Everyone involved in the manufacturing and processing of FDA regulated products, has the responsibility to do their best to ensure that every product we manufacture is safe, and of the highest possible quality.
On a recent audit I participated in, for one of our customers, the auditor stated that the effort and success criteria small companies will have to meet on the way to their success in the “Validation” aspect, that will be enforced in the next 2-5 years. Who ever will adjust to this way of thinking soon enough, will find himself in better readiness in the future. In order to assure our safety, the FDA constantly inspects food, drug, medical device manufacturers, blood banks and other health care organizations, to determine quality manufacturing and control practices.
What is GMP
These control and practices are established in a government regulation called Good Manufacturing Practice regulations (GMP). The GMP regulation, establishes minimum standards, for the manufacturing of our products, to assist in preventing adulteration. But more importantly, GMP needs to be a so called “lifestyle” that each company clearly defines and implements through its quality systems, in order to protect the safety of its customers.
The 10 principles of the GMP
Lets focus on how the 10 principles of good manufacturing principles will help making GMP a lifestyle in our organization.
1) Writing step-by-step procedures and work instructions provides a road map for GMP compliance in controlled and in consistent compliance.
2) Carefully following written procedures and instruction to prevent contamination, mix-up and errors.
3) Promptly and accurately document our work for using Document Management System for better compliance and traceability .
4) Proving that our systems do what they are designed to do by validating our work.
5) Integrating productivity, product quality and employee safety into the design and construction of our facilities and equipment.
6) Properly maintaining our facilities and equipment.
7) Clearly defining and demonstrating job confidence.
8) Protecting our products against contamination, by making cleanliness and hygiene a daily habit.
9) Building quality into our product by systematically controlling our components and product related processes, such as manufacturing, packaging, labeling, testing, distribution and marketing.
10) Conducting planned and periodic audits for compliance and performance.
These 10 principles of GMP, provide us with a perfect framework for building and maintaining a GMP lifestyle, and help us evaluate how well we are complying with the standards of good manufacturing practices.
The first two GMP principles stress the importance of written procedures. The best way to comply with GMP, is to have well written procedures and to carefully follow them.
The heart of GMP is the establishment of well written procedures of each operation. These written procedures give us the controls necessary to minimize the chance of mix-ups and errors in manufacturing a product. When we carefully follow our written procedures, we not only ensure compliance with the GMP regulation, but more importantly, we ensure the consistent quality of our products.
Fig 1: Manage your procedures in QPack DMS™
The next two GMP principles, stress the need for us to document and validate our work. Because documentation and validation are so important to us and to our company, lets look at them more closely.
We may begin by asking, what does documentation really mean, in terms of our job performance? Well, documentation requires a specific action on our part. The recording of each significant step we perform as we perform a job task. Documentation should be made properly and accurately, and in accord with our written procedures.
As important as documentation is, it shows only that we have carefully and exactly followed our written procedures. Validation is proactive proof that we can produce safe and effective products. Validation requires a series of tests to assure that our systems and processes do what we say they do. We must be sure our production processes consistently meet the specifications our company has established. Therefore validation gives meaning to the documented records we keep. It is validation which tells us that our written procedures are correct, and that our products are truly safe and effective.
Fig 2: QPack Validation Electronic Report
GMP principles fifth and sixth focus on the design, construction and maintenance of our facilities and equipment. Lets take a look at how GMP relates to the place where we work, and the equipment we use.
Our key concern is to avoid the possibility of contamination, mix-up and errors in our workplace. For example, we keep certain areas, the cafeteria, locker room and washrooms, separated from the manufacturing area. Where necessary to protect the integrity of our products, we carefully control water, air, temperature and humidity. Housekeeping, sanitation and maintenance also work to defend against contamination, mixups and errors.
The seventh GMP principle states that good manufacturing practice requires competent people. People who can do the job right, the first time and every time. That means it is our personal responsibility to develop, demonstrate and continuously improve our job competence.
In order to do any job well, we must be properly trained; and this is particularly true in the manufacturing and quality control areas. In fact, our company must have a formal training program, to ensure that each employee can competently perform assigned job responsibilities. And that leads to our eighth GMP principle, which focuses on cleanliness, and requires us to be constantly on guard to defend our products against contamination.
