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Standard Operating Procedure (SOP) for Entry and Exit in the primary area of production at the pharmaceutical drug manufacturing plant.

Procedure for Entry and Exit in the Primary Area

1.0   PURPOSE:

• • The purpose of this SOP is to laydown the entry and exit procedure in the Primary Area of the production department at the pharmaceutical plant.

2.0   SCOPE:

• • This procedure shall be applicable for the secondary change room/cubicle or cubicle airlock, required to access the manufacturing and primary packing facility.

• • This procedure shall be applicable for all employees, workmen, visitors, and auditors to enter the primary area.

3.0   REFERENCES:

• • In Houses.

• • SOP for Dress Code for entry in Production, Warehouse, QC Area.

4.0   RESPONSIBILITY- ENTRY AND EXIT PROCEDURE:

• • The production 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.

• • To provide the required secondary gown (Snood, Nose mask, Boiler suit, Booties, and hand gloves) to all employees, workmen, visitors, and auditors.

• • QA shall be responsible for review and to ensure that the laydown procedure is followed as per SOP.

• • 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:

• • GMP: Good Manufacturing Practices

• • HR: Human Resource

• • IPA: Isopropyl Alcohol

• • QA: Quality Assurance

• • SOP: Standard Operating Procedure

• • HOD: Head of Department.

7.0   PROCEDURE FOR ENTRY AND EXIT IN PRIMARY AREA:

• General Instruction of Entry and Exit Procedure-

• • All personnel shall inform proactively about the illness, open wounds to the department head prior to entering the primary area.

• • HOD of concern department shall guide the employee for further precaution or prevention if required, 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.

• • Eating and chewing shall be prohibited in the primary area.

• • Ensure the wearing ornaments, wristwatch, etc. kept in a cupboard or designated place with lock & key of the primary change room.

• • Do not wear secondary gown outside the primary area.

• • Do not touch any primary medicines with naked hands.

• • During the break, place the secondary gown in a crate/container or designated place.

• • Ensure that the hairs, nails are trimmed and clear from cosmetic applications.

• • Shave your beard on a regular basis (for Gents).

• • Wear proper secondary gowning (Snood, Nose mask, Boiler suit, Booties, and hand gloves).

• • Ensure the door in the close condition of the second change room/cubicle or cubicle airlock.

• • 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.

• • Materials shall be move-in closed condition via secondary change room/cubicle or cubicle airlock.

• Entry and Exit Procedure for Primary Area.

• • Entry Procedure:

• • All company employees, visitors, and auditors shall access the intended area through the respective secondary change room/cubicle or cubicle airlock.

• • Follow the sequence of entry and exit steps as per displayed photographic presentation.

• • Open the door and enter into the secondary change room/cubicle or cubicle airlock.

• • Ensure all the personal ornament shall be kept in the cupboard under lock & key of the primary change room. E.g. key ring, wristwatch, etc.

• • Collect the fresh gown (Snood, Nose mask, Boiler suit, Booties, and Hand gloves) from the cleaned cloth crate/container or designated place and followed the gowning sequence:

• • • Nose mask (Note: Wear 3M nose mask as per requirement otherwise wear disposable ordinary mask only).

• • • Boiler suit.

• • • Hand gloves.

• • All employees, visitors & auditors shall wear Snood, Nose mask, Boiler suit, Booties & hand gloves and enter into the primary area (As per the displayed photographic sequence).

Related: SOP for Training Management

• • Collect and wear the fresh gown (Snood, Nose mask, Boiler suit, Booties, and Hand gloves) in the designated places.

• • Look into the mirror for proper gowning and ensure the covering of hair, etc. prior to exit from the secondary change room to the primary packaging area.

• • Sanitize the hands by using the sanitizing solution provided in the secondary change room.

• • Ensure proper spreading and drying of the disinfectant by rubbing the fingers, finger joints and palms.

• • Open the door and move into the primary area via a secondary change room or cubicle airlock.

• • Exit Procedure:

• • All personnel moving out from the respective working area shall enter into the secondary change room or cubicle airlock.

• • Open the door and enter into the secondary change room or cubicle airlock.

• • Remove the gowning (Snood, Nose mask, Boiler suit, Booties & hand gloves) keep in the designated place.

• • During the break, Keep the used gown in the crate/container or designated place and can use for the rest of the day or after the break.

• • Used gown shall be dropped into the used gown crate/container or designated place 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.

• • Open the door and move out from the change room/cubicle or cubicle airlock.

8.0   DISTRIBUTION:

• • Quality Assurance

• • Engineering

• • Personnel and Administration

• • Environment, Health & Safety (EHS)

9.0   ANNEXURES- SOP FOR ENTRY AND EXIT PROCEDURE:

Annexure 1: Flow chart of Entry and Exit Procedure.

• ENTRY PROCEDURE-

• • First Step: Enter into the Secondary Change Room/ Cubicle or Cubicle airlock.

• • Second Step: Collect the fresh gown (Snood, Nose mask, Boiler suit, Booties, and Hand gloves).

• • Third Step: Wear the fresh gown (Snood, Nose mask, Boiler suit, Booties, and Hand gloves).

• • Fourth Step: Look into the mirror for proper gowning (as per availability).

• • Fifth Step: Sanitize the hands by using the sanitizing solution (as per availability).

• • Sixth Step: Move into the primary area

• EXIT PROCEDURE-

• • First Step: Enter into the Secondary Change Room/ Cubicle or Cubicle airlock.

• • Second Step: Remove the secondary gowning and keep it in designated place.

• • Step 2.1: During breaks, Keep the used gown in the crate/container or designated place and can use for the day or after the break.

• • OR

• • Step 2.2: Drop the used gown into the used gown crate/ container or designated during shift change.

• • Fourth Step: Move out from the secondary change room/cubicle or cubicle airlock.

Annexure 2: Code of Conduct of Entry and Exit Procedure-

• • All personnel shall inform proactively about the illness, open wounds to the department head prior to entering the primary area.

• • HOD of concern department shall guide the employee for further precaution or prevention if required, 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.

• • Eating and chewing shall be prohibited in the primary area.

• • Ensure the wearing ornaments, wristwatch, etc. kept in a cupboard or designated place with lock & key of the primary change room.

• • Do not wear secondary gown outside the primary area.

• • Do not touch any primary medicines with naked hands.

• • During the break, place the secondary gown in a crate/container or designated place.

• • Ensure that the hairs, nails are trimmed and clear from cosmetic applications.

• • Shave your beard on a regular basis (for Gents).

• • Wear proper secondary gowning (Snood, Nose mask, Boiler suit, Booties, and hand gloves).

• • Ensure the door in the close condition of the second change room/cubicle or cubicle airlock.

• • Any prescribed medicines required during duty shall keep in security or HR. No medicines allowed inside the change room lockers or any other places.

• • Materials shall move-in closed condition via secondary change room/cubicle or cubicle airlock.