SOP Title: Clothing, Hygiene and Entry of Personnel
- Objective:
To lay down formal guideline for clothing, hygiene and entry of personnel at the site.
- Scope:
This procedure is applicable to all personnel working at the site and visitors visiting the facility.
- Responsibility:
All Departments: To follow the procedure in the facility and cooperate in maintaining cleanliness and hygiene.
HR/Administration Department: To ensure that the procedure is followed meticulously and provide necessary arrangements.
QA Department: To set the procedure and ensure compliance of the procedure in the site.
- Accountability:
Head HR/ Administration and QA Department
- Procedure:
5.1 Definitions:
Clothing: Includes all sorts of apparel worn or to be worn by personnel working in the site as per the requirements of the activity/department for GMP compliance.
Hygiene: Includes health maintenance or system of principles for preservation of health, prevention of disease, sanitary practices and thereby prevention of contamination in the site.
5.2 Procedure:
| 5.2.1 | All personnel entering the site shall be guided and trained to follow the clothing practice to maintain hygiene. | |
| 5.2.2 | The following basic requirements shall be provided necessarily to follow the procedure:
· Clean dresses and foot wear (area specific). · Facilities to keep their belongings (lockers). · Facilities for washing and drying. · Facilities for disinfection of hands. · Facility for keeping food material in the canteen. · Facilities for wearing specific equipment (PPE) wherever required. |
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| 5.2.3 | Personnel Hygiene | |
| 5.2.3.1 | Following instructions shall be followed strictly in the site as prime responsibility:
· Keep hairs short and clean. · Keep their nails trimmed. · Keep beard shaved. · In case of disease or illness inform the Concern Head and resume duty after medical fitness certification. · Do not spread the things at working area; use waste bin provided. · Drinking, chewing, smoking and eating inside facility are strictly. prohibited. · Don’t use any cosmetics while working in the Production, QC and Warehouse area. |
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| 5.2.4 | Clothing and Entry
Following clothing system shall be followed for clothing inside the premise: |
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| 5.2.4.1 | Primary Gowning | |
| 5.2.4.1.1 | White colour lab coat, trouser shall be worn for QC personnel. | |
| 5.2.4.1.2 | White colour lab coat, trouser, cap and mask shall be worn by Production, QA and Warehouse personnel. | |
| 5.2.4.1.3 | Blue colour lab coat, trouser, cap and mask shall be worn by Engineering personnel. | |
| 5.2.4.1.4 | White colour lab coat, trouser, cap and mask shall be worn by Visitors or Disposable Gowning may be provided. | |
| 5.2.4.1.5 | Green colour lab coat, trouser, cap and mask shall be worn by Housekeeping personnel. | |
| 5.2.4.1.6 | All the primary gowning shall be provided in the respective general change rooms. | |
| 5.2.4.1.7 | Procedure for entry and exit shall be followed as per QA SOP. | |
| 5.2.4.2 | Foot wares | |
| 5.2.4.2.1 | Black colour safety shoes shall be used by all QC and Engineering personnel. White colour rubber shoes shall be used by all Production and Warehouse personnel in core area. Street shoes shall be used outside the general/primary change room during tea time, lunch time or other departmental work movements. The shoes shall be provided in the respective general change rooms. | |
| 5.2.4.2.2 | Visitor shall be guided to wear specified shoe covers while entering QC, Production or Warehouse Departments through general change rooms. | |
| 5.2.4.3 | Entry | |
| 5.2.4.3.1 | All the critical areas in the site shall be provided with restricted entry (access to authorised personnel only). | |
| 5.2.4.3.2 | Current approved procedure shall be followed for entry/exit to these areas. | |
| 5.2.4.3.3 | Visitors shall be accompanied and guided by the Concerned Department Head or QA Head for entry to the critical areas. | |
- Abbreviation:
| SOP | Standard Operating Procedure |
| PPE | Personnel Protective Equipment |
| i.e. | Id Est (that is) |
| QA | Quality Assurance |
| QC | Quality Control |
*Note – Ready to use SOP available in “DOWNLOAD” Section.