Quality is essential in the pharmaceutical industry and is not optional; rather it is required. Everything that is created or manufactured to become the final product, including tablets, capsules and vials, must meet current Good Manufacturing Practices (cGMP) to guarantee the product’s safety, effectiveness and reliability. However, even with the most complex systems or equipment, poorly trained personnel cannot provide compliance with these regulations.
Therefore, cGMP training is the foundation of any pharmaceutical organization that aims to be compliant. Organizations that are regulated by the Food and Drug Administration (FDA), World Health Organization (WHO) and European Medicines Agency (EMA) all state that there must be an established training program that adequately trains employees around understanding their role within an organization, as well as how an employee’s action may impact the quality of pharmaceutical products.
This article will provide information regarding how to administer an effective, compliant and interesting cGMP training program to your employees, from planning, delivering and evaluating the program to continually improving upon the program over time.
FDA CFR 211.25(a): "Everyone involved in manufacturing, processing, packing or storing a drug product must have the education, training and experience to perform the functions assigned to them."
EU GMP 2.9: "Employees are to have an understanding of the principles of GMP which apply to them with regard to both initial and continued training."
WHO GMP (Annex 2): Suggests documented and regularly conducted training programs according to the job responsibilities of the employee.
Training must be relevant to the individual (according to the requirements of that individual), documented, complete and ongoing - training is not a one-time event.
To create successful and effective cGMP training the following are essential steps:
The methodology used to assess the training needs include:
- Review of job descriptions and SOP responsibilities.
- Interviews and/or surveys of current knowledge.
- Using incident reports, CAPAs and audit issues/reports to identify continuing issues.
Develop and make training relevant to each department whether production, QA, maintenance and warehouse operation.
There are four important components to include in a training plan:
1. Training objectives.
2. Schedule of refreshers and training sessions at initial employment, scheduled periodic refresher training or scheduled change control based training.
3. Training delivery methods; classroom, e-learning, practical demonstration and hands-on and workshops.
4. Assigned Trainer.
5. Documentation of evaluation method; written tests, practical testing and observational checklists.
Each comprehensive training plan should align with a company’s quality system and regulatory requirements.
Training for New Employees (induction training):
– Overview of GMPs.
– Overview of company policies, company organization and quality system.
– Overview of health/hygiene/safety policies.
– Overview of documentation/data integrity principles.
Training for Existing Employees (role/position-specific training):
– Overview of SOPs (standard operating procedures) for your area/department.
– Overview of operating your equipment (operational use, calibration, cleaning).
– Overview of good documentation practices.
– Overview of how to document/manage deviations/change controls/corrective and preventative actions.
– Overview of product-specific training for manufacture and QC personnel.
Training for Management-level Employees:
– Overview of the development of risk management plan and implementation of a QMS.
– Overview of how to prepare for and conduct internal audits.
– Overview of how to prepare for and conduct a successful FDA inspection.
– Overview of root cause analysis/practice/continuous improvement practices.
Pro Tip: Make the training interactive and use photographs, case studies and actual examples from your own operations to keep the information fresh in people’s minds.
The types of training used:
Classroom Training: Most effective for learning about theories and group interactions.
Hands-on Training: Most effective for training on equipment operation, aseptic techniques or laboratory procedures.
E-learning: Provides a flexible learning structure and includes quizzes and video training.
Mock Auditing & Simulation: Prepares employees for real-life inspecting scenarios and demonstrates where training gaps exist.
On-the-Job Training: Using a supervisor or qualified trainer to demonstrate job performance is best for learning given the real-life working environment.
For Example:
Utilizing both classroom-based training, along with practical-based training can be the best way to provide maximum effectiveness in providing employee training.
Criteria used to select a suitable trainer includes:
Best Practices
Assessing the effectiveness of training can be accomplished through the following methods:
1. Knowledge checks - utilizing written and/or online quizzes after each training session.
2. Practical evaluation - through observation of the individual technician's performance during performing the respective task and/or mock inspections.
3. Feedback forms - the technician should provide input in the form of an evaluation form, to assist in the refinement of future training sessions.
4. Trend Analysis - review of the number of deviations/errors, prior and post training sessions.
If the participant does not pass the evaluation or repeatedly makes the same errors after the completion of training, they must be trained again or coached.
Documentation of all training events must be accessible at the time of inspection.
Essential documentation includes:
- Training Attendance Sheets with Original Signatures.
- Copies of Training Materials/PowerPoints
- Test Results and/or Evaluation Forms
- Trainer Qualification Files
- Training Summary Reports
It is recommended that you use a TMS or LMS to automate the scheduling and tracking of training and your records.
Re-training should occur when;
- Procedures or processes change.
- New equipment or products are introduced.
- Repeated deviations indicate gaps in knowledge.
- Annual Training Refreshers are due.
Periodic review of your training program will help ensure that it remains current and applicable.
