pharmaceutical requirement for personnel as per GMP

1. Prepared by: Ramji dwivedi
(B.Pharma 4th year)
Personnel requirement as per GMP

2. Contents
• Introduction
• Personnel requirement as per GMP
• Requirement for GMP
• Principle
• General
• Key Personnel
• Training
• Personal Hygiene
• Reference

3. Introduction
 GMP is that part of Quality assurance which ensures that the
products are consistently manufactured and controlled to the
Quality standards appropriate to their intended use
 There must be sufficient qualified personnel to carry out all the
tasks which are the responsibility of the manufacturer

4. Personnel requirement as per GMP
• 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.

5. Requirement for GMP
• Principle
• General
• Key Personnel
• Training
• Personal Hygiene

6. Principle
• maintenance of a satisfactory system of quality assurance and the
correct manufacture of medicinal products relies upon people
• there must be sufficient qualified personnel to carry out all the tasks
which are the responsibility of the manufacturer.
• All personnel should be aware of the principles of Good
Manufacturing Practice

7. General
• The manufacturer should have an adequate number of personnel
with the necessary qualifications and practical experience
• The manufacturer must have an organization chart
• People in responsible positions should have specific duties
• Their duties may be delegated to designated deputies of a
satisfactory qualification level.

8. Key Personnel
• the head of Production
• the head of Quality Assurance
• the head of Quality Control

9. Training
• The manufacturer should provide training for all the personnel
• whose duties take them into production areas or into control laboratories
(including the technical, maintenance and cleaning personnel)
• and for other personnel whose activities could affect the quality of the product.

10. Personal Hygiene
• Detailed hygiene programmes should be established and adapted to the different needs
within the factory.
• They should include procedures relating to the health, hygiene practices and clothing of
personnel.
• These procedures should be understood and followed in a very strict way by every person
whose duties take him into the production and control areas.
• Hygiene programmes should be promoted by management and widely discussed during
training sessions.