This course has received CPD accreditation.

Training

Our Outsourced Activities and Responsibilities of the License Holder and Responsible Person course, covers all the expected requirements of both the LH and the RP, in respect to the Quality System. The required compliance objectives are included for outsourced activities, as well as several other required activities.

Outsourced Activities and Responsibilities – Doing It Right

Every member of staff working within Good Distribution Practice at the licensed premises are all equally responsible for maintaining the Quality Management System. However, the License Holder and the Responsible Person have responsibilities that encompasses Outsourced Activities, and the compliance objectives required for this activity.

The essence of Good Distribution Practice (GDP) is that nothing should be happening that isn’t written down as a procedure. Likewise, if it’s written down but it’s not being done, you have a problem. In either case, this would be a classic deviation, and action would need to be taken.

Chapter 1.2 of the EU GDP Guidelines (2013/C 343/01) which concerns the Quality System states:

The system for managing quality should encompass the organisational structure, procedures, processes and resources …be fully documented, and its effectiveness managed.”

“Resources” would include your Outsourced Activities, and it falls to the Responsible Person (RP) and the License Holder (LH) to ensure that correct procedure, due diligence and engagement of the QMS is in place.

The entire operation must primarily concern itself with care of the products, and patient safety. To that end, the process of outsourced activities also has to involve procedures and protocols that are conducive to the QMS, and GDP compliance.

Outsourced Activities poorly undertaken may mean:

~ Non-compliance of contract receivers

~ Poor services rendered within your premises

~ Insufficient equipment servicing

~ Poor documentation by the contract receiver or your company

~ Incorrect materials used, such as cleaners using perfumed disinfectants within the storage area

~ Poorly laid out contracts ie; no clear parameters as to required services, or lack of specific detail

The License Holder needs to know that anyone contracted in to service the premises or equipment within it, have met the same GDP requirements that the premises operates under, because among the LH’s responsibilities is a requirement to ensure that the building is fit for purpose. This means that only companies that are checked, registered, approved and audited if necessary, and that meet the GDP requirements are permitted to operate on the premises.

“Where can I go to get help?”

Paradigm Shift Consulting have a comprehensive training platform, which includes a course specifically for License Holders and Responsible Persons. The course is clearly laid out and well priced. Successfully completing the course will produce a certificate valid for 12 months which is presentable to inspectors as valid evidence of training.

Everything that Paradigm Shift Consulting does, is designed to help you do your job correctly and in a way that is GDP compliant.

We want to see your business work in the interest of patient health and safety.

Get In Touch

Are you having difficulty understanding your responsibilities? Are you “getting lost” in the regulations for your role? Are your instructions not being followed through too often? Or perhaps you are not actually trained, which is a serious problem when inspection occurs? If you’re just getting started, train up immediately, as you cannot engage your role and responsibilities without initial certificated GDP training (EU GDP Guidelines 2013/C 343/01, Ch.2.4, para 1).

You can call us anytime between 9am and 5.30pm GMT for advice, or contact us with your enquiry using the form below, quoting “Responsibilities of the LH and RP” in your message.