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Inspection procedures

 

Here you will find answers to the following questions:

  • What can be at the focus of inspections?
  • Which inspection procedure is appropriate when?

It must be possible to carry out inspections in a foreseeable period of time. To this end, the object of the inspection must be narrowed down in advance. This can be carried out on the basis of the system, product, procedure or area.

1 System-based

Figure 18.B-1 Examples of systems

System

Elements (selection)

Purpose

Water supply

Filters, UV unit, ion exchanger, reverse osmosis unit, pumps, holding tanks, pipes, valves, withdrawal stopcocks, disinfection equipment, etc.

Production of purified water

Ventilation system

Aspiration points, filters, flaps, motors, ducts, heating, humidifiers, grating, etc.

Compliance with temperature, humidity and particle limits in the production rooms

Compressed air supply

Aspiration point, filters, compressors, water/oil separator, valves, withdrawal stopcocks, etc.

Production of compressed air intended to be in direct contact with the product and in accordance with a defined specification

Computer-assisted system

Servers, switches, hubs, coaxial cables, PCs, software, production environment, etc.

Electronic data processing, regulation and control of machines

Quality assurance system

Organisation charts, job descriptions, QA manual, SOPs, etc.

Ensuring a defined quality

Systems are interrelated or interactive elements which, as a whole, form a unit with a joint purpose. The functionality of systems is reviewed by assessing the individual elements and their interaction with each other. System inspections include the inspection of the areas and procedures that are crucial for the functionality of the system. Examples of systems are given in figure 18.B-1.

2 Product-based

With product-based inspection, the development of a product or a group of comparable products is traced from the raw materials to the secondary packaging. One or more batches of the product are checked on the basis of the application file for marketing authorisation. Here, the documents specified in figure 18.B-2 form the basis for the review. Manufacturing areas and procedures are included in the inspection to the extent that they are relevant for the product. This inspection type is usually used on contract manufacturers by contract givers.

Figure 18.B-2 Focuses of product-based inspections

Focuses of product-based inspections

  • Specifications of the raw materials and packaging materials
  • Standard operating procedures (SOPs)
  • Manufacturing instructions/record
  • Equipment logs
  • Sampling procedures
  • In-process controls of intermediate products and bulk
  • Testing procedure/record
  • Release procedure

3 Procedure-based

Procedures are activities that are carried out in a specific way. Their execution method is usually described in procedural instructions.

On the one hand, procedure-based inspections check if the procedure defined in the instructions leads to the intended objective, i.e., if the regulatory content and scope are described in a suitable and adequate manner (cf. figure 18.B-3). In light of the fact that the procedural instructions have already been subject to a technical review during their approval procedure, this control seems superfluous. However, in practice it has proven necessary, because process sequences are influenced by changes in the general operating conditions. Many small changes that are not recorded by the change control procedures can make it necessary to bring the procedure, once established, in line with the changed conditions.

Figure 18.B-3 Examples of procedure-based inspection topics

Examples of procedure-based inspection topics

  • Inward transfer and discharging staff from clean rooms
  • Sampling of raw materials
  • Manual cleaning of equipment
  • Transfer of rejected goods
  • Manual packaging of small batches
  • Initial weight of raw materials
  • Integrity tests of product-carrying sterile filters

On the other hand, procedure-based inspections should also show if the requirements defined in the procedural instructions are fulfilled in practice by the equipment and staff (compliance inspection). For example, the maintenance and calibration status of the equipment can mean that it is not possible to achieve or comply with the established parameters and thus the requirements are not met. If staff are given insufficient training on the procedural instructions, implementation problems can occur due to a lack of staff qualification. Internal organisation deficits and the work motivation of the staff can also lead to a procedure not being executed in the prescribed manner.

The practical experience of the staff is a valuable source of information for the continuous improvement of the procedure. The inspection should therefore be executed in close collaboration with the on-site staff concerned.

4 Area-based

The inspection of delimitable areas, such as the warehouse, the packaging department, the weighing centre or the changing rooms and wash rooms, offers the possibility of formulating the inspection plan so that the entire company is inspected within a defined period of time. In addition to the procedure-specific aspects, it is also possible to check the conditions for the area. figure 18.B-4 shows a selection of topics that can be taken into account in area-based inspections.

Figure 18.B-4 Topics for area-based inspections

Topics for area-based inspections

  • Hygiene status of the rooms and facilities
  • Status of floors, walls and ceilings
  • Labelling of material, equipment and pipes
  • Provision zones and material movements
  • Machine log books (calibration, maintenance, malfunctions)
  • Prevention of cross-contamination
  • Required instructions and on-site records
  • Responsibility regulations of the area
  • Clothing and conduct of the employees at their place of work
  • Staff training documents

Summary

The objective of the inspection determines the inspection procedure and the focus of the inspection. Topics for system-based, product-based, procedure-based and area-based inspections are presented.



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