Some common errors in training include:
Employees will feel more accountable for compliance with GMP principles if they understand why procedures have been developed and how their work contributes to the quality of the finished product.
As a result, the company as a whole will experience:
There are examples of these tools:
1) Learning Management Systems – Automate scheduling, tracking and certification
2) Micro-learning Modules – Short focused videos/quizzes - to provide short bursts of reinforcement.
3) VR Simulations – For training on aseptic or hazardous processing.
4) Mobile – Allow flexible access to training materials at any time and from any location.
By using these tools, organizations will increase the type of engagement that their employees have and will provide consistent delivery of training across their global workforce.
Conducting proper cGMP (current Good Manufacturing Practices) Training is not merely a desire to meet or satisfy a regulatory requirement; it provides your organization with a means of providing quality empowerment to your Personnel, so they can make sure that the processes they perform everyday help maintain Quality.
A successful cGMP training program consists of determining needs (i.e. what's needed), developing relevant content, delivering the training through trained instructors and assessing/capturing the results of the training on an ongoing basis. Re-training should be a continuous process; documenting the process should take place; and incorporating digital technologies should occur to ensure that compliance and performance are sustained.
When completed properly, cGMP training will convert employees from being task-based workers into being quality champions. These individuals will become your company's strongest deterrent against non-compliance.
This article will provide information regarding how to administer an effective, compliant and interesting cGMP training program to your employees, from planning, delivering and evaluating the program to continually improving upon the program over time.
Understanding the Purpose of cGMP Training
cGMP training is about ensuring all employees know the critical principles, policies and responsibilities to produce safe and effective products. Some key goals of cGMP training are:- To comply with the regulations 21 CFR Part 211.25 and Schedule M
- To minimize the risk of deviation from regulations, non-conformance and data integrity.
- To create a culture of accountability and quality.
- To prepare for both internal and regulatory inspections of the facility.
Regulatory Requirements for Training
Regulatory agencies require training under their GMP regulations as follows:FDA CFR 211.25(a): "Everyone involved in manufacturing, processing, packing or storing a drug product must have the education, training and experience to perform the functions assigned to them."
EU GMP 2.9: "Employees are to have an understanding of the principles of GMP which apply to them with regard to both initial and continued training."
WHO GMP (Annex 2): Suggests documented and regularly conducted training programs according to the job responsibilities of the employee.
Training must be relevant to the individual (according to the requirements of that individual), documented, complete and ongoing - training is not a one-time event.
Steps to Conduct Effective cGMP Training
Conducting effective cGMP training is completed using a consistent and structured approach which ensures that all training programs met both compliance requirements and produce a positive impact.To create successful and effective cGMP training the following are essential steps:
A. Conduct a Training Need Assessment
Before any program is created determines what types of knowledge and experience people need that are not being provided in your organization.The methodology used to assess the training needs include:
- Review of job descriptions and SOP responsibilities.
- Interviews and/or surveys of current knowledge.
- Using incident reports, CAPAs and audit issues/reports to identify continuing issues.
Develop and make training relevant to each department whether production, QA, maintenance and warehouse operation.
B. Create a Comprehensive Training Plan
An annual comprehensive training plan allows employees to receive up-to-date, relevant training.There are four important components to include in a training plan:
1. Training objectives.
2. Schedule of refreshers and training sessions at initial employment, scheduled periodic refresher training or scheduled change control based training.
3. Training delivery methods; classroom, e-learning, practical demonstration and hands-on and workshops.
4. Assigned Trainer.
5. Documentation of evaluation method; written tests, practical testing and observational checklists.
Each comprehensive training plan should align with a company’s quality system and regulatory requirements.
C. Design Training Curriculum
The effectiveness of cGMP training depends on the relevancy of the content and the clarity of the information presented.Training for New Employees (induction training):
– Overview of GMPs.
– Overview of company policies, company organization and quality system.
– Overview of health/hygiene/safety policies.
– Overview of documentation/data integrity principles.
Training for Existing Employees (role/position-specific training):
– Overview of SOPs (standard operating procedures) for your area/department.
– Overview of operating your equipment (operational use, calibration, cleaning).
– Overview of good documentation practices.
– Overview of how to document/manage deviations/change controls/corrective and preventative actions.
– Overview of product-specific training for manufacture and QC personnel.
Training for Management-level Employees:
– Overview of the development of risk management plan and implementation of a QMS.
– Overview of how to prepare for and conduct internal audits.
– Overview of how to prepare for and conduct a successful FDA inspection.
– Overview of root cause analysis/practice/continuous improvement practices.
Pro Tip: Make the training interactive and use photographs, case studies and actual examples from your own operations to keep the information fresh in people’s minds.
D. Pick Appropriate Training Techniques
There are many ways for employees to learn and using many types of training tools helps keep the employee engaged and better helps them process what they learned.The types of training used:
Classroom Training: Most effective for learning about theories and group interactions.
