Personal hygiene in GMP: Dr Shikha Kumar, M Pharm, PhD

A person regularly works in the production area of a pharmaceutical company, but today he is not allowed to work there as he has an open lesion in his arm. He informed to his supervisor regarding his injury and he shifted him to other area where GMP is not practiced. So, what was wrong with him? Why he was not permitted to work in GMP area? What does GMP include and why it is important to follow?

GMP (Good Manufacturing Practice) is a part of a quality system which covers manufacturing and testing of active pharmaceutical ingredients, pharmaceutical dosage forms or drugs, diagnostics, foods, pharmaceutical products, and medical devices. GMP ensures that products are produced consistently and controlled as per the quality standards appropriate to their intended use and as required by the marketing authorization.

Personal hygiene is very important aspect of GMP. All personnel working in the production area are expected to maintain a high degree of personal cleanliness. Physical hygiene includes the human hazards and hygiene, head-hair, nose, mouth, eyes, ears, makeup, cosmetics and jewelry, coverings and clothing and gloves. Here listed the few Do’s and Don’ts of GMP with respect to personal hygiene:

• Medical examination: Every employee must undergo medical examination including eye examination especially for those who are responsible for visual inspection of drug products. All employees working under GMP must be free from tuberculosis, skin and other communicable or contagious disease and must have medical examination at least once a year and their records should be maintained properly. Employees should be trained in practices which ensure personal hygiene. If there is any apparent illness or open lesions, supervisors must be informed immediately and person should not be allowed to handle starting material, packaging material, in-process materials or drug products as it may cause the microbial contamination in drug product.

• Direct contact should be avoided between operator’s hand and starting material, primary packaging materials and intermediate or bulk product.

• To ensure the protection of the product from contamination, personnel should wear clean body coverings appropriate to the duties they perform, including appropriate hair covering. The protective clothing must be changed daily and when necessary within a day. All soiled laundry must be placed in the receptacles provided and should not be left in the production area.

• Nails should be clean and trimmed and use of nail polish is prohibited in the production area as it may flake off and contaminate the product. Persons working in production area must wear the protective hair net and no hair should be exposed or protrude from under a hair net. Men with mustaches and beard must cover them fully with beard net. Jwelery, including watches are not allowed and must be removed before entering the plant.

• Hands must be free of any lesions, wounds, cuts, boils, or any other sources of infection. Hands must be washed with soap before starting work, after break time, after lunch, after using washroom, after blowing nose, after handling garbage or whenever your hands become contaminated. Wash hands before putting a new pair of gloves and change gloves at every break, when torn or after touching garbage and after touching your face and blowing nose. All used gloves must be disposed in the garbage cans provided.

• Smoking, eating, drinking, chewing and keeping plants, food, drink, smoking material and personal medicines should not be permitted in production, laboratory and storage areas.

Personal hygiene procedures including the use of protective clothing should apply to all persons entering production areas, whether they are temporary or full-time employees or non-employees, e.g. contractors’ employees, visitors, senior managers and inspectors.

Posted by Placement Manager IGMPI

Telephone: +91 8130749005.