OBJECTIVE:

• To establish a comprehensive procedure for training and development of all personnel to ensure competence, compliance with Regulatory requirements, and continual improvement of knowledge, skills, and performance.

 SCOPE:

• This SOP applies to all employees, contract staff, and temporary staff at [Company Name] whose activities may affect product quality, patient safety, or GMP compliance. It covers induction, on-job, GMP, SOP, safety, pharmacovigilance, behavioral, and retraining programs.

RESPONSIBILITIES:

• Quality Assurance (QA) / Designee Training:
  • • Shall develop and maintain the overall training system.
    • Shall prepare and update the annual training calendar and training matrix.
    • Shall review and approve training materials and training methods.
    • Shall ensure that only qualified trainers are authorized to conduct training.
    • Shall monitor the completion of training programs and evaluate their effectiveness.
    • Shall maintain master records of all training activities.
• Department Heads:
  • Shall identify training needs specific to their department.
  • Shall recommend employees for required training.
  • Shall ensure employees are released to attend scheduled training sessions.
  • Shall evaluate employee competency following training.
  • Shall provide feedback to the Quality Assurance on training effectiveness.
• Trainers:
  • Shall prepare training content and deliver training using approved materials and methods.
  • Shall conduct post-training assessments and provide feedback to trainees.
  • Shall document training attendance, results, and observations.
• Employees:
  • Shall actively participate in training sessions.
  • Shall complete all required assessments.
  • Shall implement knowledge gained during training in routine activities.
  • Shall acknowledge training by signing the attendance and training evaluation records.

DEFINATIONS:

• Good Manufacturing Practices (GMP): A set of principles and guidelines that ensure medicinal products are consistently produced and controlled according to quality standards appropriate to their intended use and as required by the marketing authorization.
•  Induction Training: Introductory training provided to all new employees before starting work. It covers company policies, GMP basics, safety rules, and job orientation.
•  On-Job Training (OJT): Practical, hands-on training conducted at the workplace. It involves demonstrating tasks, observing the trainee, and verifying competency before independent work.
•  SOP Training: Training on specific Standard Operating Procedures (SOPs). Provided at issuance, revision, or as refresher training to ensure employees follow approved methods accurately.
•  Safety & Environmental Training: Training covering workplace safety, hygiene, emergency response, and environmental protection measures to safeguard employees and prevent contamination.
•  Pharmacovigilance Training: Role-specific training for employees involved in product safety reporting. It ensures proper handling of adverse drug reactions, complaints, and inquiry management.
• Behavioral/Leadership Training: Development programs to improve communication, teamwork, decision-making, and leadership skills. Applicable to supervisors, managers, and future leaders.
•  Retraining / CAPA Training: Additional training provided when an employee returns after >90 days absence, or in response to deviations, audit findings, product complaints, or CAPA implementation, to reinforce compliance.

 PROCEDURE:

Role-Based Training Requirement Analysis:

• Training needs shall be identified annually and whenever there are changes in regulatory requirements, procedures, processes, or job responsibilities.
•  Department Heads shall submit training requirements to the Designee QA using the Training Needs Identification Form
•  The Designee shall consolidate the needs, perform a gap analysis, and finalize the training requirements for the year.
•  Training Attendance shall be recorded in Training Attendance sheet

 Training Calendar and Training Matrix:

• Based on identified needs, the Designee QA shall prepare an annual training calendar specifying the training topics, target audience, trainers, and schedule.
•  A training matrix shall be maintained to map individual employees against the training they are required to complete
• Both the calendar and matrix shall be reviewed quarterly and updated in case of new employees, role changes, SOP revisions, or regulatory changes.

 Training Delivery:

• Training shall be delivered using classroom sessions, workshops, practical demonstrations, presentations, or e-learning modules, Workplace training as appropriate.
• Training shall be conducted in the language where necessary to ensure comprehension.
• Only trainers approved by Quality Assurance shall be authorized to conduct training sessions.
• All training materials (presentations, SOPs, videos, handouts) shall be reviewed and approved by the Designee QA prior to use.

Evaluation of Training Effectiveness:

• Effectiveness of training shall be evaluated immediately after completion of the session.
•  On-Job Training: The supervisor shall verify competency through direct observation using the OJT Checklist .
• Classroom Training: Trainees shall complete a written test or questionnaire.
• A minimum score of 80% is required to qualify.
• Employees who do not meet the passing criteria shall undergo retraining within 15 working days.
• Supervisors shall further confirm application of knowledge during routine performance evaluations.

 Retraining:

• Retraining shall be conducted in the following circumstances:
  • • When employees return from long leave (>90 days).
    • When significant changes are introduced in SOPs, processes, or regulatory requirements.
    • When deviations, non-conformances, audit findings, or product complaints highlight gaps in training.
    • As part of CAPA implementation.
•  Retraining records shall clearly indicate the reason for retraining and shall be linked to the respective deviation or CAPA reference.

Training of Internal Trainers (Train-the-Trainer Program):

• All employees designated as trainers shall undergo a structured qualification program prior to conducting any training.

• The qualification program shall include:
  • Demonstration of subject matter expertise in the relevant SOPs, GMP principles, or technical processes.
  • Training in presentation skills, communication techniques, and use of training aids.
  • Familiarization with company-approved training formats (attendance sheets, evaluation sheets, feedback forms).
  • Awareness of adult learning principles to ensure effective knowledge transfer.

• The Designee QA shall evaluate and approve the competency of trainers using the Trainer Qualification Checklist.
• A List of Approved Trainers shall be maintained and updated annually.
• Trainers shall be requalified at least once every two years, or sooner if significant changes occur in processes, SOPs, or regulations.
• Records of trainer qualification and requalification shall be maintained by the Training/QA Department.

Retention policy for training records:

• All training records, including training needs assessments, training calendars, training matrices, attendance sheets, evaluation results, feedback forms, OJT checklists, and trainer qualification records, shall be considered controlled quality records.
• Training records shall be retained for not less than the duration of the product life cycle to which they relate plus 1 year.
• Records shall be stored in a secure, controlled, and retrievable manner with restricted access to authorized personnel only.

 Training frequency and Applicability:

• All training programs shall be conducted for the employees listed in the table below, in accordance with the defined applicability and prescribed frequency.
• All training programs shall be completed within the specified timelines and assessed in accordance with the defined effectiveness criteria.
• All training activities shall be documented, signed, and maintained as controlled records to ensure traceability, accountability, and regulatory compliance.
• Training may be conducted earlier than the scheduled frequency if there is a revision of SOPs, introduction of new documents, regulatory updates, or any process change that impacts employee responsibilities.

REFERENCES:

• EU GMP Part I, Chapter 2: Personnel
• EU GMP Part I, Chapter 4: Documentation
• EU GMP Annex 1: Manufacture of Sterile Medicinal Products (latest version)
• ICH Q10: Pharmaceutical Quality System
• WHO TRS guideline

RECORDS:

 REVISION HISTORY.