Audit - 03

Audit Manual 03 - Auditing a Personnel & Training System

Perform an audit of a personnel and training system. Know and understand which of the worldwide requirements apply to personnel and training. Use a range of information tools, including the contents of this module in support of a personnel and training

Audit 03 - Auditing a Personnel & Training System

Within the pharmaceutical industry it is agreed that people are the most important element in any pharmaceutical operation. The number of people working at a site needs to be sufficient to ensure that the drug product manufactured, processed, packaged, or held are compliant with all necessary GMP and regulatory requirements. Personnel must be qualified and have the right attitude, training, and supervision to produce good quality product.

The company or site should have an organization chart and/or clearly defined reporting structure. There should be no gaps or unexplained overlaps in the responsibilities of personnel concerned with the application of GMPs. There should be a Quality unit/Quality Assurance Unit (QA) that is independent from production, up to an appropriate level in the organization. The level of separation of QA from Production is determined by the company’s organization and size.

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