Personnel requirement as per gmp

pharmaceutical requirement for personnel as per GMP

1. Prepared by: Ramji dwivedi (B.Pharma 4 th 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.