Standard Operating Procedure for Training of Personnel in Vaginal Dosage Form Manufacturing
1) Purpose
The purpose of this SOP is to define the procedure for training personnel involved in the manufacturing of vaginal dosage forms to ensure competency and compliance with GMP requirements.
2) Scope
This SOP applies to all personnel involved in the manufacturing, packaging, testing, and distribution of vaginal dosage forms at [Company Name].
3) Responsibilities
The Human Resources (HR) Department is responsible for coordinating and documenting training activities. Department heads are responsible for identifying training needs within their departments.
4) Procedure
4.1 Training Needs Identification
- Department heads identify training needs based on job roles, new hires, changes in procedures, or identified skill gaps.
4.2 Training Plan Development
- HR develops an annual training plan based on identified needs and regulatory requirements.
- Include topics such as GMP principles, specific SOPs, safety procedures, and job-specific skills.
4.3 Training Delivery
- Assign trainers qualified in the subject matter to conduct training sessions.
- Deliver training through workshops, seminars, on-the-job training, or external courses as appropriate.
4.4 Competency Assessment
- Assess trainee competency through quizzes, practical assessments, or evaluations.
- Document assessment results and provide feedback to trainees.
4.5 Training Records
- Maintain training records including attendance, topics covered, assessments, and certificates of completion.
- Ensure records are up-to-date and accessible for regulatory inspections.
5) Abbreviations, if any
GMP: Good Manufacturing Practice; HR: Human Resources; SOP: Standard Operating Procedure
6) Documents, if any
Training plan template, Training record forms
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, WHO Technical Report Series No. 986, Annex 3: WHO good manufacturing practices for pharmaceutical products: main principles
8) SOP Version
Version 1.0
