Hygiene and cleanliness programs as per USFDA GMP in pharmaceuticals
High standards of personal hygiene and cleanliness are essential. Hygiene programs should be established
Eating, drinking, chewing or smoking, as well as the storage of food or personal medication should be prohibited in the production and storage area.
Direct contact should be avoided between the operator’s hands and the exposed product as well as with any part of the equipment that comes into contact with the products.
Every person entering the manufacturing areas should wear clean clothing suitable for the manufacturing activity with which they are involved and this clothing should be changed when appropriate. Additional protective garments appropriate to the operations to be carried out (e.g. head, face, hand and/or arm coverings) should be worn when
The clothing and its quality should be appropriate for the process and the grade of the working area. It should be worn in such a way as to protect the operator and the product from the risk of contamination.
The description of clothing required for clean areas is as follows:
- Grade D: Hair and, where relevant, beard and moustache should be covered. A general protective suit and appropriate shoes or overshoes should be worn. Appropriate measures should be taken to avoid any contamination coming from outside the clean area.
- Grade C: Hair and where relevant beard and moustache should be covered. A single or two-piece trouser suit, gathered at the wrists and with high neck and appropriate shoes or overshoes should be worn. They should shed virtually no fibres or particulate matter.
- Grade A/B: Sterile headgear should totally enclose hair and, where relevant, beard and moustache; it should be tucked into the neck of the suit; a sterile face mask and sterile eye coverings should be worn to prevent the
shedding of droplets and particles. Appropriate sterilised, non-powdered rubber or plastic gloves and sterilised or disinfected footwear should be worn. Trouser-legs should be tucked inside the footwear and garment sleeves into the gloves. The protective clothing should shed virtually no fibres or particulate matter and retain particles shed by the body.
Outdoor clothing should not be brought into changing rooms leading to grade B and C rooms. For every worker in a grade A/B area, clean (sterilised) protective garments (including face masks and eye coverings ) should be provided every time there is an entry into the clean area; the need to exit and re-enter the clean area for a different
manufacturing step/different batch should be determined by the risk of the activity.
Gloves should be regularly disinfected during operations. Upon exit from a clean area there should be a visual check of the integrity of the garment.
Clean area clothing should be cleaned and handled in such a way that it does not gather additional contaminants which can later be shed. When working in a contained area,protective clothing should be discarded before leaving the contained area.
Wristwatches, make-up and jewellery should not be worn in clean areas.
Where required to minimise the risk for cross-contamination, restrictions on the movement of all personnel should be applied. In general, personnel (or any other person) should not pass directly from areas where there is exposure to live microorganisms, GMOs, toxins or animals to areas where other products, inactivated products or different organisms are handled. If such passage is unavoidable, appropriate control measures (having regard to the risks) should be applied. When a person moves from one clean room to another clean room (higher to lower grade, or lower to higher grade) appropriate disinfection measures should be applied. The garment requirements required
for the relevant grade should be respected.
Activities in clean areas, especially when aseptic operations are in progress, should be kept to a minimum. Excessive shedding of particles and organisms due to over-vigorous activity should be avoided.
Only the minimum number of personnel should be present in clean areas. Inspections and controls should be conducted outside the clean areas as far as possible.
Steps should be taken to ensure that health conditions of the personnel that may be relevant to the quality of the products are declared and that no person affected by an infectious disease which could adversely affect the quality of the product, or having open lesions on the exposed surface of the body, is involved in the manufacture of products.
Health monitoring of staff should be proportional to the risks. Where necessary having regard to the specific risks of the product, personnel engaged in production, maintenance,testing and internal controls, and animal care should be vaccinated. Other measures may need to be put in place to protect the personnel according to the known risks of the
product and of the materials used in the manufacture thereof.