- OBJECTIVE:
To lay down a procedure for entry / exit & gowning / de-gowning procedure for staff, operators, workers & visitor to the plant.
- SCOPE:
This SOP is applicable for entry / exit & gowning / de-gowning procedure for staff, operators, workers & visitor to the plant at {Company Name} {Company Location}.
- RESPONSIBILITY:
Officer/executives of all departments.
HR Head shall be responsible for Review, technical correction, training & monitoring of SOP.
- ACCOUNTABILITY:
QA Head shall be accountable for Approval & Implementation of SOP.
- PROCEDURE:
- Color coding of uniform for working person in production, warehouse, Quality control, Quality Assurance, Operators, Maintenance & Housekeeping shall varies as per company to company.
NOTE:
- Slippers shall be provided for staff, operators, and workers in the change room for the plant.
- Ornaments and eatable items are not allowed in production area.
- Keep all personnel belongings in respective provided locker.
- Cell phones in production area are allowed for authorized personnel only.
- Entry & gowning procedure for gents Change Room
- Enter the door of change room & enter into gents Change Room.
- Open the locker & take company’s slipper, remove belonging and kept in locker.
- Sit & remove your street shoes/slippers .
- Sit & swing over the cross over bench.
- Bear the company provided slippers from crossover bench.
- Sanitize hands with disinfectant solution provided.
- Collect the apron & cap from dress cabinet & wear it.
- Check your outfit in mirror for proper gowning.
- Open the door & enter the plant.
Click the link for download word file copy of this document:
https://pharmaguidehub.com/product/entry-exit-gowning-de-gowning-procedure-for-staff-operators-workers-visitor-to-the-plant/
- Exit & De gowning procedure for gents Change Room:
- Open the door of change room from the plant side & enter.
- Remove the apron, cap & hang the apron in the dress cabinet.
- Remove the company provided slippers to crossover bench.
- Sit & swing over the cross over bench.
- Wear the outside slipper/shoes.
- Open the outside door of the gents Change Room to exit.
- Entry & gowning procedure for ladies Change Room:
- Enter the door of change room & enter into ladies Change Room.
- Open the locker & take company’s slipper, remove belonging and kept in locker.
- Sit & remove your street shoes/slippers.
- Sit & swing over the cross over bench.
- Bear the company provided slippers from crossover bench.
- Sanitize hands with disinfectant solution provided.
- Collect the apron & cap from dress cabinet & wear it.
- Check your outfit in mirror for proper gowning.
- Open the door & enter the plant.
- Exit & De gowning procedure for ladies Change Room
- Open the door of change room from the plant side & enter.
- Remove the apron, cap & hang the apron in the dress cabinet.
- Remove the company provided slippers to crossover bench.
- Sit & swing over the cross over bench.
- Wear the outside slipper/shoes and take belongings from locker.
- Open the outside door of ladies Change Room to exit.
- Entry & gowning procedure for visitor Change Room to the plant:
- Open the door of the visitors Change Roomand enter.
- Wear the shoe cover.
- Sit & swing over the cross over bench.
- Sanitize hands with disinfectant solution provided.
- Collect the apron & cap from the visitor dress cabinet & wear it.
- Check your outfit in the mirror for proper gowning.
- Sanitize the hands with disinfectant solution again.
- Open the door & enter the plant.
- Exit & de gowning procedure for male visitor Change Room :
Click the link for download word file copy of this document:
https://pharmaguidehub.com/product/entry-exit-gowning-de-gowning-procedure-for-staff-operators-workers-visitor-to-the-plant/
- Open the door of male visitorchange room from the plant side & enter.
- Remove the apron, cap & put it in the used dress cabinet.
- Sit & swing over the cross over bench.
- Remove the shoe cover in waste bin.
- Open the outside door of male visitor Change Room to exit.
- Exit & de gowning procedure for Female visitor Change Room
- Open the door of female visitorchange room from the plant side & enter.
- Remove the apron, cap & put it in the used dress cabinet.
- Sit & swing over the cross over bench.
- Remove the shoe cover in waste bin.
- Open the outside door of female visitor Change Room to exit.
NOTE: –
Any person suffering from any contagious/infectious disease shall not be allowed to enter in GMP area.
Pictorial display of entry/exit procedure shall be displayed in respective change room.
- REFERENCES:
Not Applicable
- ANNEXURES:
| ANNEXURE No. | TITLE OF ANNEXURE |
| Annexure-I | Dress inspection record |
ENCLOSURES: SOP Training Record.
- DISTRIBUTION:
| Controlled Copy No. 01 | : | Head Quality Assurance |
| Controlled Copy No. 02 | : | Head Production |
| Controlled Copy No. 03 | : | Head Warehouse |
| Controlled Copy No. 04 | : | Head Quality Control |
| Controlled Copy No. 05 | : | Head Engineering |
| Controlled Copy No. 06 | : | Head HR & Administration |
| Master Copy | : | Quality Assurance Department |
- ABBREVIATIONS:
| No. | : | Number |
| Dept. | : | Department |
| Ltd. | : | Limited |
| QA | : | Quality Assurance |
| SOP | : | Standard Operating Procedure |
- REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To be written manual |
Click the link for download word file copy of this document:
https://pharmaguidehub.com/product/entry-exit-gowning-de-gowning-procedure-for-staff-operators-workers-visitor-to-the-plant/
ANNEXURE-I
DRESS INSPECTION RECORD
Frequently Asked Question?
Q: Are there any restrictions on personal belongings in the production area?
A: Yes, ornaments, food, and cell phones (except for authorized personnel) are not allowed in the production area. Personal belongings must be kept in lockers.
Q: Where are the lockers located?
A: Locker shall be located in change room.
Q:Are there separate change rooms for men and women?
A: Yes, there are separate change rooms for men and women.
Q: Do visitors need to wear street shoes/slippers in the plant?
A: No, visitors must wear shoe covers provided in the change room.
Q: Where are used shoe covers disposed of?
A: Used shoe covers should be disposed of in a waste bin.
Click the link for download word file copy of this document:
https://pharmaguidehub.com/product/entry-exit-gowning-de-gowning-procedure-for-staff-operators-workers-visitor-to-the-plant/
