GMP & Handwashing

21CFR 211.28 Personnel responsibilities.[b][COLOR=“blue”]

(a) Personnel engaged in the manufacture, processing,packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective
apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

(b) Personnel shall practice good sanitation and health habits.

© Only personnel authorized by supervisory personnel shall enter those areas of the buildings and facilities designated as limited-access areas.

(d) Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with
components, drug product containers, closures, inprocess materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed
to report to supervisory personnel any health conditions that may have an adverse effect on drug products. "[/color][/b]

In addition to the concern over the quality of our validation studies, there is a personnel consideration as well. Proper hand washing technique is the most effective means to slow the spread of disease in our facilities which is particularly important in this time of increased concern over global pandemic.

Some of hand washing guidelines are: ASTM- E1174-00 Standard Test Method for Evaluation of the Effectiveness of Health Care Personnel or Consumer Hand wash Formulations,or the two European standards prEN 12054 (describing suspension tests) and prEN 12791 (describing the in vivo test).

CGMP for basic requirements:

“211.52 Washing and toilet facilities. Adequate washing facilities shall be provided, including hot and cold water, soap or detergent, air driers or single -service towels, and clean toilet facilities easily accessible to working areas.”

Some aspects of the availability of soap and water (interms of sinks) are self-evident. First of all, there should be soap and water available to those entering and leavingthe lab or manufacturing area. The water should be of sufficient quality (at least potable). The mechanism to operate the water flow should not encourage the recontamination of the hands immediately after washing.

The type of soap, and in particular the design of the soap dispenser, is another important aspect of the efficacy of handwashing. We have three major choices: bar soap, refillable liquid soap and sealed liquid soap . Bar soap is not suitable as it is a proven reservoir for bacteria . This leaves us with liquid soap.

Liquid soap dispensers come in two general designs.In the first, liquid soap can be added to a reservoir when required. Best practice is to completely clean out this reservoir before filling it again to prevent bacterial buildup as bacteria can live in soap.

The other variety of public area liquid soap dispenser has a sealed bag with an integral nozzle. Regardless of the formulation contained within the bag, at least with this set up you are starting clean at each refill.