Friday, 1 May 2015

EU GMP - Personnel Hygiene or Personal Hygiene?

It is a matter of perspective!

Personnel is is inwards; about the self! Personnel is outward; about someone else.

When you point a finger outward, just turn the wrist 180 degrees and you will see three fingers pointing back at you. So all those who are in managerial positions and who conduct training programs need to look inward about their personal hygiene before they teach personnel hygiene.

We conceive and deliver what and who we are. A human delivers a human being just as any other species delivers its own kind. By the same law, a clean person will deliver a clean system and a clean environment for the manufacture of a clean drug product.

Again, a human being is not a machine to be switched on or off. An unclean person at home cannot be switched on to be clean at his place of work. Clean habits begin at home and get transferred to the place of work.

In the light of the above, it is imperative that the focus shift from personnel hygiene to personal hygiene. If the person becomes neat, clean and orderly, then it is relatively easy to train and cultivate a neat, clean and orderly workforce.

Moreover, a human being is a creature of habits. Habits are formed by the repetition of actions over a considerable period of time. This requires discipline and monitoring. This technique can also erase old bad habits and cultivate new good habits.

What exactly is personal hygiene?

Besides looking and smelling good, personal hygiene is about prevention of diseases and maintaining good health over the life span.

We begin our day by brushing our teeth. Are we consistent with our brushing? Do we do the actions of brushing in a carefully designed and defined manner? Do we reach all corners of the mouth and access all teeth? Do we favour a particular side while brushing? Do we clean our tongue? 

Importantly, are we conscious of brushing while brushing? Many of us brush our teeth while thinking of something else. Sometimes we are in such a hurry that brushing is cursorily done. The fad of multitasking has also led us to be thinking of something else while our hands are engaged in an entirely unrelated activity.

Do we plan our oral hygiene program? Is there a dentist visit included in our program? Do we use dental floss or mouth rinses? How often do we rinse our mouth? Do we do so after each meal? The modern world influenced by different cultures seems to be shunning the old habit of rinsing the mouth. It is considered cool to be able to use a tissue 'appropriately' to wipe the mouth and it is a matter of etiquette how adept you are at using the finger bowl. But these do nothing for your oral hygiene.

Bad breath is usually associated with bad oral hygiene. Bad breath can happen with food particles lodged and decaying in the mouth especially teeth. While it may be true to an extent, bad breath usually comes from deep within your food passages. It reflects poor food habits and bowel movement and when air from the respiratory system accompanies the odour from the gastric system, it is termed as bad breath. Consumption of onion and garlic is a good example of breath coming from within the gastric system. 

One can really run an intensive and elaborate training program about brushing teeth.and oral hygiene because the mouth is a huge source of microorganisms and a human being is the largest contributor to the microbial load in a pharmaceutical manufacturing environment. The quantum of bioburden can be reduced significantly if the workforce is especially trained in oral hygiene.

The other area of personal hygiene is the skin and this brings us to the issue of bath, hand wash and toilet practices. The human body has its fair quota of crevices. These are areas of moisture retention and microbial growth. These are also areas of skin irritation and itching which leads the hands naturally to those areas for scratching. Quite obviously the microbial load gets transferred to the fingers and this then gets transferred to the products. 

Having a clean bath is a skill that has to be deliberately acquired by repeated and good bathing practices. Many of us who are hard pressed in the morning due to the time crunch and experiences of delay usually compromise on personal hygiene practices by 'rushing' through the morning processes. 

At the place of work, hand washing stations are not available like trash cans or spittoons all over the campus. Only in the process of change rooms does a person has an opportunity of washing or disinfecting hands. Herein lies the difficulty! It is largely up to the individual to wash or disinfect his hands based on the Standard Operating Procedures displayed in words and picture forms in the change rooms. The personal habits of people come into play. Some do it, some don't and some do it in such a way that it would make good starting material for a stand-up comedian.

The feet are the biggest carriers of contamination. Shoe covers and booties are actually an eye wash. They look good! When a foot falls on a shoe cover the pressure of the weight of the individual squeezes micro particles through the fabric of the shoe cover. The cleanliness of the foot is again a matter pf personal hygiene. Habits at home come to work. If a person is accustomed to reaching home, tired and in low spirits and simply plonks on the chair or sofa after discarding his footwear, he will carry that same mentality to his place of work. Attention to the cleanliness of feet is a distant matter. To think about it, the foot is at the furthest distance from our thinking apparatus, the brain.

Then there is this small matter of fingernails and the gap under them. Great assembly halls for microbes to have a ball. Literally! Cutting nails is another personal hygiene issue cultivated by practice. Also a trifle difficult subject when it comes to ladies as fingernails is a fashion statement. Then there is the other aspect of nail polish and artificial nails.

The ears, nose, hair, armpits, pelvic area are other areas for care and personal hygiene with particular attention.

It is actually a subject for R&D if it can formulate a program to find out "what" type of contamination comes from "which" part of the body and "when" is the load at its peak and "how" to address this contamination. All GMP guidelines acknowledge the human element as the biggest source of contamination and it is indeed ironical that a minimal effort goes into the aspect of personal hygiene. 

By calling it Personnel Hygiene, the subject is transferred to HR Department and unfortunately the HR is least qualified technically to address this issue and the technical departments are least interested because it is a matter related to HR. Net result: Hygiene continues to languish at the bottom of the attention radar and a lot of focus and effort is on cleaning and cleaning validation.

One day the focus will hopefully shift to the human factor and due importance will be given to "Personal Hygiene".

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