SOP on Personal hygiene in pharmaceutical industry

This Document describes (Standard Operating procedure) SOP on Personal hygiene in pharmaceutical industry

SOP on Personal hygiene in pharmaceutical industry

I. Purpose & Scope:

• Drugs are manufactured under stringent controlled conditions and hence personal hygiene of employees is of at most importance in Pharma industry. Every individual involved in process of production is to comply with Specific norms for maintaining  personal health & clean and hygienic habits.
• The requirements stipulated for personal hygiene are applicable to all the employees as well as visitors. Strict compliance must be ensured to eliminate ‘Human Factor’ for being the cause of adverse quality of product.

II. Responsibilities:

• All employee shall be responsible for implementation of Personal hygiene SOP
• Administration Department shall be responsible for Providing the necessary facilities and informing visitors about the practices to be followed on Personal hygiene.
• Head Quality assurance shall be responsible for implementation & overall monitoring of the procedure.

III : Introduction and Procedural Part:

General requirements for Personal hygiene in pharmaceutical industry :

Following are the minimum requirement for every person entering company area.

• Every new recruited company employee shall go through pre-employment medical checkup.
• Other than the pre-employment medical checkup every company employees shall appear for yearly medical check-up conducted by the doctor from time to time.
• Special attention to be paid to persons with any contagious or / and communicable disease.
• An employee suffering from an infection, disease like conjunctivitis, severe cold, etc. shall not be allowed to enter in production area.
• An employee shall report any infection due to enteric disorders or respiratory diseases so that they can be temporarily transferred to other non-critical areas.
• Each employee shall report any boils, open wounds, cuts, and rashes on exposed surfaces of body, such employees will not be allowed to work in operation involving direct material or equipment contact until the conditions of him / her is rectified.
• Every supervisor or departmental head will look for such signs or symptoms and report to head of HR department immediately.
• If the person worked in direct contact of the product immediately change to his work place.

Personal cleanliness:

• All employees shall maintain personal cleanliness.
• All personnel working in factory shall be instructed to have daily bath, wear clean garments.
• All employees shall keep their hands clean and wash with liquid soap soon after visiting toilet or urinals.
• Hair shall be short and clean.
• All employee shall keep nails clean.
• All employee shall keep hair clean and cover with cap.
• All mail employees shall have clean shave on daily basis and employees keeping mustaches should have trimmed mustaches.
• All employees shall remove their wrist watches, wrist thread, rings and chain before entering into the production area.
• All male & females shall remove all types of jewelry put on body and wash make – up from the face before entering into the production areas.
• Employees shall keep teeth and mouth clean after meals and drinks.

Hygienic operations:

• All Employees shall be prohibited from smoking, tobacco chewing, alcoholism’s and pan eating habits inside the factory premises.
• All employees may surrender above items or such belongings at the security gate before entry in to the factory premises.
• All employees shall be allowed to take cooked foods, soft drinks and fruits and other eatables up to canteen area only.
• Employees shall deposit above items at an appropriate place in the pantry house (canteen area).
• All employees shall not touch walls or doors when their hands are dirty or spoiled.
• All employees shall keep change room clean to the highest level of GMP & satisfaction of management.
• All employees shall always keep waste piece of papers inside the waste bins.
• All employees shall keep lockers neat and clean and in tidy conditions. They should not keep any eatable inside lockers or pockets of clothes.
• Every employee and contract person shall extend his or her full support to security and Human resources person for checking whenever required.
• All employees shall make best and appropriate use of toilets and change room facilities in order to maintain highest level of healthy environment.
• All employees shall always follow the general / safety instruction written and / or displayed in premises.

Protective clothing:

• No employee shall enter in the Production area and other areas like Store, Quality control etc. without wearing appropriate protective clothing.
• All employees shall make appropriate use of company issued uniforms and personal protective equipment such as head cover, nose mask and shoe cover, whenever required.
• All the workers and staff at work place shall wear clean factory uniform. In production areas where persons are directly exposed to the products, they shall wear proper gowning.
• Clean footwear shall be provided in change rooms to go in production area.
• Separate change rooms shall be provided for male & female employee & visitors for gowning & de-gowning.
• All employees shall follow safety precautions while handling solvent / chemicals.

ANNEXURE – I

PERSONAL HYGIENE CHECKLIST

 Date:________________

Note:  Put  tick on particular column of Checkpoints.

Checked By :                                                                                                                                                                             Reviewed By :