GMP in the production process

Here you will find answers to the following questions:

  • What quality assurance elements are included in production?
  • What aspects must be taken into account to establish GMP in production?

The manufacturing of specification-compliant products depends on the existence of various quality assurance elements. The quality of the individual elements determines the probability with which manufacturing will be carried out without problems, i.e. within the prescribed limits. Reproducible production is only feasible given these limits and their mutual interaction. It is the task of the quality assurance system to guarantee this constellation (see figure 11.F-1).

Figure 11.F-1 Quality assurance elements for pharmaceutical manufacturing

Link to 11.F-1.jpg

Ideally, quality control of the final product would not be necessary if correct manufacturing could be guaranteed by the environment. However, due to the many different influencing factors, this only applies in theory. Furthermore, the legislator prescribes final product quality control for pharmaceutical products. The care with which the surrounding and preliminary influencing factors are managed is responsible for the effort that must be made in the actual production.

In addition to the elements listed, the aspects shown in figure 11.F-2 also represent important values for GMP-compliant production.

Figure 11.F-2 GMP aspects in the production process

GMP aspects in the production process

  • Evaluation of the process parameterisation
    (regular product review)
  • Evaluation of the raw material specifications
    (restriction of specification limits)
  • Traceability of processes, primary and secondary documentation
    (identifiable via defined code numbers (batch) assignment system)
  • Practicality of the manufacturing instructions
    (evaluation of comprehensibility, completeness)
  • Congruence and practicality of the procedural instructions
    (agreement and practical executability of the requirements)
  • Qualification level of the staff
  • Process capability of machines, equipment and processes
    (qualified machines and equipment and validation of processes and process changes, maintenance, repair, calibration)
  • Product handling
    (definition of in-plant handling of products (residence times of intermediate products, take of, distribution)

Self-inspections are an important way of guaranteeing the GMP status within the plant, in this case production. These inspections help uncover deficiencies and highlight possibilities for optimisation. A permanent TARGET/ACTUAL comparison of requirements of the quality assurance system and its practical implementation helps improve the status. The inspections should be considered as an opportunity to promote the GMP-specific development process. (See chapter 18.E Self-inspection.)


Different quality assurance elements help create a GMP environment in which specification-compliant products can be manufactured. In addition to the GMP-compliant environment (rooms and facilities), this also includes controlled processes, trained staff and a dense network of instructions and records.