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.

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Description

Table of Content

1. Regulatory Basis, Reference Documents
2. Purpose
3. Scope
4. Responsibilities and Accountabilities
4.1 Management Team and Supervisory Staff
4.2 Quality Manager
4.3 Human Resources Officer
4.4 Technical Director
5. Training Procedure
5.1 Orientation Program (induction)
5.2 On-the-Job Training
5.3 Needs Analysis
5.3.1 GMP Training
5.3.2 Ad hoc GMP Training
5.3.3 Environment Health and Safety Training
5.4 Training schedule
5.5 Registering of names
5.6 Training execution
5.7 Training follow-up
5.8 Non-Attendance of courses
5.8 Training records
6. Definitions
7. Distribution
8. Attachments
Appendix 1: On-the-Job Training Form
Appendix 2: Training needs analysis form
Appendix 3: Course evaluation form
Appendix 4: Attendance register
Appendix 5: Request to attend training course form

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SKU Training - GMP SOP

FDA-EMA

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Delivery item: Word Document
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Please note: We do not deliver hard copies.


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