Sanitation and Hygiene <ul><li>Personnel Hygiene – I </li></ul><ul><li>Health examinations </li></ul><ul><ul><li>On recrui...
Sanitation and Hygiene <ul><li>Personnel Hygiene – II </li></ul><ul><li>Illness </li></ul><ul><ul><li>staff with illness o...
Sanitation and Hygiene <ul><li>Personnel Hygiene – III </li></ul><ul><li>Contact between product and operator </li></ul><u...
Sanitation and Hygiene <ul><li>Personnel Hygiene – IV </li></ul><ul><li>Clothing and changing facilities  </li></ul><ul><u...
Sanitation and Hygiene <ul><li>Personnel Hygiene – V </li></ul><ul><li>Smoking, eating and drinking should not be allowed ...
Sanitation and Hygiene <ul><li>Group Session - Option 1 </li></ul><ul><li>Look at the photographs in the handout and recor...
Sanitation and Hygiene <ul><li>Group Session - Option 2 </li></ul><ul><li>You are inspecting a new factory. What are the k...
Sanitation and Hygiene  <ul><li>Possible Issues  – I </li></ul><ul><li>Sanitation </li></ul><ul><li>Mixed production </li>...
Sanitation and Hygiene <ul><li>Possible Issues  – II </li></ul><ul><li>Hygiene </li></ul><ul><li>Personal hygiene </li></u...
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Personnel Hygiene Group Session

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  • Having dealt with sanitation, we now move on to the hygiene of the personnel involved in manufacturing. This is covered in the WHO GMP texts in part one, section 10. The recruitment process for direct operators in particular should include a medical examination. This should be repeated on a regular basis during the employment period. The definition of “regular” will obviously depend on the activities being undertaken and the products being processed. Induction training for new operators should include basic training in personal hygiene and should state the level of hygiene that is required for working in manufacturing areas. There should be written procedures covering the need to wash hands before entering a manufacturing area. In addition, signs should be posted in the changing rooms to reinforce this. Staff who have an illness or open lesions that are likely to present a risk to the product, should not be allowed to carry out operations that involve handling of starting materials, intermediates or finished products until the condition has cleared up. Since not all illnesses are going to be obvious, operators must be trained to recognize such risks themselves and be willing to report any illness to the area supervisor.
  • Personnel Hygiene Group Session

    1. 1. Sanitation and Hygiene <ul><li>Personnel Hygiene – I </li></ul><ul><li>Health examinations </li></ul><ul><ul><li>On recruitment for direct operators , repeated on regular basis </li></ul></ul><ul><li>Training - check </li></ul><ul><ul><li>induction training for new operators includes basic personal hygiene training </li></ul></ul><ul><ul><li>written procedures - to wash hands before entering a manufacturing area </li></ul></ul><ul><ul><li>signs in changing rooms to reinforce hand washing </li></ul></ul>Part One 10.16 – 10.23
    2. 2. Sanitation and Hygiene <ul><li>Personnel Hygiene – II </li></ul><ul><li>Illness </li></ul><ul><ul><li>staff with illness or open lesions should not handle starting materials, intermediates or finished products </li></ul></ul><ul><li>Adverse conditions </li></ul><ul><ul><li>operators trained to recognize risks </li></ul></ul><ul><ul><li>willingness to report illness to the area supervisor </li></ul></ul>Part One 10.16 – 10.23
    3. 3. Sanitation and Hygiene <ul><li>Personnel Hygiene – III </li></ul><ul><li>Contact between product and operator </li></ul><ul><ul><li>avoid direct contact </li></ul></ul><ul><ul><li>if direct handling unavoidable, gloves should be worn </li></ul></ul><ul><ul><li>check glove disinfection (for sterile production) and disposal </li></ul></ul>Part One 10.20 – 10.23, 11.7 – 11.8
    4. 4. Sanitation and Hygiene <ul><li>Personnel Hygiene – IV </li></ul><ul><li>Clothing and changing facilities </li></ul><ul><ul><li>check changing rooms (handwashing, towels or hot air hand dryers) </li></ul></ul><ul><ul><li>check if used clothing stored in separate closed containers while awaiting cleaning </li></ul></ul><ul><ul><li>laundering of clean area clothing must be to SOP and in appropriate facility </li></ul></ul><ul><ul><li>check for procedure for sterilizing and storing clothing for use in sterile area </li></ul></ul>Part One 10.20 – 10.23, 11.7 – 11.8
    5. 5. Sanitation and Hygiene <ul><li>Personnel Hygiene – V </li></ul><ul><li>Smoking, eating and drinking should not be allowed in any manufacturing area, including laboratories and storage rooms. </li></ul><ul><li>Chewing of gum should be banned. </li></ul><ul><li>There should be no plants kept inside any factory areas. </li></ul><ul><li>Rest and refreshment areas should be separate from manufacturing areas. </li></ul><ul><li>Toilets should not open directly into production or storage areas. </li></ul>Part One 10.20 – 10.23, 11.7 – 11.8
    6. 6. Sanitation and Hygiene <ul><li>Group Session - Option 1 </li></ul><ul><li>Look at the photographs in the handout and record </li></ul><ul><li>as many sanitation and hygiene issues as you can </li></ul>
    7. 7. Sanitation and Hygiene <ul><li>Group Session - Option 2 </li></ul><ul><li>You are inspecting a new factory. What are the key issues for sanitation and the key issues for personnel hygiene that the company should have in place? </li></ul>
    8. 8. Sanitation and Hygiene <ul><li>Possible Issues – I </li></ul><ul><li>Sanitation </li></ul><ul><li>Mixed production </li></ul><ul><li>Penicillins </li></ul><ul><li>Product versus batch changeovers </li></ul><ul><li>Water systems </li></ul><ul><li>How long should a “cleaned” status last for? </li></ul><ul><li>What should happen if a clearance check is required when no QC personnel are on duty? </li></ul><ul><li>Procedures and records </li></ul>
    9. 9. Sanitation and Hygiene <ul><li>Possible Issues – II </li></ul><ul><li>Hygiene </li></ul><ul><li>Personal hygiene </li></ul><ul><li>Health checks </li></ul><ul><li>Dealing with health problems </li></ul><ul><li>Personal responsibility </li></ul><ul><li>Training records </li></ul><ul><li>Frequency of handwashing </li></ul>

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