Principle #9 - Building Quality Into Products By Systematically Controlling Components and Product Related Processes Such As Manufacturing, Packaging, and Labeling, Testing, Distribution, and Marketing

Those of you who work in the food, drug, cosmetic and medical device industries know that the health and safety of your customers depend on the quality of your products. It is very important, therefore, that you do your best to build quality into each product you produce.

Recognizing that product quality is so important to your customers, you need to ask yourself two key questions: 1) What is Quality? and 2) How Can We Build Quality Into Our Products? We can answer the first question by defining quality as the absence of defects - defects which are most often caused by contamination, mix-ups, and errors. Since the best way to prevent contamination, mix-ups, and errors is to follow the guidelines of Good Manufacturing Practice, let's see how GMP can help us answer the second question.

Well, through GMP we can identify four critical areas in our manufacturing
operation where you must establish effective controls to assure product quality.  There are key elements in each of these critical control areas that help you build quality into your products. Let's briefly examine them.

1.Control of Components. Check all of your components when they enter the plant to be sure they meet your purchasing specifications. All components must be tagged and stored in quarantine, sampled and tested according to your written procedures, and approved or rejected prior to release for manufacturing.

2.Control of the Manufacturing Process. Your company establishes records and procedures to assure product quality and uniformity. For each product you have master records that outline the specifications and manufacturing procedures, individual batch or history records to help you document your conformance to the master record, and written schedules and procedures for cleaning and maintaining your equipment.

3.Packaging and Labeling Controls. Since packaging and labeling are the areas where most mix-ups and errors occur, you must be sure to: assign a control number to each batch or lot to help you trace the manufacturing history of each product, inspect the packaging and labeling areas before each new batch or lot is processed (this helps assure that the area does not contain materials from a previous run), and follow your written procedures and carefully document your work.

4.Holding and Distribution Controls. Your company controls for any contamination, mix-up, or errors that might have occurred during the manufacturing process by quarantining and testing the finished product before it is approved for release, establishing written procedures for handling and storing your products, and keeping well documented distribution records to help you trace the shipment of your products should a complaint or problem arise.

Now that we have examined four critical areas of your manufacturing operation, let's look at the people responsible for controlling the quality in these areas. As you know, the Quality Assurance/Quality Control department samples, tests, approves or rejects all components, in process materials and finished products.  They also audit our compliance with GMP. But remember, QA/QC can only inspect for quality. Building in quality is the responsibility of everyone. That's right! Every person and every job in your company has a direct effect on the quality of your products. You must constantly control for quality by doing your jobs right the first time. When you use Good Manufacturing Practice as our guideline, you are building quality into your products.

So, do your part. Meet your personal responsibility to produce quality products.   Make GMP a part of your "lifestyle" today!