OBJECTIVE:

• To define the controlled procedure for entry and exit of personnel into/from the manufacturing block.

 SCOPE:

• Applicable to all personnel entering or exiting the manufacturing block.

RESPONSIBILITIES:

All Personnel:

• Follow the procedure strictly

Production/Area Supervisor:

• Ensure compliance during entry and exit.

Human Resources (HR):

• Monitoring, and compliance verification

DEFINATIONS:

NA

 PROCEDURE:

Entry Procedure into Manufacturing Block:

Pre-entry Requirements:

• Only authorized personnel shall enter.
• Personnel shall be trained in basic GMP & hygiene.
• No personal belongings (mobile, jewelry, wallet, etc.) shall be taken inside.

Change Room – First Side (Outer Change Area)

• Remove Shoes, personal clothing accessories (watch, rings, etc.)
• Store items in designated lockers.
• Wear dedicated factory slippers / footwear (if applicable)

Crossing the Cross-over Bench:

• Sit on the cross-over bench and swing legs across to the clean side.
• No contact between dirty and clean side footwear.
• Bench shall act as physical segregation barrier.

 Change Room – Clean Side (Inner Change Area):

• Wear clean PPE in following sequence head cap (covering all hair), face mask (if applicable), Apron / gown and dedicated manufacturing footwear.
• Ensure PPE is clean, intact and proper fit (no loose clothing)

 Final Check Before Entry:

• Check in mirror that hair fully covered, no exposed skin (as applicable) and PPE properly worn.
• Follow visual display instructions (posted in change room)

Entry into Manufacturing Area:

• Enter only through designated entry door.
• Avoid touching walls, doors unnecessarily.
• Maintain discipline and restricted movement.

Movement Inside Manufacturing Area:

• Personnel shall stay within assigned area
• Any movement between different zones shall follow defined re-gowning procedure.

Exit Procedure from Manufacturing Block:

Change Room – Clean Side:

• Remove PPE in sequence like Apron / gown, Cap, Mask (if used) and Footwear.
• Dispose or place in designated bins for used PPE dirty bin.
• Crossing the Cross-over Bench sit on the bench.
• Move legs to outer side and ensure clean side footwear does not touch outer side.

Outer Change Area:

• Wear personal footwear and collect personal belongings from locker.
• Exit through designated exit door only.

REFERENCES:

• WHO TRS (Annex 2 – GMP for Pharmaceutical Products)
• EU GMP – Chapter 3 & 5 (Personnel & Premises)

RECORDS:

REVISION HISTORY.