Manufacturing sterile injectables demands the highest product safety standards. And while a lot goes into maintaining product safety, one of the most critical aspects is robust employee training.
Even the slightest deviation of standards by an employee can lead to detrimental effects that put the end users’ health on the line, not to mention the money lost in production delays, recalled products, and a tarnished reputation.
In one instance, a firm producing a sterile protein product experienced a significant financial loss due to inadequate training. During a quality control review, it was discovered that a new operator had incorrectly performed a test to confirm a sterilizing filter’s integrity.
Unfortunately, the product had already passed through the faulty filter and could not be recovered. As a result, the firm had to bear the costly consequence of destroying products worth $1,000,000. This incident underscores the crucial role of training in avoiding catastrophic errors in manufacturing sterile injectables.
Contrarily, well-trained personnel adhere to standards, maintain the highest quality product safety measures, and leave less room for human errors. The result is products delivered on time, maintenance of product safety, and an overall successful company.
Today, many organizations have turned to contract manufacturers(CMOs) to handle sterile injectable manufacturing. Now, the burden lays on CMOs to provide comprehensive employee training to protect the integrity of manufactured products.
The Role of Training in Product Safety
Every team member must be on the same page to achieve product safety in manufacturing sterile injectables. Training is vital for several reasons, as shown below:
- Cultivate a culture of adherence to standards: Training specifies each team member’s standards, requirements, and responsibilities. In other words, it outlines who’s responsible for what, when, and how. Raising awareness about current Good Manufacturing Practices (cGMP) and other relevant protocols helps your organization consistently produce safe and high-quality products that meet regulatory expectations.
- Reduce human errors and mitigate risks: Well-trained personnel are better equipped to handle potential hazards and risks in the manufacturing process.
- Prepare better for emergencies and responses: “Anything that can go wrong will go wrong.” Even the most controlled manufacturing environments are not excused from Murphy’s law. There’s always a risk of something not working as it should. However, when you’ve trained employees on cGMP, they will have the knowledge and skills to respond swiftly and effectively to emergencies. In turn, this preparedness minimizes potential harm and helps maintain consumer trust.
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Key Elements of Training Programs for Manufacturing Sterile Injectables
There are two key areas to focus on regarding employee training programs.
Good Manufacturing Practices(GMP)
GMPs are quality control guidelines and principles that ensure the consistent production of safe, effective, and high-quality products in sterile manufacturing. According to the International Society for Pharmaceutical Engineering(ISPE), GMPs should help minimize errors, mixups, and contamination.
Under GMP, there are several practices that employees must be aware of at all times.
Proper facility and equipment handling: GMP outlines strict facility design, construction, and maintenance requirements. Specifically, all personnel must be trained to adhere to cleanliness and environmental controls to prevent cross-contamination and maintain product safety. Proficiency in equipment operation minimizes the risk of accidents, malfunctions, or deviations that could jeopardize product safety and integrity.
Quality assurance compliance: Quality assurance is another key aspect to cover in training. Employees must be trained to follow and implement a rigorous quality assurance system for each step in manufacturing. In addition, relevant employees must have the skills to identify, assess, and mitigate quality risks.
Validation and qualification: Employees must also receive training for the validation and qualification of equipment, processes, and systems. This allows CMOs to produce the right level of desired product quality consistently.
Documentation and record keeping: To promote product safety, organizations must also train employees on accurate and comprehensive documentation of test data, batch records, etc.
All personnel must receive proper training to execute processes correctly. Organizations must also raise awareness about the essence of following GMP guidelines.
A facility’s standard operating procedures (SOPs) should be clearly communicated. These SOPs should be reiterated regularly in writing to ensure GMP compliance. FDA CFR 211.113(b) states, “Appropriate written procedures, designed to prevent microbiological contamination of drug products purporting to be sterile, shall be established and followed. Such procedures shall include validation of any sterilization process.”
Training on Aseptic Techniques and Cleanroom Behavior
Cleanrooms are controlled environments designed to minimize contamination during sterile manufacturing. Employees should be instructed on clean room aseptic techniques, gowning procedures, and properly using PPE.
Below are the most vital topics to touch on during training:
- Environmental monitoring
- Routine disinfection
- Critical utilities
- Sterilization processes
- Problem-solving and troubleshooting
- Best industry practices for injectable manufacturing
What Is the Importance of Competency Development in Product Safety?
Competency-based training (CBT) focuses on developing specific skills, knowledge, and behaviors required to produce quality, safe injectable products. Instead of solely focusing on theoretical knowledge, CBT emphasizes practical application and demonstration of competencies.
