Standard Operating Procedure of Personnel Hygiene in Pharmaceuticals Industires is describe in this post.
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1. Purpose:
1.1. To prevent contamination of health supplement products by employees in the manufacturing area.
2. Scope:
This standard operating procedure applies to employees who handle health supplement raw materials, packaging materials, in-process materials, and finished products in the manufacturing area of Pharmaceuticals.
3. Responsibility:
3.1. Production Manager
3.2. QA Manager
3.3. QC Manager
3.4. Department Supervisors
4. Procedure:
4.1 Grooming:
1. Arrive to work with clean hair, teeth brushed and bathed daily.
2. Maintain trimmed, filed, cleaned fingernails without rough edges. No polished fingernails and artificial nails are permitted in the manufacturing area. Daily check will be conducted and recorded in Personnel Hygiene Record Form.
3. Employees working in the manufacturing area must wash their hands properly before entering the processing area; then gloves shall be put on as required. Hands must always be washed:
• Before commencing work.
• Before wearing disposable gloves.
• Between performing different task.
• Immediately after using the toilet and returning to work station.
• After handling contaminated item or when unsanitary task hasbeen performed – i.e. taking out garbage, handling cleaning chemicals, wiping tables, picking up a dropped utensils, etc.
• After smoking, eating or drinking.
• After touching face, nose, mouth, skin, hair or other exposed body parts.
• After sneezing, coughing or nose blowing.
4. Wash hands only in designated sinks intended for the purpose. Turn off faucets in a sanitary fashion in order to prevent recontamination of clean hands.
5. Dry hands with single-use towels and dispose used towels in closed trash bin.
4.2 Proper Attire:
4.2.1 Wear clean properly secured coveralls, hair restraints and gloves at all times in the manufacturing area. Coveralls shall be sufficient to cover all personal clothing. They shall be changed daily.
4.2.2 Must not wear coveralls outside the manufacturing area. Remove coveralls, hair restraints and gloves before using toilet facilities, using lunchroom and exiting the manufacturing area.
4.2.3 Wear hair restraints at all times in the manufacturing area. All hair must be covered to prevent any possible contamination of health supplement products.
4.2.4 Employees with any facial hair (beards or mustaches) must wear beard nets.
4.2.5 Change to clean, non-skid, closed-toe work shoes that are appropriate for standing and working on manufacturing floors. Work shoes must be removed before using toilet facilities, using lunchroom and exiting the manufacturing area. Footwear must be easily cleaned and maintained in a clean condition.
4.2.6 Remove make-up, wrist watch and jewelry when entering the manufacturing area.
4.2.7 Proper attire will be checked daily and record in Form.
4.2.8 Store personal clothing and belongings in designated locker facility. Food, drinks, tobacco materials and personal medicine are not allowed to be stored in this locker facility.
4.3 Illness and lesion:
4.3.1 Employees shall not be a carrier of or diagnosed of being ill with the following communicable diseases:
Tuberculosis, Cholera, Typhoid fever, Chickenpox, Dysentery, Measles, Mumps, Leprosy, Jaundice, Red eye, Hepatitis and infectious skin diseases. Employees with these diseases must not be allowed in the manufacturing facilities and local health regulatory agency must be notified.
4.3.2 Report any flu-like symptoms, fever, diarrhea, sore throat, constant sneezing, coughing, runny nose and/or vomiting to the supervisor.
4.3.3 Employees with these symptoms will be sent home or re-assigned nonfood related duties or sick leave, whichever is most appropriate.
4.3.4 Report any lesions on the hand, wrist, or any exposed body part to supervisor.
4.3.5 Minor cut and abrasion may be properly treated and bandaged. When hands are bandaged, disposable gloves must be worn to cover the entire bandaged area before commencing work.
4.3.6 Employees with serious lesions must not be allowed to handle raw materials, packaging materials, in-process materials, and finished products until the condition is improved. Smoking, eating, and gum chewing:
1. Smoke only in designated areas. No smoking or chewing of tobacco shall occur inside manufacturing facilities.
2. Eat and drink in designated areas only.
3. Refrain from chewing gum or eating candy during work in the manufacturing area.
4.4 Monitoring:
4.4.1 A designated employee will inspect subordinate employees when they report to work daily or at appropriate interval to be sure that each employee is following this SOP. The designated employee will monitor that all subordinate employees are adhering to the personal hygiene policy during all hours of operation.
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