Personnel Training Procedures for MDI Production
1) Purpose
The purpose of this SOP is to establish procedures for the training of personnel involved in the production of metered-dose inhalers (MDIs) to ensure competency, adherence to procedures, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in MDI production, including production operators, technicians, quality control staff, and supervisors, who require training on specific tasks and procedures.
3) Responsibilities
The responsibilities for this SOP include identifying training needs, conducting training sessions, assessing competency, and maintaining training records. Specific roles include:
Training Coordinators: Identify training requirements and schedule training sessions.
Trainers: Conduct training sessions and evaluate trainee performance.
Supervisors: Monitor the effectiveness of training and provide ongoing support.
4) Procedure
4.1 Training Needs Assessment
4.1.1 Identify job roles and tasks that require training based on job descriptions and SOPs.
4.1.2 Assess competency gaps through skills assessments or performance evaluations.
4.2 Training Program Development
4.2.1 Develop training programs based on identified needs and training objectives.
4.2.2 Include training materials, resources, and evaluation methods in the training plan.
4.3 Training Delivery
4.3.1
4.3.2 Ensure trainers are qualified and provide clear instructions during training.
4.4 Competency Assessment
4.4.1 Evaluate trainee competency through practical assessments, quizzes, or simulations.
4.4.2 Document assessment results and provide feedback to trainees.
4.5 Training Records
4.5.1 Maintain training records, including attendance sheets, assessment results, and training evaluations.
4.5.2 Ensure records are accurate, up-to-date, and accessible for audits and inspections.
5) Abbreviations, if any
MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure
6) Documents, if any
Training plans, training materials, competency assessments, and training records should be maintained.
7) Reference, if any
Refer to regulatory guidelines from agencies such as the FDA, EMA, and ISO 13485 for training requirements in pharmaceutical manufacturing.
8) SOP Version
Version 1.0
