Frequently Asked Questions

Although packaging may seem like an activity that belongs to the distribution side of things, it’s a manufacturing operation as far as the GMP is concerned. This also applies to labelling.

Packaging and labeling are considered Good Manufacturing Practice (GMP) activities because they are critical steps in the manufacturing process that ensure the correct product is contained in the appropriate package and is accurately labeled. This is essential for ensuring patient safety, product identity, strength, purity, and quality. GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff.

Specifically, GMP for packaging and labeling includes, but is not limited to:

• Ensuring that labels are correct and legible, to avoid mix-ups and misidentification of products.
• Verifying that packaging materials are suitable to protect the product from contamination and degradation over its shelf life.
• Ensuring that the product is packaged and labeled according to the approved specifications and in a way that maintains its quality throughout the shelf life.

Good Distribution Practice (GDP), on the other hand, starts once the product has been released for distribution and is concerned with the proper distribution of medicinal products for human use. GDP ensures that the level of quality determined by GMP is maintained throughout the distribution network, so that authorized medicines are distributed to the end user without any alteration of their properties.

GDP activities include:

• The proper transportation and handling of pharmaceutical products.
• The storage of pharmaceutical products in suitable conditions.
• Ensuring that the distribution of pharmaceutical products is conducted in accordance with the legal requirements and with an adequate record-keeping system.

In essence, GMP is focused on the correct creation and packaging of a safe and high-quality product, while GDP ensures that the product's quality and integrity are maintained through the entire supply chain until it reaches the consumer.

For the EU GMP – Google: “Eudralex Volume 4”

For the U.S. FDA GMP – Google: “21 CFR part 211”

For the WHO GMP – Google: “WHO TRS GMP”

For the PIC/s GMP – Google: “PICs gmp guide”

Updates to these guidelines are made on a regular basis by the regulatory authorities and industry organizations. Be sure to always use the latest version of each GMP/GDP guideline.

You need a storage facility if you have "holding" on your license, but it doesn’t have to be your own warehouse. Many companies applying for a wholesale (WDL) license have a third party logistics organization that perform the warehousing function.

The Qualified Person releases medicine for the manufacturer. The QP checks lab results, batch documentation and checks the medicinal product against the dossier. With the QP’s approval, a product may be sold on the market.

The Responsible Person determines if products may be released from the warehouse, for the distributor. A QP certifies production, the RP certifies that the product has been stored and handled according to it’s specifications.

If the Responsible Person can verify that these conditions have been met, the product may be distributed. If not, the product remains in the warehouse’s quarantine section.

You are allowed to export medicinal products to the European Union if you meet a number of conditions. The two most important conditions are:

1. You have the EU GMP implemented, and an EU GMP certificate (for finished products).

2. You have an importer in the EU, this can be any company with a manufacturing and import authorization located in the EU that wants to import your product.

This depends. If you export an Active Pharmaceutical Ingredient, you will receive a QP declaration and can use the QP declaration to export to your importer. You will always be audited by your importer in the EU against the EU GMP. If you pass the audit, they may import your product.

This does not imply you will be inspected by an EU government. Depending on the importance and risk of your product, you may be audited by your importer and by an EU GMP inspector, but this is not always the case.

Only if you have been inspected by an EU GMP inspector can you get an EU GMP certificate. There is no way to influence the government’s decision whether or not to inspect you.

If you export a finished product, you will need an EU GMP certificate to export to the European Union. You will also be inspected by your importer.

This is different for every company, it depends highly on the complexity of the product(s) you produce / distribute, your facilities and your equipment.

As a general rule of thumb, it takes about 9 to 12 months for greenfield projects and up to 24 months for brownfield projects. If you already have ISO9001, U.S. FDA GMP or WHO GMP implemented, these timelines may be significantly shorter.

Although we cannot certify you ourselves, we can provide support to help you achieve EU GMP certification. No commercial organization can provide EU GMP certification. Only competent authorities can. In the Netherlands, the competent authority is the Inspectie voor de Gezondheidszorg en Jeugd (IGJ) – https://igj.nl