Standard Operating Procedure for pre-employment and periodic medical check-up of employees in pharmaceutical industry

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1. Purpose

To provide a standard operating procedure for pre-employment and periodic medical check-up of employees in pharmaceutical industry.

2. Scope

The scope of this SOP is applicable for pre-employment and periodic medical check-up of employees at [company name].

3. Responsibility

HR & Administration department:

● To arrange pre-employment and periodic medical check-up of employees.

● To schedule and track periodic medical check-up of employees and inform to all the departments to attain the periodic medical check-up.

● To communicate employee to visit medical officer in case medical officer requires any consultation based on results of medical check-up.

Department head:

● To inform and send employee for periodic medical check-up to medical center.

4. Definitions

Not Applicable

5. Procedure

5.1 Pre-Employment medical check-up:

● After successful interview and selection process, before offering the employment to any candidate, pre-employment medical checkup to be done by company’s authorized medical practitioner.

● Once medical checkup found successful in accordance with company’s requirement.

● The medical checkup should consist of following tests but not limited to;

Test	Objective of test
General Physical Examination	General physical condition, height, weight for information to support other diagnosis as needed
Blood Group	For information and can be used in case of emergency condition
Urine Sugar and Albumin	To determine medical condition such as diabetes
Contagious or infectious diseases	To understand if there is any condition which could spread infection in the factory premises to other staff
Skin disease	To understand if there is any skin disease which could spread infection in the factory premises to other staff
Hemogram Report	Hemogram comprises of complete blood count (CBC) and erythrocyte sedimentation rate (ESR). A complete blood count (CBC) is a group of tests that are used to evaluate the overall health of the body. It helps in detecting a wide range of disorders such as anemia, infection, and leukemia.
X-Ray	The X-ray is done for posteroanterior (PA) chest view examines the lungs, bony thoracic cavity, mediastinum and great vessels.   The PA view is frequently used to aid in diagnosing a range of acute and chronic conditions involving all organs of the thoracic cavity.
Pulmonary function testing/ Lung Function Test	Pulmonary function testing is a complete evaluation of the respiratory system including patient history, physical examinations, and tests of pulmonary function. The primary purpose of pulmonary function testing is to identify the severity of pulmonary impairment.
Eye checkup for vision clarity	Nearsightedness: Nearsighted means that you can see well up close, but things at a distance appear blurry. Farsightedness: Farsighted means you can see well at a distance, but things up close are blurry. Astigmatism: Astigmatism means your eye is not round, and instead is shaped like a football. This visual distortion can produce shadows, double images, or ghosting. Presbyopia: Between the ages of 40-50 people start to have difficulty with reading vision.
Eye checkup for color Blindness Test	A reduced ability to distinguish between certain colours.
Audiometry Test	An audiometry exam tests your ability to hear sounds.

5.2 Periodic medical check-up:

● The objective of periodic medical check-up is to ensure the health condition of employee, any precautionary steps needs to be taken or any corrective action is required to ensure fitness of employee in order to ensure the product quality where these employees are involved in product handling.

● One of the objectives is to ensure that while handling the material to produce the pharmaceutical product. There are risk factors involved during handling of certain materials such as high potent chemical, carcinogenic material, hormones, etc. To ensure the safety of employee and to verify any development of any medical condition while handling such material, the medical examination is being done.

● Periodic medical checkup shall be done as per predefined frequency.

● Schedule of periodic check-up shall be designed in such a way that every employee will not require to carryout medical check-up in same month.

● In case of any employee is not on duty because of any reason, it shall be recorded and as soon as employee resume the duty, periodic medical check-up should be completed. Subsequent medical checkup shall be done as per schedule.

● For periodic medical checkup, HR department shall prepare a list of employee due for medical checkup and circulate to the department heads before 15 days.

● List of employee shall also be displayed on department as well as general notice board.

● Once the medical examination is completed, doctor shall forward reports of medical check-up to HR.

● In case doctor’s analysis found with any abnormality and propose further consultation, the information shall be shared to HR department. HR will send the employee to doctor for further consultation. The consultation may be for remediation of situation or precautionary to prevent any medical condition.

● In case any findings need further expert opinion, doctor shall refer to employee for the same.

● In case of any condition which man require further assessment of product quality, quality assurance department shall be involved to carryout risk assessment with respect to product quality (if employee is directly involved in the manufacturing of product) which is distributed to the market to ensure patient safety.

● Impact of specific employee needs to be extrapolated to other primary contact employees and medical examination needs to be carried out for those employees. Employee shall be advised to get consultation of other family members with doctor.

