Entry and Exit Procedure in QC Laboratory

Standard Operating Procedure (SOP) for Entry and Exit Procedure in Quality Control (QC) Laboratory in a pharmaceutical plant.

Entry and Exit Procedure in QC Lab

1.0   PURPOSE:

    • The purpose of this SOP is to laydown the entry and exit procedure for Quality Control (QC) Laboratory area.

2.0   SCOPE:

    • This procedure shall be applicable to the change room required to access the Quality Control facility.
    • This procedure shall be applicable for all Employees, Workmen, Visitors, and Auditors enter to the quality control area.

3.0   REFERENCES:

    • In Houses.
    • SOP for Dress Code for entry and exit in Production, Warehouse, and QC Area.

4.0   RESPONSIBILITY – SOP for Entry and Exit in QC:

    • Quality Control department shall be responsible for checking the laydown procedure is followed.
    • To ensure the availability of resource requests for the adherence of entry and exit procedure as per SOP for Entry and Exit in QC Lab.
    • To provide required uniform and safety shoes to all employees, workmen. (Note: shoe cover shall provide for visitors and auditors)
    • QA shall be responsible for review and to ensure that the laydown procedure is followed as per SOP for Entry and Exit procedure in QC Laboratory.
    • Plant Head and Quality Head shall be responsible for the review and approval of the SOP and to ensure the compliance of this laydown procedure.

5.0   ABBREVIATIONS USED IN SOP FOR ENTRY AND EXIT PROCEDURE IN QC:

    • GMP: Good Manufacturing PracticesEntry and Exit in QC
    • HR: Human Resource
    • IPA: Isopropyl Alcohol
    • QA: Quality Assurance
    • QC: Quality Control
    • SOP: Standard Operating Procedure

7.0   PROCEDURE FOR ENTRY AND EXIT IN QC LABORATORY:

  • General Instructions of Entry and Exit in QC :

    • All personnel shall inform proactively about the illness, open wounds to the department head prior to entry to the quality control area.
    • HOD shall guide the employee for further precaution or prevention if required to be taken, in case of any illness, open wounds.
    • Personnel or concern HOD shall inform to HR. In such case do not resume on duty. Before resuming duty submit the medical certificate to HR.
    • Before entering the change room, keep all eatables, chewable, or beverages in the canteen only.

Related: SOP for Entry and Exit Procedure in the Primary Area

    • Eating and chewing shall be prohibited in the quality control area.
    • Ensure the wearing ornaments, wristwatch, bindi, etc. kept in cupboard/place with lock & key.
    • Do not wear factory uniforms outside the quality control area.
    • During the break, place the factory uniform in designated cupboard/place.
    • Ensure that the hairs, nails are trimmed and clear from cosmetic applications.
    • Shave your beard on a regular basis (for Gents).
    • Wear safety shoes and shoes must completely cover the foot.
    • Ensure the door in the close condition of the change room.
    • Any prescribed medicines required during duty shall be kept in security or HR.
    • No medicines allowed inside the change room lockers or any other places.
  • Entry & Exit Procedure for QC Change Room:
    • Entry Procedure:

    • All company employees, visitors, and auditors shall access the intended area through the respective change rooms.
    • Open the door and enter into the change room.
    • Follow the sequence of entry and exit steps as per the displayed photographic sequence.
    • Remove the street footwear and keep it in the designated cupboard/designated place under lock and key.
    • Keep the entire personal ornaments e.g. a key ring, wristwatch, bindi, etc. in the designated place under lock and key.
    • Collect the shoes or shoes cover from the designated place.
    • Collect the fresh gown from the cleaned cabinet.
    • All employees shall wear apron & safety shoes and enter into the quality control area (As per the displayed photographic sequence).

Note: Visitors & Auditors shall wear apron & shoes cover and enter into the quality control area (As per the displayed photographic sequence).

    • Open the allocated cupboard for safety shoes and also wear the fresh gown from the designated place.
    • Look into the mirror for proper gowning and ensure the covering of hair, etc. prior to exit from the change room to the quality control area.
    • Sanitize the hands by using the sanitizing solution provided in the change room.
    • Ensure proper spreading and drying of the disinfectant by rubbing of the fingers, finger joints and palms.
    • Open the door and move into the quality control area.
    • Exit Procedure:

    • All personnel moving out from the respective department shall enter into the change room.
    • Open the door and enter into the change room.
    • Remove the gowning and safety shoes or shoes cover and keep in the designated place.
    • During the break, the used gown shall be kept in the cupboard/designate place and can be used for the rest of the day or after the break.
    • Used gown shall be dropped into the used gown cabinet after the end of shift and housekeeping personnel shall collect them in a plastic bag and send for washing with the label “TO BE CLEANED”.
    • Ensure all personnel gowning shall be kept in the designated place.
    • Collect and wear street footwear from the designated place.
    • Open the door and move out of the change room.

9.0   ANNEXURES – SOP FOR ENTRY AND EXIT IN QC LAB:

Annexure 1: Flow chart of Entry and Exit Procedure in QC.

ENTRY PROCEDURE –

Step 1

Enter into the Change Room.

Step 2

Remove the street footwear and keep it in the designated cupboard/place.

Step 3

Collect & wear a fresh gown and factory shoes in a designated place.

Step 4

Look into the mirror for proper gowning.

Step 5

Sanitize the hands using the sanitizing solution

Step 6

Move into the quality control

EXIT PROCEDURE –

Step 1

Enter into the Change Room from QC.

Step 2

Remove company uniform & factory footwear to keep it in the designated place.

Sub Step 2.1

During breaks, the used gown shall be kept in the cupboard/place and can be used for the day or after the breaks.

OR

Sub Step 2.2

Used gown shall be dropped into the used gown cabinet during shift change.

Step 3

Collect and wear street footwear in designated places.

Step 4

Move out from the change room

Annexure 2: Code of Conduct.

    • All personnel shall inform proactively about their illness, open wounds to the department head and HR or Security, prior to entering to the quality control area.
    • In such case do not resume on duty.
    • Submit the Fitness certificate before resuming the duty.
    • Before entering the change room, keep all eatables, chewable, or beverages in the canteen.
    • Ornaments, wristwatch, bindi, nail polish or false fingernails, etc. avoid worn in the manufacturing area
    • Keep all such types of personal belongings in the designated places.
    • Ensure that the hairs, nails are trimmed on a regular basis & clear from cosmetic applications.
    • Shave your beard on a regular basis (For Gents).
    • Permit access to the quality control area through the change room only after wearing proper owning.
    • Look into the mirror for proper gowning prior to entry into the manufacturing area.
    • Wear factory shoes and shoes must completely cover the foot.
    • Do not allow the street footwear in quality control
    • Do not wear a lab coat/apron outside the quality control area.
    • During the break, keep the factory uniform at the designated place.
    • When crossing the door, ensure the doors are in closed condition.
    • Keep the prescribed medicines required during duty in security or HR.
    • No medicines allowed inside the change room lockers or any other places.
    • Do not carry a mobile and any other electronic devices in the manufacturing area. Allow to authorized personnel only.

pharmabeginers

Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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