Principle #5 - Integrating Productivity, Product Quality, and Employee Safety Into the Design and Construction of Facilities and Equipment

Good Manufacturing Practice is a goal common to every food, drug, medical device and cosmetic manufacturer. The responsibility for achieving this important goal and making GMP a "productive lifestyle," not just a regulation is shared by many people in many different ways. For example, one of your personal GMP responsibilities is to carefully follow your written procedures. Another is to promptly and accurately document your work. And a third way to "stay on target" in meeting your GMP responsibility is to properly maintain your facilities and equipment. This third GMP responsibility is very important to company productivity, employee safety and product quality.

So let's examine how the proper maintenance of our workplace relates to Good Manufacturing Practice. The proper application of GMP to the workplace involves many different factors. If your company is to be productive, if you are to work in a safe environment, and if you are to manufacture quality products, you must keep four key points in mind.

1. Provide Adequate Space - A lack of space in our manufacturing area can cause confusion in the work flow, and this could possibly have an adverse effect on company productivity. A lack of space can also cause unnecessary traffic in the work area which can endanger employee safety. And finally, a lack of space could affect your product quality by causing cross contamination of product components or mixups and errors in labeling and recordkeeping. So, as you can see, it is important to maintain adequate space in your manufacturing area.
2. Control Internal Environment - Another important area that you must constantly maintain is your internal environment. By internal environment we mean the air, water, lighting, ventilation, temperature and humidity in our plant. Your company develops written procedures and standards to ensure the proper maintenance and control of your internal environment. The plant sanitation program is one example of the "built in" controls you use to minimize the chance of contamination, mixups or errors in your manufacturing area. It is very important that everyone knows and understands his/her personal responsibility in complying with plant sanitation standards.
3. Inspect and Maintain Equipment - The routine inspection and maintenance of your equipment is another important factor in applying GMP to the workplace. The proper maintenance of your equipment requires that you frequently check certain indicators to make sure all equipment is operating properly. Similar to the operator's manual for a car, the written procedures tell you when and how to inspect indicators and maintain equipment. They also tell you what type of lubricants, coolants and cleaning agents to use when operating or cleaning equipment.
4. Keep Accurate Records - Just as the conscientious car owner keeps a record of the mileage between tune-ups, the date of the last oil change, and when the tires need to be rotated, Good Manufacturing Practice requires that you keep accurate records concerning each piece of major equipment. Your "equipment logs" tell you such important information as: when the equipment was used, what it was used for, when it was cleaned, inspected or repaired, and who do it and how it was done. This important information helps you control the proper use and maintenance of our equipment and helps us prevent contamination, mixups, and errors.

Yes, GMP is a goal common to every food, drug, medical device and cosmetic manufacturer, and the responsibility for achieving this important goal and making GMP a "productive lifestyle," not just a regulation is shared by everyone. One of your most important GMP responsibilities is to properly maintain your facilities and equipment. You can help meet this important GMP responsibility by focusing on four key points:

1. Provide adequate space in the workplace.
2. Control the internal environment.
3. Routinely inspect and maintain equipment.
4. Keep accurate records.

Remember, when you properly maintain your workplace you are helping to assure company productivity, employee safety and product quality.