OBJECTIVE:

• To lay down the procedure for personnel Hygiene and Medical Checkup of all employees of the Company.

SCOPE:

• This SOP applies to all employees, contractors, trainees, and temporary staff working within the organization, including production, warehouse, quality control, quality assurance, engineering, microbiology, administration, and support functions.

RESPONSIBILITIES:

Human Resource Department (HR):

• Coordinate pre-employment, periodic, and return-to-work medical examinations.
• Schedule medical check-ups with approved hospitals/clinics or Doctors.
• Maintain employee medical records securely and confidentially.
• Ensure only medically fit personnel are considered for employment or assignment to critical areas.
• Liaise with the authorized medical service provider for required tests.
• Ensure availability of required forms, fitness certificates, and check-up formats.

Department Heads / Line Managers:

• Ensure their team members undergo medical check-ups as per schedule.
• Restrict employees from working in GMP areas if overdue or medically unfit.
• Support HR in rescheduling or follow-up in case of missed health checks.

Employees:

• Attend scheduled medical examinations without delay.

Approved Medical Practitioner / Hospital:

• Conduct medical examinations as per agreed checklist and occupational health requirements.
• Provide objective, unbiased medical fitness certificates.
• Maintain confidentiality of medical information.
• Notify HR of fitness status (Fit / Fit with Restrictions / Temporarily Unfit).

Quality Assurance (QA):

• Ensure the SOP is implemented and followed in alignment with GMP requirements.
• Review and approve the list of approved medical service providers.

 DEFINATIONS:

• Medical Check-Up: A systematic health examination conducted to assess an employee’s physical and mental fitness for work.
•  Pre-Employment Medical Examination: A medical assessment performed before hiring to confirm that the candidate is medically fit for the intended job role.
• Periodic Medical Examination: A scheduled health check-up conducted at defined intervals (annually) to monitor the ongoing fitness of employees.

PROCEDURE:

• The Personnel Department and respective Department Heads shall ensure that all employees undergo periodic medical check-ups as defined in this SOP.
• A pre-employment medical fitness certificate shall be submitted to the Personnel Department for all newly recruited employees before joining.
• An annual medical examination shall be conducted for all employees as per the predetermined schedule.
• All plant personnel shall undergo a yearly medical check-up conducted by an approved external Medical Officer, which includes a general health assessment, eye examination, and tuberculosis screening as per Format.
• All medical reports shall be maintained as permanent records by the QA Department for the duration of the employee’s service and for an additional five years after separation from the company.
• If any operator or employee becomes ill during working hours, the incident shall be reported to the Department In-Charge using the format provided in the format.
• Employees returning to duty after a prolonged illness, especially involving any communicable disease, shall submit a medical fitness certificate to the Personnel Department before resuming work.

REFERENCES:

• WHO Technical Report Series (TRS) 986, Annex 2 – Good Manufacturing Practices for Pharmaceutical Products.
• WHO Guidelines on Quality Risk Management – Occupational health and personnel hygiene requirements.

RECORDS:

REVISION HISTORY.