OBJECTIVE:

• To define the procedure for systematic induction and orientation of new employees to ensure that all personnel understand the organization’s policies, objectives, WHO GMP requirements, safety, and hygiene practices before commencing work.

SCOPE:

• This SOP applies to all newly joined employees, including permanent, temporary, contractual, and trainees at all departments of the organization.

RESPONSIBILITIES:

Human Resource (HR) Department:

• Plan and coordinate induction and orientation program.
• Prepare detailed induction schedule for each new employee.
• Maintain all induction-related records and attendance.
• Communicate company policies, welfare schemes, and code of conduct.

Department Head:

• Conduct departmental-level orientation.
• Introduce new employee to team and explain responsibilities.
• Provide overview of departmental functions, objectives, and SOPs.

 Quality Assurance (QA) Department:

• Conduct GMP before work assignment.
• Evaluate understanding and effectiveness of training.

 Safety / Engineering Officer:

• Conduct safety induction and emergency preparedness session.
• Train on use of PPE and workplace safety practices.

 New Employee:

• Attend all scheduled induction sessions.
• Follow company policies, GMP, hygiene, and safety requirements.

DEFINATIONS:

• Induction: Initial introduction of a new employee to company culture, rules, and policies.
•  Orientation: Detailed familiarization with job responsibilities, GMP systems, safety, and documentation practices.

 PROCEDURE:

Preparation:

• HR shall prepare a Joining Checklist and Induction Schedule for every new employee.
• The schedule shall include HR, QA, Safety, and Departmental sessions.
• Personal file shall be created and employee code assigned.

General Induction (HR Session):

• HR shall explain:
  • • Company history, vision, and organizational structure.
    • HR policies (attendance, leave, dress code, working hours).
    • Salary, benefits, and code of conduct.
    • Anti-harassment, confidentiality, and data protection policies.
    • Provide Employee Handbook and ID card.

 GMP and Quality Induction:

• QA shall conduct orientation on:
  • • WHO GMP principles and quality policy.
    • Documentation practices (Good Documentation Practice).
    • Personal hygiene, gowning, and entry procedures.
    • Behavior in production, QC, and warehouse areas.
    • Deviations, CAPA, and change control awareness.

  Safety and SHE Induction:

• SHE Officer shall conduct:
  • • Fire safety and emergency evacuation routes.
    • Use of PPE and first-aid awareness.
    • Safe material handling and accident reporting.

 Departmental Induction:

• Department Head shall introduce the new employee to colleagues and immediate supervisor.
•  Explain departmental workflow, SOPs, job duties, and reporting structure.
•  Ensure the employee signs Job Description .

 Record and Acknowledgement:

• After completion of all induction modules, HR shall collect acknowledgement from the employee.
•  Signed Induction Attendance Record shall be filed in the personal file.
•  QA shall verify completion of GMP training before the employee is allowed to work independently.

Document Retention:

• Induction Schedule – Shall be be retained for 3 years.
• Induction Attendance Record – To be retained for 5 years.
• Joining Checklist – To be retained for 5 years.
• Training Effectiveness Form – To be retained for 3 years.

REFERENCES:

• WHO TRS 986, Annex 2 — Good Manufacturing Practices: Personnel and Training
• ISO 9001:2015 — Clause 7.2 Competence

 RECORDS:

 REVISION HISTORY.