"Receiving and dispatch bays should protect materials and products from the weather. Reception areas should be designed and equipped to allow containers of incoming materials to be cleaned where necessary before storage." (EU GMP Guidelines Part I, Chapter 3, Section 3.20).
The guidelines for good storage and distribution practice for medicinal products and active ingredients highlight the importance of protecting goods in storage from the weather. Weather protection must be guaranteed in all areas and during all activities. In exceptional situations, incoming goods can be received outside the building under a canopy roof. However, they must be protected from factors such as sunlight and moisture. For this reason, goods should always be received in the storage building. Before placing goods in their final storage place, they usually have to be cleaned using compressed air or aspiration. The necessary equipment must be provided.
Incoming goods and dispatch areas should always be separated to prevent confusion and mix-ups. In small areas, additional organisational measures are required to minimise the risk of mix-up, e. g. by carrying out receipt and dispatch activities at different times. It is also possible to create separate zones within a handling area (using permanent separation, mobile partitions or chain barriers).
For starting materials that are not stored in a central storage area, e. g. liquids (in tanks) or gases, the building must be designed in such a way that filling and sampling can be carried out without risk. A simple canopy roof is a possible solution.
Regulatory requirements for incoming goods and dispatch are summarised in Figure 1.
Figure 1 Requirements for incoming goods and dispatch
"There should normally be a separate sampling area for starting materials. If sampling is performed in the storage area, it should be conducted in such a way as to prevent contamination or cross-contamination". (EU GMP Guidelines Part I, Chapter 3, Section 3.22)
If sampling is carried out in the storage area, there is always a risk of contamination. Laminar flow boxes (LF boxes) in separate rooms can be used as an alternative to complete removal of the materials from storage. Depending on the degree of automation, the materials can be introduced into this type of cabinet manually or using conveyor belts (integration of the LF cabinet into the linear material flow, see example in Figure 2).
Figure 2 Example of a storage area with integrated sampling
Samples can also be taken in an adjoining room containing the required equipment, e. g. an LF unit. This approach should only be taken in exceptional circumstances or if very few materials are handled because the material flow used here can result in mix-ups.
It goes without saying that only a single batch may be sampled under LF at any one time. Personnel usually has to wear protective clothing during the actual sampling process. After sampling, the LF area has to be cleaned in accordance with defined cleaning instructions (SOP).
The sampling process must be described in detail in SOPs, e.g. the process used during batch or product changeovers, handling of sampling tools, identification, cleaning, etc. Sampling is a process that is usually critical to quality. For this reason, a sampling log book should be maintained. When describing the process, the risk of chemical contamination faced by the staff carrying out sampling should also be taken into consideration.
The way in which sampling is organised depends on the space and time allocated by the company. Identification based on containers, e. g. using NIR, can be carried out directly during sampling for quality control testing under the conditions described above. Another possibility is to carry out a generic quality control and release, followed by an individual identification at a later date. It makes sense to perform this task when the containers are opened (e. g. during weighing). Further aspects of sampling (e. g. requirements that apply if the degree of sampling is to be reduced ) are discussed in detail in 14.A Sampling.
Regulatory requirements that apply to aspects of sampling are summarised in Figure 3.
Figure 3 Sampling requirements
Dr. Christian Gausepohl
Rottendorf Pharma GmbH, Ennigerloh
Diplomingenieur (FH) Chemische Technologie
Infraserv Logistics GmbH, Frankfurt
Der GMP Compliance Adviser beinhaltet: