Re-printed from the original at MHRA Inspectorate Blog
This post is aimed at new applicants who are establishing a small wholesale dealers’ operation. This subject is referred to as Quality Management in the EU GDP Guidelines 2013 and is covered in Chapter 1.
As a GDP Inspector, some of the most common questions from new applicants include:
- why do we need procedures?
- how do we write them and what does a procedure look like?
- what are the MHRA expectations of them?
Why do I need them?
EU GDP Guidelines Chapter 1 requires that a quality system is “maintained…… all distribution activities should be clearly defined and systematically reviewed”.
Companies will identify policies. These policies may be required because of adherence to regulatory guidance or requirements.
In simple terms, a procedure is the detail behind the policy, ensuring that the policy will be achieved, by completing the tasks identically – every time.
A procedure should standardise the tasks by defining each step to be undertaken, ensuring staff perform consistently, reducing the chance of error, on every occasion.
A good set of clear and concise procedures provide a valuable framework for a company and its staff. The procedure should be written to communicate clearly, who, what, how, where and when.
Procedures, if meeting the above criteria, can be a valuable source of reference to staff avoiding the need for constant reference and questions.
The key element here is that procedures should be easily accessible and be capable of being followed by any member of staff.
Procedures can also be used as a basis for refresher training material or as a guide to new staff.
Additionally, they can also provide a standard from which staff performance can be assessed.
How do I write a Procedure? What does it look like?
You might want to firstly identify the tasks that require a procedure.
Take “Returns” as an example.
There are two types of returns, ambient and refrigerated. Take them individually and write the process step by step.
Bullet points are a good way of beginning the process although some might prefer a flow chart.
Identify the purpose of the procedure.
Identify who is responsible for undertaking the procedure and a deputy
Then, describe the procedure e.g. using the “Returns” example,
- returns arrive back at the site
- stored in designated and signed area
- examined and sentenced by the designated and trained member of staff
- state the returns criteria
- stipulate the documentation to be completed
- state and describe the final disposition.
What are MHRA expectations?
The procedures should ensure that medicinal products are procured, held, supplied or exported in a way that is compliant with the requirements of GDP.
These procedures should be approved, signed and dated by the person responsible for the quality system. As stated in the guidance, the procedures must be owned, reviewed and controlled to ensure that they adhere to current EU GDP Guidelines and requirements and reflect your business practice.
The procedures should be numbered, given a version number and a review date. They should be available to the staff that need to use them and also the Inspector.
The GDP Guidelines state that;
“the size, structure and complexity of distributor’s activities should be taken into consideration when developing or modifying the quality system”.
At the inspection, the Inspector will provide MHRA thoughts about the quality and scope of your procedures, with consideration to the previous paragraph.
It is important to note that at the inspection, you will be expected to demonstrate ownership and familiarity with your procedures; and they must be applicable to your company and to your proposed business model.
Larger wholesale dealers will have a more sophisticated set of procedures and they will be referred to as a Quality Management System and may be kept electronically.
Remember that procedures are not there simply to satisfy the Inspector and then filed away. Procedures are important documents that should be readily available and used as a valuable source of guidance.