Home > A Guide to Good Manufacturing Practice Requirements

Introduction and purpose of this guide:

Regulatory agencies around the world require that training on good manufacturing practices (GMP) be conducted on a regular basis for those who are involved in producing pharmaceutical and biological products. Documentation is also needed as evidence that the training occurred. More and more frequently, regulatory agencies and their inspectors are requesting evidence that the training was effective.

While regulatory agencies have these requirements and expectations, they give few specific details as to how the training is to be performed; they do not say how it should be done. To date, no guidance document on training for industry has been available from any regulatory agency or official (governmental, nongovernmental or industrial) organization. Unfortunately, this lack of guidance may cause some in industry to think that training is a simple process. However, for training to be an effective and efficient tool that contributes to performance, it must be done properly.

It is not unusual for someone, when first given the responsibility for training a drug or vaccine workforce, to realize the complexity of training; things that seemed obvious or unimportant from the outside now demand specific simple, clear answers.

Some of the frequent questions of new trainers or training managers include:

• What training is required for each area or each worker?
• How frequently should training be performed?
• How can I design an effective training programme or course?
• Who is responsible for training?
• Can all experts be trainers?
• How can the results of training be evaluated and assessed?
• How should training be documented?

This guide has been prepared to aid vaccine manufacturers in the planning, conducting and evaluation of training programmes required by good manufacturing practices of the World Health Organization (WHO). It is not meant to restrict in anyway the freedom that manufacturers have to provide training in the way they consider best for their staff.

It has been written to help both trainers and supervisors solve some of the problems they face involving training, such as how to make the training interesting to adult learners or how to effectively use a variety of instructional methods.

This guide can also benefit those whose work is related to training activities in a vaccine manufacturing facility. It can be used in either of two ways, as an information tool or as additional reading during a structured workshop for developing effective trainers.

The guide presents the GMP requirements on training from different regions and countries of the world, an overview of the training process, types of training and different groups requiring  training, the instructional systems design (ISD) model, and some considerations to make training more effective. This guide also discusses what to include in a training procedure. Different evaluation and assessment methods are explained along with ways to plan and document training.

In addition to the examples found in the chapters, some documents contributed by vaccine manufacturers who cooperated in this project have been included as annexes. The guide also includes selected statements regarding training from different authors.

As in most other disciplines and endeavours, there are different approaches that can be used to reach a particular goal. The models and examples presented here are based on the training, experiences (some of which were successful and others not), and work that the authors have done in training and in the pharmaceutical and vaccine industry. It is meant to be a guide; not a rigid formula that must always be followed.

It is clear that this guide is intended as a first step to approach this topic. Suggestions for specific ways in which this guide could be more useful to trainers, training coordinators, supervisors, quality assurance and human resources staff would be welcomed by the authors and WHO for its future editions.

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