Training - GMP SOP

Training is considered an essential tool for human resources management and for ensuring the workforce is appropriately qualified to perform its duties. This Standard Operating Procedure (SOP) covers the training skills level required of site personnel (including temporary personnel) who perform skilled functions (i.e. GMP, etc.) where product quality and the quality system itself could be adversely affected by a lack of appropriate skills.

This Standard Operating Procedure (SOP) was written to incorporate all comprehensive training activities into one system to ensure that all personnel acquire the skills, knowledge and qualifications needed to effectively carry out their duties and tasks. This SOP (Standard Operating Procedure) can be applied to all pharmaceutical GMP-regulated areas such as drug products, active pharmaceutical ingredients, excipients, vaccines and medical devices. This 15-page SOP includes 5 attachments: an on-the-job training form, a training needs analysis form, a course evaluation form, an attendance register form and a training course attendance request form.