1.0 Purpose
1.1 To ensure employees are medically fit and free from any illness/injury in order to minimize the risk adversely affecting product quality and safety.
2.0 Scope
2.1 This Sop is applicable to all management & non-management staff employed by the " NAME" Pharmaceuticals Ltd, who are directly or indirectly involved with production.
3.0 Responsibility
3.1 Factory Medical Practitioner/ Doctor is responsible for medical check-up of all employees, fill-up of the Health Card.
3.2 Officer, Admin is responsible for collecting the medical examination reports in Employee File.
4.0 Abbreviations and Definitions
4.1 SOP= Standard Operating Procedure
4.2 Pre Employment Medical Fitness: Persons those are selected for employment but their medical fitness are yet to examine.
4.3 Post Employment Medical Fitness: Persons those are already employed but their periodic medical yet to be examined.
5.0 Materials and Equipment
5.1 Not Appreciable
6.0 Precaution / Health and Safety Considerations
6.1 Do not recruit the applicant for employment having detected unacceptable medical condition.
7.0 Procedure
7.1 Pre-Employment Health Check
7.1.1 Select the employee for the employment
7.1.2 Send the employee to the Factory Medical Practitioner/ Doctor for medical check-up.
7.1.3 Check thoroughly and record:
- Eye Vision
- Blood Pressure
- Pulse rate
- Skin Lesions
- Any Known allergies
- Physical ability
7.1.4 Send the employee to the selected clinic for investigation (if required).
7.1.5 Collect the examination reports from the employee confidentially.
7.1.6 Send the report to Factory Doctor for verification.
7.1.7 Fill up the Medical Check-up Report with comment and send it to the Admin Department.
7.1.8 Issue appointment letters to the employee (s) if the reports are satisfactory.
7.1.9 Advice an unfit to recover his problem within a stipulated time.
7.1.10 Send a regret letter to the employee if the identified disease is incurable.
7.1.11 Keep all the medical reports in the ‘Employee Personal File’.
7.2 Health Check during Employment
7.2.1 Health check shall be performed twice in a year for all employees who directly involved in manufacturing and Vision/Eye test every six months for personnel engaged in visual inspection.
7.2.2 Annual Health Check of the employees shall be scheduled by HRD and performed by a certified Medical practitioner.
7.2.3 Complete physical examination shall be performed and documented as per medical examination record.
7.2.4 The employees shall be referred to specialized practitioner/ Diagnostic centers if deemed necessary by the practitioner.
7.2.5 Based on findings of specialized Practitioner / Diagnostic center, the designated certified medical practitioner shall make final recommendation.
7.2.6 HRD shall maintain record of annual Health Check of employees in their personal files.
7.2.7 In case of any emergency & illness report to the factory doctor for his advise & record it on the patients register.
8.0 Reference Document
8.1 WHO Guidelines, volume 2, second edition.
9.0 Annexure
9.1 Annexure-I : Health Card
10.0 Revision History
Revision No. | Brief reason for the revision | Effective Date | Remarks |
01 | New |
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02 |
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11.0 Training
11.1 Head of Quality Assurance or his/her nominee shall give the SOP training before effective date.