Fig 3: Build your training program and control its execution
Contamination can be a powerful and dangerous enemy, which takes on many different forms. One of the most common forms is Particulate Contamination. This simply means that a product has been made impure by any particle that doesn’t belong in it. For example, dust, lint, fibres and hair are all potential causes of Particulate Contamination. That is why, we must be properly dressed to prevent contamination, when working with our materials, component and products.
The second kind of contamination is Microbial Contamination. This is caused by microscopic organisms, known as microbes. Microbes are living organisms that exists one everything in the environment that has not been sterilized. Microbes include fungus, mold, bacteria and viruses.
A third form of contamination is Cross Contamination. Cross Contamination occurs when traces of other materials’ components and products adulterate or mis-brand the products we are currently manufacturing, packaging or testing. So it is critical that we practice good personal hygiene, and help keep our workplace clean by reporting any condition or practice in our plant, or with our equipment that might be a potential source of Particulate, Microbial or Cross Contamination.
The ninth GMP principle, focused our attention on the importance of building quality into our products, by systematically controlling our components and product related processes. To see how GMP helps us build quality, lets examine the critical areas where we must establish effective controls. Materials and components present the first critical control challenge. We must be sure all of our components and materials satisfy our quality standards. Upon receipt, they must be carefully examined for damage and contamination, properly identified and tagged, and stored in a quarantine area. Where required, certain components and materials must be sampled and tested to ensure they meet established standards of identity, quality and purity. Only after approval are they released to manufacturing and used on a first-in first-out basis. That is, the first materials and components approved for release, are the first to go to manufacturing.
The second critical area we must control, is the manufacturing process itself. To ensure quality and uniformity of each product, we have master records that outline the specifications and manufacturing procedures, and individual batch or history records (E-DHR) to help us document our conformance to the master record, and written schedules and procedures for cleaning and maintaining our equipment. To help us operate in a state of control, we carefully follow written work instructions, accurately collect critical data, and promptly document manufacturing results.
Fig 4: Production ATE Results Online Collection using QPack OASIS™
Packaging and labeling is the third critical area where we control for quality. We must inspect the packaging and labeling area before each new batch or lot is processed; to help us be certain that the packaging equipment is clean and that the area does not contain any packaging or labeling materials from a previous run.
The fourth critical area is testing, and supports all other areas of control. How we handle incoming, inprocess and finished products test samples, how we perform test methods, how we document test results, are all significant elements of the testing process, and must be performed by qualified individuals.
Fig 5: Test Protocols Results using QPack Test Management™
The final critical area of control, focuses on how we assure the safety, effectiveness and purity of our product, as they enter the marketplace. The challenge to control the quality does not end when the finished product is tested and released. We must carefully control the product as we warehouse and distribute it to our customers. We must closely monitor the sales and marketing strategies we use to interact with our customers, and we must keep accurate records to provide product traceability, and promptly respond to any customer problems, concerns or complaints.
Fig 6: Follow Up Global Activity on Service Call using QPack Service Center
The tenth and final GMP principle, entails the need to continually audit our day-to-day job performance, and verify that we are in compliance with the GMP regulation. The FDA has a major responsibility to externally audit our manufacturing operations, to see if we are in compliance with the GMP regulation. But it is our company’s responsibility to internally ensure the integrity of our products. And most importantly, it is our personal responsibility to evaluate how well we are living up to the standards of GMP. By performing a self-audit, using the 10 principles of GMP, you can make GMP a daily lifestyle in our company, and not just a regulation.
Fig 7: Proactive Pre-Audit Reports/Alerts using QPack Reporting Tools
In addition to our responsibilities to our customers, the FDA also has a responsibility to protect the consumer. In fact, the FDA can recommend a recall, if they find one of our products contaminated, mislabeled or if our product is not manufactured in compliance with the current GMP regulation.
So it is extremely important that we carefully follow the 10 principles of GMP. At our company, we are all concerned about what we do, and how we do it. This concern for quality, helps us earn the trust of millions of people who use our products. It is our job to make GMP a lifestyle, and live the principles of GMP each and every day.