SOP on Personnel Hygiene in Pharmaceutical Industry

SOP on Personnel Hygiene

Title: Maintain personnel Hygiene in manufacturing site:

Objective:
To maintain personnel Hygiene to prevent the contamination this may impact the quality of
the product

Scope: This procedure is applicable for all the concerned working in manufacturing Plant.

Responsibility:
All Employees: To maintain health and hygiene in manufacturing area.
Head of Department:
To check personnel Hygiene of the person working in manufacturing site
Head QA: To verify the SOP is properly followed or not.

Procedure :
- All personnel, prior to and during employment, as appropriate, should undergo health
examinations.
-Personnel conducting visual inspections should also undergo periodic eye examinations.
- All personnel should be trained in the practices of personal hygiene.

-Employee suffering from any kind of sickness should inform Plant In-charge

-Any person shown at any time to have an apparent illness or open lesions that may
adversely affect the quality of products should not be allowed to handle starting materials,
packaging materials, in-process materials or drug products until the condition is no longer
judged to be a risk.
- Personnel shall wear clean clothing suitable for the manufacturing activity.
- Direct contact should be avoided between the operator’s hands and starting materials,
primary packaging materials and intermediate or bulk product.
- Hair shall be kept clean and trimmed.

- Nails must be trimmed and shall be kept clean.

-Jewellery shall be removed for personnel engaged in manufacturing or related activities.

Use of cosmetic shall be restricted.

- Smoking, eating, drinking, chewing, and keeping plants, food, drink, smoking material and
personal medicines should not be permitted in production, laboratory and storage areas, or in
any other areas where they might adversely influence product quality.