relating to Good Distribution Practice, along with the Responsibilities of both the Responsible Person and Licence Holder. Including areas such as the quality system and risk management with details from the Human Medicines Regulations and the EU Guidelines on GDP.

Coming Soon!

Good Distribution Practice: Chapters 6-10 of the EU Guidance 2013/C 343/01