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GMP LOGFILE Features

2017-11-29

LOGFILE No. 45/2017 – 8 Golden Rules for Personnel Hygiene

8 Golden Rules for Personnel Hygiene

An excerpt from the GMP Compliance Adviser, Chapter 11.B.5

4 minutes reading time

by Christian Gausepohl, PhD

 

There are a number of golden rules that contribute positively to effectiveness in the area of personnel hygiene (see Figure 11.B-44).

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1. Implement the requirements in detail!

Even slight deviations from the requirements, during transfer for example, can have a significant impact, e. g. through contamination of clothing. A clothing system can only do its job properly when it is used correctly and nothing is omitted. The following questions should be asked:

  • Are the requirements described in enough detail?
  • Are they described clearly or could something be done to facilitate better understanding (e. g. illustrations)?
  • How is the content presented during training?

Practical examples from routine operation should be used for hygiene training courses so that the significance of strict compliance is highlighted. Feedback about problems must be taken seriously and checked.

2. Control yourself and others!

A simple example of self-control is the use of mirrors when checking clothing after gowning. Visual control by another person is just as important. In this way, problems can be addressed during transfer or during the procedure, e. g. if clothing slips or is contaminated or damaged. It is important that the significance of these controls is discussed during training so that the negative feeling of being watched is overcome.

The responsibility of supervisors is very important here because if there is no feedback, incorrect behaviour can quickly become the norm.

3. Everyone is responsible!

During hygiene training, the potential effect of each individual member of staff on the quality of the medicinal product must be explained. This does not only apply to those directly involved in the manufacturing process, it also includes personnel responsible for cleaning, maintenance, etc.

4. The rules apply to everyone!

Strict compliance applies to all staff, regardless of their position in the company. Managers must observe the requirements in the same way as persons in other functions, e. g. maintenance technicians. The importance of role models cannot be overemphasised.

5. Proper hygiene training is important!

Poor hygiene training sessions are boring and tend to repeat the same old materials in the same old way. For this reason, preparation, updating and the qualifications of the trainer are important. The aim is to get the course participants thinking and remotivate them.

6. Take observations and problems seriously!

Every type of observation is important. They can be discussed during training courses, e. g. in the form of feedback on problems from the course participants (example: glasses fogging up when a new type of face mask is worn). An atmosphere that facilitates open discussion is helpful and puts the trainer in a position of special responsibility. The observations and comments of personnel should also be taken seriously outside training sessions, and should be encouraged by regularly asking questions, e. g. about poorly fitting clean room coveralls. In this way, problems can be identified and prevented before they even occur. This is supported by an open culture of failure.

7. Report potential problems in good time!

Every member of staff is required to report not only existing problems, but also problems that may occur in the future. These can include difficulties with descriptions in SOPs or anomalies during operation.

8. Feedback is important!

Regular feedback improves understanding of the hygiene requirements and increases motivation.

 

This text is an excerpt of the GMP Compliance Adviser, Chapter 11.B.5

Author

Christian Gausepohl, PhD
Rottendorf Pharma GmbH, Ennigerloh

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