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Pharmaceutical storage according to GMP guidelines
Medicines improve and maintain the health of many people and have therefore become indispensable to public health. Appropriate quality standards for the pharmaceutical manufacturing process are essential to ensure the quality, efficacy and safety of medicines.
Good Manufacturing Practice (GMP) is an important part of this, as it focuses on protecting patients by ensuring consistent product quality. For example, the requirements for quality assurance of production processes and environments applicable in the EU are formulated by the European Commission in the GMP Principles and Guidelines and published in the EU GMP Guidelines (1).
Qualification is a fundamental part of the quality assurance system. It's written proof of the suitability of the equipment and premises used and is intended to guarantee the required quality of the medicinal products manufactured (3).
Since the storage of production-relevant components such as primary and secondary packaging materials, active ingredients and excipients, as well as the storage of the drug product ready for distribution, is an important sub-process of the entire manufacturing chain, it's also subject to GMP guidelines and therefore relevant to qualification.
First and foremost, environmental conditions play an important role. Goods should be stored clean and dry (4). Receiving and shipping areas should therefore be protected from the weather. Cleaning facilities should also be available for incoming goods (6).
In addition to general hygiene measures, pest control is also necessary. Both UV lamps and species-specific traps are used, the type, number and location of which should be determined by experts (4).
Appropriate temperature and humidity conditions are also important (4). Temperature and relative humidity are therefore constantly monitored and regulated. Appropriate ventilation, heating and cooling equipment and instrumentation and control (I&C) ensure that the defined environmental conditions are maintained and are tested for suitability as part of the qualification process. Temperature mapping is usually carried out to identify critical areas (coldest and hottest spots). This involves placing a sufficient number of mobile temperature loggers to cover all levels and zones (4). As the amount of heating or cooling required to maintain the defined environmental conditions may vary seasonally depending on the type of storage facility, such temperature mapping can be performed over a defined period in both winter and summer. This will ensure that the ventilation, heating and cooling technology fulfils its role even under seasonal variations.
To ensure that the goods are used correctly, it is also very important to avoid mix-ups during the storage process. Sufficient size and good lighting are prerequisites for ensuring that all operations can be carried out correctly (6). In addition, both goods and storage locations should be clearly labelled and storage processes and material routes clearly defined. There are various forms of storage organisation, for example, to ensure that released goods are separated from those in quarantine. In principle, a distinction can be made between physical segregation and computerised segregation (5).
In addition to warehouse-specific regulations, personnel working in the warehouse must also be aware of and implement general GMP requirements (6). To ensure that all defined processes are adhered to, it is therefore important that access to the warehouse is only granted to appropriately trained personnel. An access control system is therefore an important component and will be assessed as part of the qualification process.
These and many other aspects need to be considered when qualifying storage areas, and should therefore be taken into account at the planning stage. Thoughtful and proactive planning is therefore an important building block for a smooth qualification process.
Bibliography
1. Bundesministerium für Gesundheit. [Online] 23. Oktober 2023
2. Hiob, Dr. Michael. 6.A Anforderungen aus Behördensicht
3. Gausepohl, Dr. Christian. 24.C Lagerungsbedingungen
4. Lagerbereiche. GMP-Berater. s.l. : Mass & Peither AG, 2015
5. Frick, Dr. Christoph. 24.E Qualifizierung von Lagern
6. Gausepohl, Dr. Cristian. 24.A Lagerhaltung
7. U.S. Food & Drug Administration
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