What is GMP (Good Manufacturing Practice)?
GMP stands for Good Manufacturing Practice: a set of guidelines for quality assurance in production and storage. GMP ensures that products are consistently manufactured and managed in accordance with established quality standards. The system is mandatory in the pharmaceutical sector and also applies to food and food-contact materials.
The basic principles of GMP
GMP is based on a number of established pillars that are common to every sector:
Documented procedures describe every process, from the receipt of raw materials to product release.
Trained staff work in accordance with these procedures and record any deviations.
Clean, controlled areas prevent cross-contamination and contamination.
Validated processes and equipment deliver demonstrably consistent results.
Full traceability ensures that every batch can be traced back to its raw materials and the time of production.
The aim is always the same: not to check quality retrospectively, but to build it into the process itself.
GMP in the pharmaceutical industry
In the pharmaceutical sector, GMP is a legal requirement and is regulated most strictly. The European GMP guidelines are set out in EudraLex Volume 4.
Pharmaceutical GMP sets requirements for cleanrooms, air handling, batch documentation and release by an authorised person. Storage and internal transport also fall within its scope.
For distribution, GDP (Good Distribution Practice) applies in addition. This guideline extends the GMP principles to warehousing and transport, including temperature control and the containers in which medicines are transported.
GMP for food and food contact materials
Manufacturers of food contact materials also operate under GMP. Regulation (EC) No 2023/2006 requires a quality assurance system for anyone who manufactures or processes these materials.
For a crate manufacturer, this means, amongst other things, controlled selection of raw materials, clean production areas and documented process control. This ensures that food-grade material remains food-safe in the end product.
GMP in storage and logistics
GMP does not stop at the production line. Storage conditions, the cleaning of containers and the separation of goods flows are equally covered by the system.
Packaging and crates play a dual role in this regard. They protect the product from contamination and must themselves be cleanable and traceable.
Porous or damaged containers pose a GMP risk. Smooth, sealed plastic surfaces are easy to clean and inspect.
What a GMP audit checks
An auditor checks whether the system is correct on paper and whether the shop floor is acting in accordance with it. Document review and a site inspection therefore always go hand in hand.
Typical checkpoints include batch documentation, the calibration of measuring equipment, cleaning records and the handling of non-conformities. Storage conditions and the condition of containers and packaging are also examined.
Prepare by carrying out internal audits yourself. Those who identify and resolve their own non-conformities before the external auditor arrives demonstrate precisely the effective quality culture that GMP is intended to foster.
How GMP relates to HACCP and ISO
GMP, HACCP and ISO standards are often used interchangeably, but each has its own distinct role. GMP sets out the basic requirements: clean premises, trained staff and controlled processes.
HACCP builds on this with a risk analysis for each product and process. Without a functioning GMP foundation, an HACCP plan is of little value, as the fundamental hygiene standards would already be lacking.
ISO 22000 and schemes such as FSSC 22000 combine both into a certifiable management system. A supplier with such a certificate thereby demonstrates that GMP and HACCP are structurally guaranteed.
How to apply GMP to your choice of packaging
Choose containers that can demonstrably withstand your washing process, including temperature and cleaning agents. Request specifications regarding material, temperature range and service life.
Also ensure that every crate is identifiable via barcode or RFID. Traceability at the carrier level makes batch tracing in the event of a recall considerably faster.
Finally, ask your supplier about their own GMP assurance. A container produced under controlled conditions will not introduce contamination that your own system then has to deal with.
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