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

1. Purpose:

To lay down a procedure for Entry and Exit to Dispensing or Sampling area.

2. Scope

The scope this document is to provide the procedure for Entry and Exit to Dispensing or Sampling area in pharmaceutical warehouse.

3. Responsibility

Authorized person of warehouse, production, and quality control laboratory: To follow entry and exit procedure to enter in sampling or dispensing area and exit from it.

Head of Department/ Designee warehouse: Overall responsible for compliance as per SOP for dispensing area.

Head of Department/ Designee quality control laboratory: Overall responsible for compliance as per SOP for sampling area.

4. Definitions

Not applicable

5. Procedure

5.1 Dress code for general product:

• Warehouse, Manufacturing Staff & Technicians: White over gown, headgear and booties.

• Engineering staff and technicians: Navy blue color over gown, headgear and booties.

• Quality Unit Staff: Blue colour over gown, headgear and booties.

• Visitors: Light green color cap, apron and trouser.

• Housekeeping: Gray over gown, headgear and booties.

5.2 Dress code for potent drug (having PDE value ≤10 mcg/day):

• Product dedicated gowns with disposable over gown.

• During each exit from dispensing or sampling area fresh secondary gown and new disposable over gown must be used.

• After use dedicated secondary gown shall be kept in separate dedicated container.

• One time use consumables, such as used disposable over gown, hand gloves, nose mask and shoe cover shall be collect separately and treat as a hazardous waste.

• List of potent drug product shall be maintained as ready reference to the users.

5.3 Sampling or dispensing area entry procedure for company employee:

Entry into the warehouse shall be done as per respective procedure to enter into the warehouse area.

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

• Over gowning shall be done inside the change room.

• Person shall take the gown from respective cabinet as per the color code and will verify the gown to ensure that it is clean and free from loose thread or particles.

• Person shall wear headgear with nose mask and do the over gowning in the change room.

• Person shall wear shoe cover (disposable or reusable as applicable) in the over change room. Process of wearing shoe cover is as follows.

• Lift the first leg and wear the shoe cover and tie the knots of shoe covers by placing the leg on the cross over bench. Once the first shoe cover wearing step is complete, place the first leg on other side of the cross over bench and wear the second shoe cover with similar process. Bring down the second leg to the other side of the cross over bench. Ensure that while wearing the show cover, uncovered led should not touch on the floor of cleaner side.

• Verify the appropriateness of gowning in front of the mirror.

• Disinfect their hands using disinfectant solution (Example 70% Isopropyl Alcohol) provided at the entrance to the dispensing or sampling room.

• Hand gloves shall be changed if it became dirty while working or there is puncture in it. It should be disinfected with disinfectant solution provided in dispensing or sampling area as and when required.

• For easy understanding of gowning process, pictorial representations are provided with sequential steps.

• Once person enters inside the dispensing or sampling area, wear hand gloves at entrance. Ensure that while wearing the hand gloves, skin hair should not stuck on the outer side of the hand gloves or fall on the floor, which could potentially contaminate the material. To avoid such situation, hand gloves should be wearing at the designated place.

• Used hand gloves shall be removed and new hand gloves should be used after every material handling, or as and whenever required (if it became dirty or it got punctured). If needed, intermittently hand gloves should be disinfected using disinfectant solution provided in dispensing or sampling area.

• Visitor or persons who are not authorized for warehouse routine activities can enter inside the area when trained and authorized employee accompany to them

5.4 Entry procedure for visitors:

• Visitors shall always enter in the area with authorized person only. The person who accompany visitor shall follow visitor gowning procedure (in case the purpose if only visit the area and not required to perform any activity).

• Visitor shall enter into the change room.

• Visitor shall wear nose mask, cap, overgrown as per defined color code for visitor.

• Visitor shall wear shoe cover (disposable or reusable as applicable) in the over change room. Process of wearing shoe cover is as follows.

• Check the proper gowning in front of the mirror.

• Disinfect the hand with disinfectant solution (70 % Iso Propyl Alcohol).

• Enter in to the sampling or dispensing area.

5.5 Exit procedure for employee:

• After completion of dispensing or sampling activity or exit from dispensing or sampling area remove hand gloves. Removal of hand gloves shall be done in such a way that if any possibility of kin hair removal, it should fall in the waste bin available in the area.

• Cut the used hand gloves using scissor before discarding it in the waste bin.

• Enter in to the change room.

• Remove outer shoe cover by while crossing over bench.

• Remove nose mask, over gown and place in the used over gown bin.

• Come out from the change room to warehouse.

• Pictorial representation will be displayed as per the sequence mentioned above.

5.6 Exit procedure for visitor:

• Enter in to the change room.

• Cross over the bench, remove the shoe cover and nose mask, and discard it into the waste bin.

• Remove the cap, over gown and place it into used over gown bin.

• Exit from the dispensing or sampling change room.

6. Frequency

During every entry and exit

7. Formats

Not applicable

Regulatory references of gowning procedures:

UNITED STATES: FDA: CFR – Code of Federal Regulations Title 21

Sec.211.28 Personnel responsibilities: (a) Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

EUROPEAN UNION: Eudralex, Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. Part 1- Chapter 2 Personnel

Section 2.18 Every person entering the manufacturing areas should wear protective garments appropriate to the operations to be carried out. Section 2.20 Direct contact should be avoided between the operator’s hands and the exposed product as well as with any part of the equipment that comes into contact with the products.

INDIA: CDSCO Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products. (Schedule M) Part 1 Good Manufacturing Practices for Premises and Materials

Section 7.6 Direct contact shall be avoided between the unprotected hands of personnel and raw materials, intermediate or finished, unpacked products. Section 7.7 All personnel shall wear clean body coverings appropriate to their duties. Before entry into the manufacturing area, there shall be change rooms separate for each sex with adequate facilities for personal cleanliness such as wash basin with running water, clean towels, hand dryers, soaps, disinfectants, etc. The change room shall be provided with cabinets for the storage of personal belongings of the personnel.