Pharmaceutical quality is important to all Americans; consumers deserve medicine that is safe and effective. This is why the Food and Drug Administration (FDA) regulates the production of pharmaceuticals very carefully. They not only test the final product before it goes to market, but also have strict requirements for the manufacturing, processing, and packing of a drug product. These regulations are known as Good Manufacturing Practices (GMP).
GMPs ensure a product is safe for use and that it contains the ingredients it claims to have. They also lay out strict guidelines for training employees involved in any aspect of production. Companies that fail to integrate GMP training into their employee onboarding process may be hit with fines from the FDA or, worse, create a product that harms consumers.
Here, we’ll discuss how to integrate and optimize GMP training into your onboarding processes. That way, your workforce will be informed and prepared to produce the medicine Americans rely on.
- What is GMP?
- Why is GMP important?
- Who needs GMP training?
- Why is training necessary?
- What topics should training cover?
- What are common mistakes in CGMP onboarding?
- Where is there more information?
What is the Good Manufacturing Practices definition? GMPs are regulations that cover all aspects of production; from the starting materials, premises, and equipment to the training and hygiene of staff. Pharmaceutical companies may also need proof that they are adhering to these standards at each step in the manufacturing process every time a product is made.
Many countries have their own national or regional Good Manufacturing Practices (GMP), adapted from the World Health Organization’s (WHO) standards. In the U.S., Current Good Manufacturing Practices (CGMPs) are established by Article Twenty-one of the Code of Federal Regulations.
It is important to note that CGMPs are minimum requirements. Many pharmaceutical companies will have already implemented comprehensive quality control systems that go beyond these standards. Further, the regulations established by CGMPs are flexible, allowing manufacturers to implement individualized control processes that support innovation.
CGMPs are important for three reasons. Firstly, they ensure the safety and efficacy of pharmaceutical products sold in the U.S. Poor quality medicines are not only hazardous but a waste of money for both governments and individuals.
Second, because the FDA’s requirements differ from the GMPs of the EU and other countries, drugs synthesized without FDA certification cannot be sold in the U.S. Following CGMPs is the only way a pharmaceutical company can tap into the U.S. market.
Finally, failure to comply with CGMPs can cost a pharmaceutical company millions of dollars under a Consent Decree levied by the FDA. Further, noncompliance is sure to generate bad publicity and reduce consumer confidence in the company’s products.
U.S. CGMP states that all individuals involved in pharmaceutical production must receive training on the regulations on an initial and ongoing basis. In short, that means long-, short-, and medium-term employees, new hires, and intracompany transfers need training. From 21 CFR 211.25(a):
Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations…) as they relate to the employee’s functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
It is important to note that employees need training not just in CGMP basics, but need specific training in how the CGMP regulations affect their specific role. The FDA outlines the requirements for different production roles on their website. Generally, employers will need to cover hygienic practices, record-keeping, and materials and handling processes. Additionally, while initial training must be a part of onboarding, employee’s should receive refresher courses regularly, as processes evolve.
Failure to comply with Pharmaceutical good manufacturing practices training doesn’t just make your product unsafe— it can also lead to serious problems with the government. Many companies have received a Form 483 from the FDA regarding non-compliant training. If this noncompliance is not addressed, the FDA can place the company under Consent Decree, potentially costing the business millions of dollars as well as its reputation. Some commonly cited violations include:
- Insufficient GMP training for employees
- Failure to establish written responsibilities and procedures for production and process controls, quality control units, stability testing, equipment cleaning, and maintenance, etc.
- Use of invalid laboratory controls
- Deviations related to equipment maintenance, calibration, and qualification
- Lack of documentation of CGMP activities
CGMP onboarding must prepare pharmaceutical employees to work in a GMP environment. Training should thus cover both the basic elements of this environment and how CGMP regulations relate to the specific position. For example, they should include:
- The importance of regulation and what the regulations require
- An overview of the product development and production process and how the employee’s role supports the process
- Expectations regarding procedures, training, documentation, and data integrity
- How to react when things don’t go as planned
- Standards for preparing processes and equipment
- The employee’s personal responsibility in controlling contamination
- Regulatory audits and expectations of personnel in these situations
- Basic information about CGMP enforcement including the impact of compliance failures
Employees should refresh their training regularly. This is not just to reinforce old information. Rather, it is because processes in the pharmaceutical industry develop quickly and employees need regular updates in order to apply standards to new procedures.
Implementing CGMP training is vital for the production of safe drug products. However, many businesses go about CGMP training in the wrong way. Here are three common pitfalls to watch out for.
- Companies don’t believe CGMP training can provide results. If your training only covers the bare minimum in the driest way possible, you are missing out on an important opportunity. The FDA requires this training because it is effective. It helps to keep employees up to date and conscious of the standards they are responsible for upholding. Prioritize employee engagement by asking employees to discuss the ideas and themes in small groups. It is important to invest in your training processes to make them interesting and thorough.
- Businesses use the same material over and over. Employees need individualized resources. Don’t show them the same video over and over again. Instead, use engaging materials in training modules and refreshers to make sure employees are really learning. Create an onboarding workflow so that employees can move through materials on their own and revisit information as needed.
- Training doesn’t connect the employee’s role to the regulations. It says it right there in the law: you must train employees to understand how the CGMP relates to them. Instead of using broad statements, explain the exact steps an employee can take within their specific role to ensure safety and quality. Use our employee onboarding checklist to make sure you’re covering all the relevant information.
Are you looking for more information on Good Manufacturing Practices (GMP) training? Then make sure to check out the following resources: