Standard Operating Procedure for Training of Personnel in Otic Manufacturing Unit
1) Purpose
To establish procedures for training personnel involved in the manufacturing of Otic (Ear) Dosage Forms to ensure competency, compliance, and adherence to Good Manufacturing Practices (GMP).
2) Scope
This SOP applies to all personnel engaged in manufacturing, quality control, quality assurance, and related functions within the Otic manufacturing unit.
3) Responsibilities
Human Resources Department: Responsible for coordinating and documenting training activities.
Department Heads: Responsible for identifying training needs and ensuring participation of their respective teams.
Trainers: Responsible for conducting training sessions and assessing trainee competency.
4) Procedure
4.1 Training Needs Assessment
4.1.1 Identify Training Needs
4.1.1.1 HR collaborates with department heads to identify job-specific training requirements.
4.1.1.2 Assess competency gaps and regulatory requirements for each role.
4.1.2 Training Plan Development
4.1.2.1 Develop an annual training plan based on identified needs and departmental goals.
4.1.2.2 Include mandatory GMP training and role-specific competencies.
4.2 Training Program Implementation
4.2.1 Training Session Organization
4.2.1.1 Schedule training sessions based on the training plan.
4.2.1.2 Notify participants and ensure availability of training materials and resources.
4.2.2 Conducting Training
4.2.2.1 Trainers deliver content using approved training materials and methods.
4.2.2.2 Facilitate interactive sessions and practical demonstrations as applicable.
4.3 Training Evaluation
4.3.1 Assessing Trainee Competency
4.3.1.1 Conduct evaluations to measure trainee understanding and application of training content.
4.3.1.2 Document assessment results and provide feedback to trainees.
4.3.2 Effectiveness Review
4.3.2.1 Evaluate training effectiveness based on feedback and post-training performance.
4.3.2.2 Identify opportunities for improvement in training delivery and content.
4.4 Training Record Keeping
4.4.1 Documentation
4.4.1.1 Maintain accurate records of training sessions attended and completed by personnel.
4.4.1.2 Document training outcomes, assessments, and any corrective actions taken.
4.4.2 Retraining and Refresher Courses
4.4.2.1 Schedule periodic retraining sessions to reinforce GMP principles and updates.
4.4.2.2 Offer refresher courses as needed to maintain competency and compliance.
5) Abbreviations, if any
SOP: Standard Operating Procedure
GMP: Good Manufacturing Practices
HR: Human Resources
6) Documents, if any
Annual training plan
Training session schedules
Training evaluation forms
7) Reference, if any
GMP guidelines for personnel training in pharmaceutical manufacturing
8) SOP Version
Version 1.0
