Standard Operating Procedure for Entry to and Exit from Dispensing and Sampling area

Standard Operating Procedure for Entry to and Exit from Dispensing and Sampling area
Standard Operating Procedure for Entry to and Exit from Dispensing and Sampling area

Standard Operating Procedure for Entry to and Exit from Dispensing and Sampling area

1. Purpose:

To lay down a procedure for Entry to and Exit from Dispensing and Sampling area in the pharmaceutical warehouse.

2. Scope:

The scope of this is applicable for Entry to and Exit from Dispensing and Sampling area in the pharmaceutical warehouse at [company name].

3. Responsibility:

Authorized Person: Entry to and Exit from Dispensing and Sampling area

Head Warehouse: Effective implementation of SOP

4. Definitions:

Not Applicable

5. Procedure:

5.1 Entry procedure for employee:

• Enter in the warehouse as per entry and exit procedure applicable for warehouse as per respective SOP.

• Person who wants to enter into the dispensing or sampling area shall enter into the change room.

• Gown shall be used as follows.

a. General category product:

Gown color code and typesApplicable department
White over gown, headgear and booties/ shoe coverWarehouse, Manufacturing
Dark blue color over gown, headgear and booties/ shoe coverEngineering
Sky blue color over gown, headgear and booties/ shoe coverQuality Control Quality Assurance
Disposable cap, apron and trouser, shoe coverVisitors

b. Low PDE value (≤10 µg/day) product – Disposable over gown, headgear and booties

• Before wearing the gown, ensure that it is clean and free from loose thread.

• Person wants to enter in the dispensing and sampling area shall wear nose mask, headgear, over gown and shoe cover in the change room. Personal Protective Equipment shall be used as applicable.

• While wearing booties/ shoe cover, sit on the cross over bench put one leg in the middle of the cross over bench wear booty, bring down the leg other side of the cross over bench. Repeat this procedure for the second leg.

• Verify the adequacy of gowning in the mirror.

• Disinfect the hands using disinfectant solution [Specify qualified hand disinfectant name] provided at the entrance.

• Hand gloves shall be used while carryout the dispensing and sampling activity. Hand gloves shall be replaced as and when needed (e.g. if it is torn or contaminated, etc.)

• Pictorial representations are displayed in the change room for quick reference for the personnel entering in the dispensing or sampling area and exiting from the same areas.

• Hand gloves shall also be changed after each material handling (before handling another material).

• The personnel who want to enter in the sampling or dispensing area and do not have authorization, they can be escorted by authorized person.

5.2 Entry procedure for visitors:

• The authorized person who escort visitor shall follow visitor gowning procedure.

• Enter into the change room.

• Wear nose mask, disposable cap, apron and trouser.

• Sit on the cross over bench, place one leg in the middle of the cross over bench, wear shoe cover, and bring down the leg other side of the cross over bench. Repeat the procedure for the second leg.

• Check the adequacy of gowning in the mirror. Adjust if require

• Disinfect the hand using disinfectant solution [Specify the name of qualified disinfectant name].

• Enter in the sampling or dispensing area.

5.3 Exit procedure for employee:

• After completion of dispensing or sampling activity remove the hand gloves in the same area, cut the used hand gloves to make it unusable and discard it in waste bin. Return to the exit change room.

• Remove the shoe cover by sitting on the crossover bench, stepped over the legs to the cross over bench. Follow the same for second leg.

• Discard the shoe cover in the waste bin. Remove the nose mask, over gown and place them in the used gown bin.

• Move out from the change room.

• Pictorial diagram are displayed in the change room for ready reference.

5.4 Exit procedure for visitor:

• Enter in the exit change room.

• Remove the shoe cover by sitting on the crossover bench, stepped over the legs to the cross over bench. Follow the same for second leg.

• Discard the shoe cover in the waste bin. Remove the nose mask, over gown and place them in the used gown bin.

• Move out from the change room.

• Pictorial diagram are displayed in the change room for ready reference.

6. Frequency:

During every entry to and exit from the dispensing and sampling area.

7. Formats:

No format for recording.

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