Page 16 - QA and QC

GMP Training – Quality Assurance and Quality Control by www.gmpsop.com

A key GMP principle is: "If It isn't documented, It wasn't done."

Personnel and training

The manufacture of quality products relies on people. Therefore, it is important
that personnel have the right skills, knowledge, and attitudes to perform their
work correctly and diligently. Types of training required by personnel include:

induction training

knowledge of GMP rules

SOP training (understanding of company procedures)

On-the-job skills training

The company must be able to demonstrate that training has been conducted
satisfactorily in the above areas by maintaining training records for each person.

GOOD TO KNOW – HUMAN ERROR AND BEHAVIOUR

The majority of incidents leading to defective drug products result not from
failures In technology, but from human error or simple mistakes. The behavior,
attitude, care, and knowledge of employees, therefore, are critical elements in
manufacturing safe drug products.
The company is required to document procedures and GMP rules, but they
have no value unless employees know and follow them in all their work
practices.

Internal audits

Well conducted internal audits, managed by QA, help companies identify any
weaknesses in any part of manufacturing or testing processes.

Internal audits:

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