GMP or GDP – Would You Have Known?

Excerpt from the GMP:KnowHow Pharma Logistics (GDP)

7 min. reading time | by Simone Ferrante
Published in LOGFILE 14/2025

You might be thinking: “It's clear – GMP applies to manufacturing and GDP to distribution!” But is this distinction always so unambiguous? Unfortunately not, says Simone Ferrante, author of the knowledge portal GMP:KnowHow Pharma Logistics (GDP). From her many years of professional experience, she knows a number of topics where the legal situation is insufficiently harmonized and therefore unclear.
Find out more about the interfaces between GMP and GDP and test your knowledge in today's feature! 

You can find all the important topics relating to GDP and many useful tools such as SOPs, job descriptions and sample documents in the brandnew online portal GMP:KnowHow Pharma Logistics (GDP).

GMP or GDP?

This question is often asked in practice. For a better understanding, take a brief look at both terms:

GMP stands for "Good Manufacturing Practice" and refers to Manufacturing.

Manufacturing is defined as follows in the German Medicines Act (AMG) § 4 Sec. 14:

"Manufacturing is the producing, preparing, formulating, treating or processing, filling as well as decanting, packaging, labeling, and release of medicinal products."

Batch release is therefore the final step in the manufacturing process. All manufacturing steps may only be carried out with an appropriate manufacturing authorisation in accordance with § 13 AMG and a valid GMP certificate. This also includes logistical activities. After batch release by a qualified person (QP), finished products may be put into saleable stock in the warehouse management system. Up to this point, the products must be held in quarantine and GMP requirements must be met.

Even after the importation of medicinal products from a third country into the EEA, a batch release must take place. Consequently, such an import also represents a GMP activity. 

GDP stands for "Good Distribution Practice" and refers to Distribution.

The following definition can be found in the glossary of the EU GDP Guidelines:

"GDP is that part of quality assurance which ensures that the quality of medicinal products is maintained throughout all stages of the supply chain from the site of the manufacturer to the pharmacy or person authorised or entitled to supply medicinal products to the public."

GMP includes GDP

According to Chapter 1 of the EU GMP Guidelines, the obligation to comply with GDP represents an integral part of GMP.

EU GMP Guidelines Chapter 1 Pharmaceutical Quality System

1.8 Good Manufacturing Practice is that part of Quality Management which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorisation, Clinical Trial Authorisation or product specification. Good Manufacturing Practice is concerned with both production and quality control.

The general requirements of GMP are: 

(ix) The distribution of the products minimises any risk to their quality and takes account of Good Distribution Practice;

You can also put it like this:

• Anyone who has to comply with GMP must also comply with GDP because GDP is part of GMP.
• However, not everyone who has to comply with GDP must also comply with GMP because GMP goes beyond GDP.

Delimitation of GMP and GDP

Although GMP includes GDP, the quality requirements must be adapted to GMP or GDP. This is because a fundamental aim is to adapt requirements on the basis of risk. There are more serious quality risks in pharmaceutical manufacturing than in traditional distribution. As a result, GMP requirements are always higher than GDP requirements and must be adhered to more strictly. 

GDP cannot be fulfilled completely independently of GMP. Sometimes, it is impossible to distinguish between GMP and GDP in a clear-cut way. In such cases the decision is at the discretion of the competent authority.

In practice, difficulties may arise when a topic seems at first glance to be GDP-related, yet the EU GDP Guidelines (2013/C 343/01 and 2015/C 95/01) offer no guidance.

Unfortunately, there are a lot of topics that are not sufficiently harmonised. As a result, the executing party (e.g. the logistics service provider) does not have concrete and standardised guidance from the regulator.

GMP:KnowHow Pharma Logistics (GDP) takes a closer look at these topics. Below you will find a few examples.

Handling of goods under Quarantine

GMP or GDP?

• GMP

Where is the problem?

• Medicinal products can only be placed on the market after certification by a qualified person (§ 17 German AMWHV).
  As long as the release to saleable stock is still pending, the goods must be kept under quarantine. At this point, the products may already be handed over to the LSP. The specific requirements in this regard are not harmonised and are at the discretion of the respective competent authority.
  The basic problem here is the definition of placing on the market according to § 4 of the German AMG. Even exhibiting and offering for sale (holding ready) fall under this definition. Storing these products in free stock without a safety measure is, therefore, a criminal offence.

Recommendation:

• These processes are critically important from a regulatory standpoint and require a complete focus. The relevant authorities should approve the procedure.

See more under GMP:KnowHow Pharma Logistics (GDP):

• Chapter 3.2 „Premises“
• Chapter 5.4 „Receipt of medicinal products“ 
• Chapter 5.5 „Storage“

Importation of finished medicinal products

GMP or GDP?

• GMP in the EU
• GDP in Switzerland

Where is the problem?

• In the GDP Guidelines (2013/C 343/01), chapter 5.9 describes exports to third countries. However, there is no chapter on import in the GDP Guidelines.
  Annex 21 "Importation of medicinal products" to the EU GMP Guidelines was published on 16 February 2022.
• The logistics service provider can be the site of physical import without granting the EU market release. However, specific requirements are still not harmonised and are at the discretion of the competent authority.

See more under GMP:KnowHow Pharma Logistics (GDP):

• Chapter „General information about pharma logistics“
• Chapter „Importation“

Storage of products from a third country in a customs warehouse or bonded warehouse

GMP or GDP?

• GDP

Where is the problem?

• Customs law and pharmaceutical law are not harmonised. Both national legislations must be fulfilled.
  This process is not regarded as an import in Germany and by the WHO GSDP (Good Storage and Distribution Practice).
  In Switzerland, however, this is considered an import (HMG, 3rd sec.).

See more under GMP:KnowHow Pharma Logistics (GDP):

• Chapter „Importation“

Do you have any questions or suggestions? Please contact us at: redaktion@gmp-verlag.de