For organizations in injectable manufacturing, competency development starts with building a culture of quality and safety. This can be achieved by doing the following:
- Develop clear quality policies aligned with product safety goals and objectives.
- Establish a robust quality management system that includes all aspects of aseptic techniques, cleanroom protocols, GMP guidelines, equipment operation, batch record documentation, and deviation handling.
- Incorporate practical hands-on training sessions in sterile environments to allow employees to apply theoretical knowledge to real-life scenarios.
- Encourage employees to report any potential quality or safety issues. This can be done through various methods, such as anonymous reporting hotlines or open-door policies.
- Monitor the effectiveness of the quality management system continuously and make changes as needed.
- Implement ongoing training and refresher courses to keep employees up-to-date with industry standards, technological advancements, and regulatory changes on sterile injectables.
4 Examples of Training Programs Offered by CMOs
CMOs, at least those aiming for a culture of product safety, cover several fronts when training their employees. Below is an overview:
- Practical and hands-on experience: CMOs usually take employees through practical and hands-on lessons on handling materials, containers, and products for sterile injectables. For instance, employees may be engaged in drills on proper gowning when handling different manufacturing stages.
- Simulation: These exercises enable CMOs to test employees’ skills in an aseptic environment. For example, you can create a controlled environment with a mock aseptic filling line and several contaminated vials to evaluate how employees would handle the product safety risk.
- On-the-job mentoring: CMOs pair employees with experienced mentors to guide them on core competencies and quality assurance policies. This way, the organization achieves better knowledge transfer and personalized training and feedback for employees in training.
- Continuous education and professional development: CMOs also engage employees in conferences, seminars, workshops, and certifications to ensure they know the latest industry advancements and regulatory changes.
How Can CMOs and Pharmaceutical Companies Collaborate on Employee Training for Manufacturing Sterile Injectables?
Pharmaceutical companies often turn to CMOs for sterile injectable manufacturing. Therefore, the success of CMOs, including the performance of their personnel, is a huge benefit for their clients.
Pharmas can work with CMOs to promote employee training. The pharmaceuticals are assured they are working with a CMO with similar and expected quality assurance measures. Here’s how the two can collaborate.
- Training program development and implementation: CMOs and pharmaceuticals can work together to create training programs that cover their product safety expectations.
- Cross-functional training opportunities and knowledge exchange: The two parties can also collaborate on workshops and conferences to equip employees with the latest standards and advancements in injectable manufacturing.
- Establishing clear training expectations and goals: The two organizations can outline training expectations and goals that must be met to achieve product safety. This will help harmonize employee training and promote successful and on-time delivery of injectable products.
Continuous Improvement and Ongoing Training Evaluation
Employee training in sterile manufacturing is not a set-and-forget action. Instead, CMOs are required to continuously train and evaluate their employees to guarantee continued product safety.
At the start of training, a set of key performance indicators (KPIs) will enable CMOs to measure training effectiveness. It will also help identify training areas that require improvement.
CMOs can also rely on regular assessments and surveys to gather feedback on training from relevant employees. In addition, CMOs must maintain meticulous records on the progress of training. This data will be needed during FDA inspection. However, the data will also be vital for improving the training programs.
Future Trends in Sterile Manufacturing Training and Competency Development
Conventionally, employee training happened via ‘encyclopedia-like’ manuals that were hard to follow, let alone remember. However, technology has made employee training more effective and simple to follow. These are the future trends for sterile manufacturing employee training and competency development.
1. Virtual and Augmented Reality(VR/AR) Training Solutions
CMOs will increase the use of VR/AR technology to deliver training. For instance, organizations may use VR simulations for aseptic filling practice or AR overlays to guide technicians during equipment operation.
2. Integration of Digital Platforms for Remote Training and Knowledge Sharing
CMOs will also turn to technologies such as AI to deliver real-time support to employees during training. For instance, employees can use AI-supported chatbots to get answers about the latest FDA regulations on cleanrooms quickly.
In another example, employees can access training resources 24/7 via mobile apps.
3. Gamification and Interactive Learning Techniques
Training resources will include gamified and interactive videos, images, and assessments to increase engagement to evaluate employee skills. These techniques will also improve retention rates of information provided.
Final Thoughts
Robust employee training and competency development in sterile manufacturing cultivates a culture of adherence to product safety standards, reduces human errors, and prepares personnel for emergencies.
For more information about sterile injectable manufacturing, visit the Afton Scientific website.