"All of our Good Distribution Practices (GDP) training needs are taken care of by Aptarus. We are able to train our drivers and management team all in the one place."

Harry Hughes
MD FET Logistics


WHAT IS GDP?

Good Distribution Practice (GDP) is the part of quality assurance which ensures that products are consistently transported, cross-docked and handled under suitable conditions.

It is mandatory to use GDP for transport and storage of medicines and active products. These products are often referred to as pharmaceutical products (or pharma products).

GDP principles can also be applied to transport and storage of medical devices, cosmetics, and even certain food supplements.

Person with notebook

LEGISLATIVE BASIS

train anywhere

Within the EU, Article 80(g) of Directive 2001/83/EC refers to the requirement that wholesalers of medicinal products for human use must comply with the guidelines on Good Distribution Practice of Medicinal Products for Human use.

The EU has also published 2 Guidelines that establish the requirements of GDP:

EC Guideline 2013/C 343/01 on GDP for medicinal products
EC Guideline 2015/C 95/01 on GDP for active substances for medicinal products

In the UK, the relevant authority is the Medicines & Healthcare products Regulatory Agency (MHRA).
Transportation companies do not need to apply for a GDP certificate (wholesale license), but they do need to adhere to GDP principle if transporting pharmaceutical products.

GDP PRINCIPLES

GDP principles are a system to ensure the quality, including purchasing, reception, storage and export requirements for pharmaceuticals intended for human consumption.

These principles are organized into 10 chapters in EC 2013/C 343/01 for medicinal products, and 8 Chapters in EC 2015/C 95/01 for active substances.

train anywhere

The 10 Chapters of GDP (Medicinal Products):

train anywhere
  1. Quality Management
  2. Personnel
  3. Premises and Equipment
  4. Documentation
  5. Operations
  6. Complaints, Returns, Suspected Falsified products and product recalls
  7. Outsourced Activities
  8. Self-Inspections
  9. Transport
  10. Specific Provisions for Brokers

The 8 Chapters of GDP (active substances) :

  1. Scope
  2. Quality Management
  3. Personnel
  4. Documentation
  5. Premises and Equipment
  6. Operations
  7. Returns, Complaints, and Recalls
  8. Self-Inspections
train anywhere

HOW CAN APTARUS HELP?

train anywhere

Training is one of the most effective things you can do to ensure that you correctly adhere to GDP standards, and is a key part of the GDP regulations.

We offer a range of GDP courses for roles such as Driver, Manager and Responsible Person to ensure your team are fully aware of their roles and responsibilities under GDP principles.

Need more info?

Still unsure if our courses are right for you - why not find out more by choosing one of the options below:

Contact Us Back to GDP
​