as per who gmp guideline,who gmp
Risk of worker exposure to steroids can be greatly reduced through appropriate facility design and equipment selection. The following general recommendations will help to minimize worker exposure:
Facilities for hormonal contraceptive manufacture should be isolated from production of other products and should have separate air supply and exhaust systems. These facilities should be dedicated to hormonal contraceptive production (i.e., no other products should be made using the same facilities). Local exhaust hoods should be installed in high risk areas. High efficiency particulate air filters should be used to minimize the level of steroid particles in the air. No production area should be open to the outside.
Within OC production facilities, areas in which steroids are handled or processed should be maintained at negative air pressure and separated from other areas by air locks. Areas of high particle generation should have air pressure alarm systems that will sound and flash lights when pressure imbalances occur that could place workers at risk of steroid exposure. Locker rooms should be designed so that employees must pass through a shower room when exiting production areas.
Where possible, factories should use equipment that facilitates closed system transfers of raw and intermediate materials or eliminates transfer steps. For example, fluid bed dryers should be used for OC granulation and drying, thus eliminating the need to transfer the steroid-containing mixture to drying racks and ovens. For injectable contraceptives, pre-mixing steroids with the injection vehicle reduces the amount of particulate matter during final bulk preparation.
Dust collectors should be used to reduce steroid dust following dust-generating processes. For example, in OC production, tablet dedusters should be used following tablet compression. Steroid dust collected in these systems should be disposed of properly.
Recommended operating procedures to ensure worker protection
The following operating procedures are recommended as minimum requirements for hormonal contraceptive manufacturing:
All employees involved in the processing or testing of steroids should use individual protective equipment. Such equipment includes washable coveralls, shoes, rubber gloves, and air purifying respirators. During jobs with the greatest potential for exposure (sampling or weighing of steroids, mixing, granulation, drying tablet compression, and coating), operators also should wear air-fed suits.
All protective equipment should be intact (free of holes or tears) and worn only in designated areas. Written procedures should specify the protective equipment required for each production task.
When leaving steroid areas for breaks or meals, employees should be required to pass through an air shower into locker rooms, remove coveralls and other protective equipment, and wash their hands and faces.
At the end of the shift, employees working in steroid areas should be required to take soap and water showers before changing into street clothes.
In areas of highest potential for exposure to steroids, airborne particle counters should be used routinely to check the efficiency of air handling systems.
Employees working in areas with a potentially high risk of steroid exposure should be regularly rotated to other lower risk job assignments. Some pharmaceutical manufacturers limit shifts with potential high steroid exposure to one week out of every two while others limit exposure to one day a week (Anastas, 1984).
All employees should receive adequate information about the risks associated with hormonal contraceptive manufacture and training in risk reduction. Refresher training should be given on a regular basis to help ensure that employees understand and use safe work practices.
Separate units for laundry and waste treatment (for liquids and solids, including disposable protective equipment and filters) must be provided.
Implementing these protective measures requires rigorous training for both factory workers and management.
All personnel directly involved in hormonal contraceptive production should undergo health examinations prior to and during employment. Particular attention should be paid to the breasts and genitals during the physical examination. The company should provide, or pay for, annual pelvic examinations for female employees, including a Papanicolau smear. Routine screening examinations of workers exposed to estrogen should be done every four to eight weeks. These should include questions about estrogen related symptoms (breast tenderness, libido change, etc.) and an examination of the breast and axillary nodes. Employees with symptoms of steroid exposure should be rotated to non-production jobs and referred for further medical care. In addition, an investigation into the possible causes of steroid exposure should be conducted and changes in operating procedures or worker practices made as appropriate.
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