Hands-on Training: Most effective for training on equipment operation, aseptic techniques or laboratory procedures.
E-learning: Provides a flexible learning structure and includes quizzes and video training.
Mock Auditing & Simulation: Prepares employees for real-life inspecting scenarios and demonstrates where training gaps exist.
On-the-Job Training: Using a supervisor or qualified trainer to demonstrate job performance is best for learning given the real-life working environment.
For Example:
Utilizing both classroom-based training, along with practical-based training can be the best way to provide maximum effectiveness in providing employee training.
E. Trainer Qualifications and Selection Criteria
The trainer is critical in delivering correct and appropriate information regarding work standards.Criteria used to select a suitable trainer includes:
- Expertise in the area being trained in subject matter.
- Good communication skills.
- Good teaching skills.
- Knowledge of GMP regulatory guidelines and compliant with best practice
F. Schedule and Conduct Training Sessions
The training sessions for the group of technicians should be scheduled with some degree of advance notice and also be placed on the training calendar.Best Practices
- During critical production periods, avoid scheduling training sessions for maximum participation.
- Keep a record of attendance and a log of training held for each training session.
- Keep the training sessions as brief as possible (30 to 60 minutes) to keep the participants interested in continuing.
- Facilitate/encourage interactions during training - through Q&A sessions / group activities / case discussion / etc.
G. Evaluation of Training Effectiveness
The regulatory agency require that training be effective in nature and not just completed or administered.Assessing the effectiveness of training can be accomplished through the following methods:
1. Knowledge checks - utilizing written and/or online quizzes after each training session.
2. Practical evaluation - through observation of the individual technician's performance during performing the respective task and/or mock inspections.
3. Feedback forms - the technician should provide input in the form of an evaluation form, to assist in the refinement of future training sessions.
4. Trend Analysis - review of the number of deviations/errors, prior and post training sessions.
If the participant does not pass the evaluation or repeatedly makes the same errors after the completion of training, they must be trained again or coached.
H. Documentation & Recordkeeping
In GMP, ‘Everything Should Be Documented because Otherwise It Didn’t Happen’.Documentation of all training events must be accessible at the time of inspection.
Essential documentation includes:
- Training Attendance Sheets with Original Signatures.
- Copies of Training Materials/PowerPoints
- Test Results and/or Evaluation Forms
- Trainer Qualification Files
- Training Summary Reports
It is recommended that you use a TMS or LMS to automate the scheduling and tracking of training and your records.
I. Continuous Improvement and Re-Training
Training is not a once and done, but rather through continuous improvement; knowledge continues to evolve through regulations and technology.Re-training should occur when;
- Procedures or processes change.
- New equipment or products are introduced.
- Repeated deviations indicate gaps in knowledge.
- Annual Training Refreshers are due.
Periodic review of your training program will help ensure that it remains current and applicable.
Common Mistakes in cGMP Training
Even the best-intentioned training programs can have problems if they are executed poorly.Some common errors in training include:
- Training to only fulfill your compliance responsibility.
- Utilizing outdated or irrelevant content in training.
- Providing too much information at one time during training.
- Disregarding experiential, on-the-job training.
- Not following up with assessments or feedback after the training session has been conducted.
Building a Quality Culture Through Training
Effective cGMP training extends beyond compliance and builds a quality first mindset through group training, for every level of an organization.Employees will feel more accountable for compliance with GMP principles if they understand why procedures have been developed and how their work contributes to the quality of the finished product.
As a result, the company as a whole will experience:
- Fewer deviations and reworks.
- Improved documentation accuracy.
- Better prepared for inspections.
- Enhanced overall compliance.
Using Digital Tools for Modern Training
Pharmaceutical Firms are turning to digital tools/platforms to improve their training processes and modernize them to meet their needs.There are examples of these tools:
1) Learning Management Systems – Automate scheduling, tracking and certification
2) Micro-learning Modules – Short focused videos/quizzes - to provide short bursts of reinforcement.
3) VR Simulations – For training on aseptic or hazardous processing.
4) Mobile – Allow flexible access to training materials at any time and from any location.
By using these tools, organizations will increase the type of engagement that their employees have and will provide consistent delivery of training across their global workforce.
Conducting proper cGMP (current Good Manufacturing Practices) Training is not merely a desire to meet or satisfy a regulatory requirement; it provides your organization with a means of providing quality empowerment to your Personnel, so they can make sure that the processes they perform everyday help maintain Quality.
A successful cGMP training program consists of determining needs (i.e. what's needed), developing relevant content, delivering the training through trained instructors and assessing/capturing the results of the training on an ongoing basis. Re-training should be a continuous process; documenting the process should take place; and incorporating digital technologies should occur to ensure that compliance and performance are sustained.
When completed properly, cGMP training will convert employees from being task-based workers into being quality champions. These individuals will become your company's strongest deterrent against non-compliance.
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