● Once the medical reports received, it shall be verified and signed by HR department.

5.3 Specific medical examination for specific types of operations:

Eye test and color blindness test:  For workers who involve in inspection process, testing process, and process where color change needs to be detected by employee as part of job responsibility.

Sensitizing antibiotic/ Penicillin allergy skin test: Workers who needs to involve in Sensitizing antibiotic/ Penicillin manufacturing.

Audiometry test: For employees who are exposed to High Noise Areas on annual basis. 

Other specific test: In case of manufacturing operation many cause any specific type of side effect, depending on severity and likelihood of occurrence, periodic assessment frequency should be decided in consultation with medical officer so as to ensure employee safety.

6. Frequency

Test	Pre-employment	Yearly	Six monthly	Other
General Physical Examination	Yes	Yes	—-	—-
Blood Group	Yes	—-	—-	—-
Urine Sugar and Albumin	Yes	Yes	—-	—-
Contagious or infectious diseases	Yes	Yes	—-	—-
Skin disease	Yes	Yes	—-	—-
Hemogram Report	Yes	Yes	—-	—-
X-Ray	Yes	—-	—-	Based on doctors periodic assessment and based on lung functional test
Pulmonary function testing/ Lung Function Test	Yes	—-	—-	—-
Eye checkup for vision clarity	Yes	—-	Yes (For visual inspectors)	—-
Eye checkup for color Blindness Test	Yes	—-	Yes (For visual inspectors)	—-
Audiometry Test	Yes	Yes (For employees who are exposed to High Noise Areas on annual basis.)	—-	—-
Sensitizing antibiotic/ Penicillin allergy skin test	Yes	—-	—-	—-
Other specific test	Yes (Depending on types of operation)	Yes (Depending on types of operation)	Yes (Depending on types of operation)	—-

7. Formats

● Format for list of employees for medical examination

Periodic medical examination for the year:

Sr. No.	Name of Employee	Month of periodic examination	Department

● Format of intimation of specific test (other than annual frequency)

Periodic medical examination for the year:

Sr. No.	Name of Employee	Month of periodic examination	Test name	Department

● Format for medical examination reporting

(Following are general guidance, final decision and correctness of the requirement should be done in consultation with medical professional)

A. General Information:

a. Name of Employee:

b. Employee Id.:

c. Age:

d. Gender:

e. Date of Joining:

f. Department:

g. Designation:

h. Blood Group:

i. Marital Status:

j. Habit (Tobacco products, alcohol, etc.):

B. Medical history:

a. Operations:

b. Any other medical condition:

c. Family history for any specific illness:

C. Skin disease/ Contagious diseases:

a. Yes/ No:

b. Specify:

D. General Examination:

a. Height:

b. Built:

c. Weight:

d. BMI:

e. Hair:

f. Skin:

g. Ear:

h. Eyes:

i. Spectacles:        Right eye:          Left eye:

j. Distant Vision:

k. Near vision:

l. Color Vision:

m. Nose:

n. Throat:

o. Fundus:

p. Teeth:

q. Pharynx:

r. Peripheral nervous system:

s. Lymph Nodes:

t. Speech:

u. Oro-dental hygiene:

v. Tonsils:

w. Neck:

x. Personal hygiene:

y. Other findings:

E. Respiratory System

a. Respiratory Rate:

b. Breathe sounds:

c. Rales:

d. Ronchi:

e. Chest shape:

f. X –Ray result:

g. Lung function tests:

F. Abdomen:

a. Shape:

b. Umbilicus:

c. Operation scar:

d. Veins:

e. Free fluid:

f. Liver:

g. Spleen:

h. Kidneys:

i. Peristalsis:

j. Tenderness:

k. Guarding:

G. Cardio-Vascular System

a. Pulse:

b. Blood pressure:

c. Oedema:

d. Cyanosis:

e. Clubbing:

f. Peripheral Pulses:

g. Heart Sounds:

h. Electro cardiogram:

H. Genitourinary System

a. External Genitals:

b. Hernia:

c. Signs of Sexually transmitted diseases (STDs):

d. Hydrocoele:

e. Testis and epididymis:

f. Urethral discharge:

I. Nervous System:

a. Higher functions:

b. Behavior:

c. Peripheral nerves:

d. Greater Auriculars:

e. Ulners:

f. Reflexes:

g. Other findings:

J. Skin

a. Hypo-pigmented Patches:

b. Skin disease:

K.  Locomotor:

a. Muscles & Joints:

b. Movements:

L.  Investigations done:

M. Investigation advised (If any):

N. Concluding Remark: