What is the Training SOP about?

Human resources is one of the most valuable assets for any organization and a key to producing quality products. Regulatory authorities require policy, plan and system to be established for resource management.

Training is an essential component for human resources management and for ensuring the workforce is appropriately competent to perform its duties. This Standard Operating Procedure (SOP) covers all aspects of training requirements from first day orientation to periodic re-training for employees, temporary staff, visitors and contractors to ensure GMP is not violated and product quality is not at risk.

This SOP incorporates all training requirements and activities:

• New employee orientation
• Checklist of training requirements for GMP processes and SOP’s.
• Responsibilities for all parties
• Self taught training option
• Re-training requirements

This well-proven SOP has been used successfully in a well established regulated facility.

This document package is in 2 parts:

• Part 1 - 2 page introduction and referencing regulatory requirements
• Part 2 - 14-page document template including a valuable “folding pocket guide” for Visitors and Contractors summarizing GMP requirements; Plus 3 associated forms – Attendance, Self-Training and Visitor register.

Table of Contents

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Regulatory Requirements & Guidelines:

• FDA 21 CFR PART 211 -- cGMP for Finished PharmaceuticalsSubpart B--Organization and Personnel, Sec. 211.25 Personnel qualifications
• FDA Guidance for Industry – “Quality Systems Approach to Pharmaceutical CGMP Regulations”, Section 2. Personnel Development
• ISO-9001 Section 6 Resource Management, 6.2 Human Resources -Competence, Training, and Awareness
• PICS PE 009-8 2009 02 Part2 Guide GMP Medicinal Products; Section 3.1 Personnel Qualifications

Keywords:

Training Policy SOP

Associated Documents:

Q06-0102 Training Master Plan
Q06-0104 Training Laboratory Analysts
Q04-0110 Change Control
Q04-0111 Document Change Control Procedure
Q04-0111F01 Document/SOP Training Requirements