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All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.3.21 Personnel should wear clean clothing suitable for the manufacturing activity with which they are involved and this clothing should be changed when appropriate.
Additional protective apparel, such as head, face, hand, and arm coverings, should be worn when necessary, to protect intermediates and APIs from contamination.
The workshop in which the information is shared is highly participatory and draws from the experience and knowledge of participants.
Worker should also be trained to cover coughs and sneezes to prevent contamination and spread of the illness.
Any person with sores, wounds, boils, lacerations, skin infections, burns, abrasions, or lesions should not come into indirect or direct contact with raw materials, parts, components, assemblies, finished goods, tooling, molds, fixtures, gages, machines, or equipment to prevent contamination.
A process flow diagram is a good way to help analyze where potential sources of contamination or cross-contamination can affect the safety and quality of medicinal products. Once a process flow diagram has been constructed, the HACCP plan can be developed for each step in the process.
For the purpose of this article, we will strictly focus on sources of contamination (biological, chemical, physical, and radiological) related to personnel hygiene.
Workers with sores, wounds, boils, lacerations, skin infections, burns, abrasions, or lesions should appropriately cover them.