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GMP LOGFILE Features

2017-02-15

LOGFILE No. 06/2017 – Awareness for GMP Compliance

How do you create awareness for GMP compliance in a ­company?

An excerpt from the GMP MANUAL, Chapter 18.I.4.1

(3 min. reading time)

by Thomas Peither

 

Quality systems create a framework for GMP-compliant work in a manufacturing environment. The actual implementation, however, normally depends on staff. The communication between systems and members of staff is often decisive.

To illustrate this point, it is possible to compare a pharmaceutical company with a human being.

  • The bone structure, i.e. the hardware, is the basic frame for the systems and subsystems, such as buildings, machines, rooms and computers .
  • The muscle cells that produce movement are the company employees. They keep everything in motion.
  • The nervous system is the world of computers including the wiring of the individual hardware components and the software. Sensory perceptions are to a certain extent directly processed here without having to think about it.
  • The different organs are quality elements, manufacturing processes and expert functions.
  • The brain corresponds to leadership and organisation. Its function is to identify connections, influencing factors, deficits, etc. Another function is the support and optimisation of the interaction within the overall organism.

If we look at a pharmaceutical manufacturer in this way, the GMP inspector wants to find out whether the organism is healthy or ill. Does the company act in a consistent way and in accordance with the GMP requirements? To answer this question, the entire organism is looked at, but some organs have to undergo more extensive testing.

What is the meaning of the further training of personnel in this context? The DNA of each body cell contains the blueprint for the entire body. Despite this, each cell has its own function. Each employee should be aware of the company's complexity, but at the same time recognise their own responsibility and tasks. The thyroid gland produces the hormones triiodothyronine and thyroxine, both of which contain iodine, as well as the peptide hormone, calcitonin. When healthy, the cells of the thyroid gland are aware of this and can fulfil their function. However, if the thyroid gland does not receive enough iodine, long-term metabolitic problems occur.

The same applies, for example, with deviation management. When a company is "healthy", deviations are recognised, processed and reduced. If a company is "ill", backlogs occur and the normal workflow is negatively affected.

Each employee must know their job and carry it out to the best of their ability. The training/qualification of employees is therefore important for creating awareness in a company – before GMP inspections at the latest.

Many things are forgotten during routine operation. All employees should therefore receive an update on a regular basis. "How far have we got with our preparations for the FDA inspection?" This question does not only concern those in the company who are directly entrusted with the preparations. The following options can be used to keep members of staff informed:

  • Regular newsletters for all employees
  • Project website in the company Intranet
  • Voluntary training events, e. g. during lunch with snacks
  • Information during staff meetings
  • Articles in company magazines
  • Department information

The author has had positive experiences with these options. They can be used to increase GMP awareness significantly throughout the company. The staff members know what's happening and can therefore contribute to the achievement of the objectives.

This text is an excerpt from the GMP MANUAL, Chapter 18.I.4.1

Author:

Thomas Peither
Maas & Peither AG - GMP Publishing
E-Mail: thomas.peither@gmp-publishing.com
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