GMP Training 101: A Primer on 'Why, Who, What, Which, and How' of Creating an Effective GMP Training Program

If you want to obtain and maintain GMP compliance, you must proactively develop your team, and participate in ongoing training programs. You must make it evident by your actions that following GMPs is the only way your company should do business. This article answers questions about creating a training program to help you develop a GMP compliant workforce.

Why GMP Training?

Training in Good Manufacturing Practices (GMPs) is a regulatory requirement

  • 21CFR211.25(a) requires employees to attend training, including GMP, specific to their job responsibility.
  • ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Section 3.12 also requires personnel to attend GMP training relevant to their functions.
  • Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients requires site staff training suitable to their job responsibility.

Training Fosters a Compliant Workforce

  • Effective training equips the workforce with the knowledge to achieve compliance with GMP in the pharmaceutical and associated industries.
  • Ongoing training programs that reflect the changes in the GMP regulatory expectations, guidance, or industry trends help the workforce stay current with the regulatory, operational, and technological area in the pharmaceutical arena.

Training helps avoid common pitfalls that usually result in citations

Taking a proactive approach to ongoing GMP training helps in avoiding common training mistakes and citations that are consequences of:

  • Lack of adequate training, education, and experiences needed to do the assigned functions.
  • Not training personnel on operations, GMPs or Standard Operating Procedures.
  • Insufficient training for supervisors
  • Lack of ongoing training or low training frequency
  • No adequate number of trained staffs performing or supervising functions.

Who should conduct the GMP training?

As per 21 CFR211.25 Personnel Qualifications and ICH Q7 Section 3.12, 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.

Who should receive GMP training?

As per 21CFR211.25 'Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions.'

GMP training can also be imparted to personnel who are indirectly involved in manufacturing and those in support roles. These may include senior management level, IT and other support staff, and anyone who directly or indirectly have jobs related to GMP-regulated area.

How frequently should GMP training be imparted?

Sufficient frequency of GMP training is required. However, the training should be ongoing and should be conducted at least annually. Usually, the frequency is determined based on the complexity of the activity. Generally, training is imparted when:

  • A new employee is hired
  • New SOPs are developed or revised
  • When the company implements new computer applications like the Quality Management Systems, or upgrades or changes the system.
  • Personnel commence specific relevant jobs or functions
  • When corrective actions detect personnel training as the root cause
  • When an employee returns to work after a long leave of absence or as a regular reminder

What are the common training pitfalls to avoid?

Pitfall #1: Imparting generic training

Generic training programs are commonplace and do not hold the attention of the audience. The following recommendations will help make the GMP training fun and engaging more appropriate.

  • Don't restrict it to only what is expected of the employee. Also, include why
  • Help the employee understand why a specific procedure is personally important to the employee, rather than how it benefits the company.
  • Customize training by role and locations
  • Include case studies, real examples of occurrences and the lessons drawn
  • Tailor graphical components such as layouts, logos, colors that represent the brand
  • Localize the content to the audience first language

Pitfall #2: Not taking into consideration the employee's needs

Taking into consideration the employees needs includes

  • Engaging the employee by training in small groups rather than large groups
  • Engaging trainers who are qualified, experienced, passionate and capable of training.
  • Keeping the training environment comfortable and distraction-free.

Pitfall #3: Not conducting ongoing training programs

As already covered in this article, the frequency of GMP training is paramount to achieving GMP compliance.

Pitfall #4: Not evaluating the effectiveness of the training program

To ensure training effectiveness, it's not enough to simply have the employee sign a sign-in sheet. In no way does it provide information about the retention of knowledge gained through the program.

End-of-course tests are highly effective in evaluating training effectiveness. Compiling the data of the test will help you determine the overall effectiveness and work on areas of improvement.

How to assess GMP training needs?

Training needs can be assessed through

  • Identification of key GMP positions for the training
  • Conducting interviews and surveys both qualitative and quantitative
  • Through performance reviews
  • Through direct observations of employees

What are the basic expectations of FDA inspectors about GMP training programs?

Training programs must be well documented and thorough. SOPs defining these programs are a requirement. The training program development must include:

  • Scope of the training program
  • Definition of responsibilities
  • Training frequency
  • Approval of the QA and QC units on the various elements of the training program including completeness, accuracy, relevancy, and meaningfulness of topics relevant to the company, GMP-training curriculum for job functions or positions
  • Training plan for required positions
  • Instructor qualification as described in the training SOP
  • Training documentation including of at least a sign-in sheet with each person's name, signature, name, and number of the course, date of the session, and the instructor's name and signature.
  • Documentation of training effectiveness

What are some effective programs about GMP Training?

A Holistic Approach to External GMP Surveillance, GMP Training and Quality Knowledge Management
GMP Training Practices to ensure Regulatory Compliance
Effective Annual U.S. FDA CGMP Training
Creating FDA-compliant cGMP Training Program