If you are wondering about the importance of Good Manufacturing Practices and why it is necessary to get certified in GMP within the pharmaceutical industry, you have your answer right there. In April of 1969, the federal government approved the finalized document which then became part of the Code of Federal Regulations.
It was published as Part 128 of the CFR and has been thus regulated ever since. In short, that’s why it is important. It’s important because pharmaceutical manufacturers must adhere to the regulations set forth within the document. However, the reason for creating those regulations is even more important. In short, Good Manufacturing Practices are the backbone of the industry with one objective overall. That would be the safety of consumers as is the bottom line of everything the Food and Drug Administration oversees.
What Are Good Manufacturing Practices? Â Â
With the purpose of Good Manufacturing Practices being to avoid mistakes in order to ensure the safety of consumers, the regulations have been broken down into five subsets. These include:
- Primary Products and Materials
- Premises
- People
- Procedures
- Processes
In order to become GMP certified, all five of those categories must be studied extensively and the individual must pass a proctored exam. However, not all people employed within the industry need be certified.
Who Should Be GMP Certified?
It is usually one or a few people employed by a pharmaceutical laboratory that must be certified. That is not to say that others cannot or should not take the course, it only means that certification is reserved for such professionals as the:
- Managing director
- Quality assurance manager
- Quality control manager
- Production manager
One or all of those professionals may be certified as is their right within their roles with the company. In fact, more than one person in a vital position within the company getting certified tends to lend credence to the company’s moral character.
A Closer Look at Those Five Objectives
The course is structured in such a way as to provide a fundamental understanding of the regulations. They will learn why it is necessary to implement these core principles and how to apply them within laboratory settings, manufacturing processes and even within support functions. The course is designed in such a way as to demonstrate why there is a need for regulations and how to document each of the regulations involved.
Participants will also learn specific terminology within Good Manufacturing Practices as it is used within the parameters of the implementation of each set of regulations. The entire focus is compliance because the regulations were established to ensure the safety of every product that is released for use by the general public.
Globalization of GMP Regulations
There is another very important function within the set of GMP guidelines and that is to ensure the safety of any country or entity to which products manufactured in the United States would be exported to. Conversely, the United States also seeks to ensure that any products manufactured abroad and imported into the United States should conform to global GMP regulations as well.
Central Objectives of GMP Coursework
To sum it up, there are a few central objectives within the framework of the GMP certification course and those are set forth quite specifically. These objectives are:
- To understand GMP concepts within the decision-making role of management
- Better understanding of equipment and facility design and how they impact the final production of product
- To understand the difference between validation and qualification within commissioning
- To become expert in risk assessment and management
- To become familiar with how to locate regulatory information as it is needs
Here again, although anyone ‘can’ take courses within the GMP framework, it is regulated that at least one manager within the company has studied for and passed GMP certification.
Fees Associated with the Course
The fees for taking GMP certification courses can be a bit stiff which is why it is suggested that companies pay the cost or at least meet the applicant halfway. Since regulations mandate that every company involved in the manufacturing of pharmaceuticals be GMP certified, it really is within the best interest of the company to pick up the tab, so to speak.
Bear in mind that part of the entry requirements is that participants be actively working in the field with experience in one or more areas of the course framework. With that in mind, it makes good sense for the employer to cover all costs involved. Employees in managerial positions have earned the right to be compensated for their efforts and as loyal employees and salaried staff; they are the ones with a solid background deserving of recognition for their efforts that have led to many successes on a company-wide level. GMP certification isn’t for everyone, but for those who can (and must) benefit from being certified, now is the time to pursue the culmination of goals set into motion that first day on the job.
