General requirements for personnel

Staff must understand how they can influence quality, GMP compliance and contribute to improvement. Staff at all levels must be competent and be effectively managed.

It is stated that the responsibilities of all personnel engaged in the manufacture of intermediates and APIs should be specified in writing.

This can be accomplished either in a generic way for a group of personnel e.g. warehouse personnel or operators in chemical production.

For persons having a more specific responsibility, e.g. supervisors, process engineers, it might be more proper to have individual responsibilities laid down for instance in a function description.

A possible way of indicating this is to use a matrix in which the responsibilities are defined. Another way of doing it could be the use of separate columns in a process flow chart indicating which unit or function (person) is responsible for what action.

Job descriptions or function descriptions should identify the main purpose, role dimensions, outputs/responsibilities, reporting details and required competencies. These should be reviewed regularly.

Place of work and job descriptions
Requirements of the personnel
World Health Organization Training Requirements
Discussion Forum



Key Personnel

Qualified Person (QP):
 - Requirements of the Qualified Person in accordance with European law
 - Area of responsibility of the Qualified Person in accordance with European Law
 - Organisational appointment/substitution regulations
 - Head of Production
 - Head of Quality Control
 -  Qualified Person in Accordance with Article 103 of Guideline 2001/83/EC
 -  Scientific Service in Charge of Information
 -  Medical sales representatives




Training should range from basic "induction" training through to job specific training. Employees should receive initial GMP awareness training as well as more focused training (e.g. document management for those involved in document control functions.) GMP refresher training should be conducted at least annually.

Training in particular operations that the employee performs might be carried through under supervision by a person qualified by education, training and experience.

Before a person is allowed to sign a particular operation in the batch record he should be qualified by education or should have received appropriate training.

GMP training should be scheduled regularly and conducted according to a plan.

Training records should indicate the following:
names of the people trained,
subject of training in keywords
date of training
name of trainer

If procedures are revised or newly released the need for appropriate training should be assessed.

Effectiveness of training can be verified by direct (e.g. testing, questionnaire) and/or indirect means, e.g. individual observations, periodical assessment (usually annual) interview with supervisor or Internal Audits.

Purpose of training
Responsibility for training
Requirements profiles/learning objectives
Training contents and target groups
Training planning
Carrying out
External factors
Qualification of the trainer
Training methods
Reviewing the training and the training system
Training activities



Personnel hygiene

The intention of this chapter is to protect personnel as well as products. The type of protection garments for each chemical operation may be given in the production or safety instructions. These instructions should be followed and checked.

Personal hygiene should also be practised by maintenance staff, contractors, visitors, consultants, and inspectors as appropriate.

Personnel hygiene
Production hygiene
Sanitation programme
Discussion Forum