Making GMP training relevant

Good Manufacturing Practice (GMP)

GMP is a system that ensures consistent production of high quality products. GMP processes at each stage of production aids in maintaining the quality of every finished batch and helps eliminate errors that cannot be rectified in a finished product.1,2 Most countries have developed GMPs by adapting GMP guidelines laid down by the World Health Organization (WHO).1 USFDA closely monitors all products manufactured by the pharmaceutical industries to ensure their compliance to current GMP (CGMP) guidelines.

The importance of CGMP

CGMP guidelines give an organization the flexibility to decide on ways to use latest technologies, equipment, and systems to produce high-quality drugs without compromising on the therapeutic efficacy and safety of a drug. The USFDA has expert staff who conduct routine inspections on manufacturing facilities to check adherence to CGMP guidelines. In addition, there are numerous public outreach programs conducted by the USFDA to spread awareness about GMP requirements and any changes in policies.3

Key specifications of GMP2,4

The important components of GMP are:

  • Quality management: Appropriate design and maintenance of facilities and equipment
  • Qualification of personnel: Employing certified individuals for their respective roles
  • Quality control
    • Up-to-date documentation
    • Personnel training and development
    • Personal hygienic practices
    • Robust life cycle management of a product including product recall or complaints
    • Periodic auditing including supplier’s audits
  • Quality assurance: Validation of all processes and standard operating procedures

Who qualifies for GMP training?

Any person directly or indirectly involved in the manufacturing, processing, packing, holding, or distribution of a drug product should undergo GMP training on a periodic basis. These include junior or senior management personnel, IT staffs, or support staffs that directly or indirectly have jobs that are regulated under GMP.

The importance of GMP training

It is important for employees to be familiar with CGMP so that they can execute assigned tasks in compliance with the local legal requirements. Annual GMP refresher training is also recommended to reinforce the importance of GMP. It also helps in keeping the employee aware of any changes to the local or international regulatory rules as well as to disseminate information on any changes to internal operations of an organization.5

From a global perspective, effective GMP training offers the advantage of the industry being viewed as a reliable partner that have systematic documentation processes, process improvement activities, and cost-effective strategies that help maintain the final product quality.6

Common problems encountered during GMP training

Providing a generic GMP training can easily disinterest new participants or experienced personnel who question the applicability of many of the guidelines in their work area. Many of the GMP training patterns do not consider the employee’s needs nor do they draw the attention of employees who could become potential trainers.7 In addition, most training programs focus only on the regulations and may not cover the practical application of GMP. Another drawback noted is the duration of GMP training in itself. Information overload in a single session can have counterproductive effects with participants missing crucial knowledge and skill transfer.

Requirements for an engaging and impactful GMP training

While training on GMP is mandatory for new and existing staff, many of these trainings come across as irrelevant and sketchy. Some points that could make GMP training effective and engaging are:

    • Brief history of the genesis of GMP: Emphasize the criticality of GMP by providing historical data on how unregulated production and use have had serious consequences on many human lives such as the thalidomide tragedy of the 1960s, poisoned acetaminophen capsules of the 1990s and more.8
  • Tailor-made GMP training: GMP training should be flexible and structured to suit the target audience. For instance, the requirement of a new employee is different from that of a seasoned employee of a company. A new employee would need a general orientation about the company and its organizational chart along with work-specific orientations including on-the-job training. An experience employee would benefit from reinforcement and continuous trainings in order to keep them updated about any changes to GMP guidelines.9
  • Bringing subject matter experts (SMEs) to the forum: Trainers with advanced technical knowledge and skill should be assigned the task of training on GMP processes and guidelines. SMEs have the expertise to break down complex and critical activities that are involved in risk management, thereby confidently equipping employees in charting out an effective risk mitigation plan.10
  • Setting learning objectives: The trainer should make a concerted effort to present credible data, case studies, and strategies to alleviate the most commons doubts that arise in a participant; “Why should I do this training?” and “What do I take back from this training?”. Examples of useful learnings could be:
  • any regulatory update or enforcements that could have an impact on the participant’s work, or 
  • projection of quality metrics of the organization and the positive effects of following GMP guidelines, and so on.11
  • Creative and interactive training: Incorporating short practice sessions and activities at the end of each segment or module not only aids in practical application but also better knowledge retention in the participant. 
  • Use of eLearning modules to enable self-learning: E-learning modules comprising of many short videos are more effective in holding the attention span of an employee than a single presentation of the GMP guidelines.12
  • Assessment of training effectiveness: To what extent has the training been effective can be assessed by conducting online or written assessments. Such assessments in turn help evaluators look for any gaps in the training content.
  • Feedback: Another pivotal way to gauge the effectiveness of GMP training would be to solicit anonymous feedback or to encourage employees to share their experiences at the end of a training session.

Outcome of an effective GMP training

From a regulatory perspective, a successful GMP training program should have well-laid standard operating procedures and proper documentation. The curriculum should have details of the scope of the training, training frequency, and qualification of the trainer. Ultimately, the success of a GMP training would be reflected when the employees translate what they have imbibed into their respective workspaces.

Sources

  1. World Health Organization. Essential medicines and health products. https://www.who.int/medicines/areas/quality_safety/quality_assurance/gmp/en/. Accessed on April 8, 2020.
  2. International Society for Pharmaceutical Engineering (ISPE). (2020). https://ispe.org/initiatives/regulatory-resources/gmp. Accessed on April 8 2020.
  3. Facts about Current Good Manufacturing Practices (CGMP). USFDA. https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps. Accessed on April 8, 2020
  4. Karmacharya JB. Good Manufacturing Practices (GMP) for Medicinal Products. https://cdn.intechopen.com/pdfs/37170/InTech-Good_manufacturing_practices_gmp_for_medicinal_products.pdf. Accessed on April 2, 2020.
  5. Patel KT and Chotai NP. Documentation and Records: Harmonized GMP Requirements. Journal of Young Pharmacists. 2011;3(2):138-150.
  6. Nulogy. https://nulogy.com/challenges/compliance/gmp-compliance/. Accessed on April 8, 2020
  7. https://www.complianceonline.com/resources/gmp-training-101.html. Accessed on April 8, 2020.
  8. Immel BK. A Brief History of the GMPs for Pharmaceuticals. Pharmaceutical Technology. 2001. https://gmpnews.ru/wp-content/uploads/2010/05/History-gmp.pdf
  9. A WHO guide to good manufacturing practice(GMP) requirements. Part 3: Training. Immunization, Vaccines and Biologicals. 2006. https://apps.who.int/iris/bitstream/handle/10665/69396/WHO_IVB_05.24_eng.pdf;jsessionid=70363FFC0EE21E4AC15E1E0C67F7A8AE?sequence=1. Accessed on April 8, 2020.
  10. Welty G. Developing a Continuing CGMP Training Program. Journal of GXP Compliance. 2009;13(4):86-96. http://www.wright.edu/~gordon.welty/J_GXP_C_Continuing_10_09.pdf
  11. The QA Pharm. Top 10 Ways to Make GMP Training Relevant. 2012. https://www.manufacturing.net/home/blog/13158647/top-10-ways-to-make-gmp-training-relevant. Accessed on April 8, 2020
  12. ECA Academy. Your GMP/GDP information source. https://www.gmp-compliance.org/gmp-news/how-to-manage-efficiently-annual-gmp-trainings. Accessed on April 8, 2020.

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