OBJECTIVE:

• To establish a uniform procedure for the control, entry, identification, supervision, and safety of contractors, service personnel, and visitors entering company premises to ensure product, personnel, and environmental safety as per WHO GMP requirements.

SCOPE:

• This SOP applies to all external personnel — including contractors, suppliers, auditors, consultants, and visitors — who enter manufacturing, laboratory, warehouse, or utility areas of the facility.

RESPONSIBILITIES:

Human Resource (HR) Department:

• Coordinate approval and record-keeping for all visitor and contractor entries.
• Maintain Visitor and Contractor Registers.
• Ensure safety, health, and confidentiality declarations are signed before entry.

Security Department:

• Verify visitor or contractor identity and entry authorization.
• Issue temporary ID cards or visitor passes and maintain gate entry logs.
• Ensure compliance with safety and gowning requirements before entry.

Department Head:

• Supervise the visitor or contractor during their stay inside premises.
• Ensure access is limited only to authorized and relevant areas.

Visitor / Contractor:

• Follow all site safety, hygiene, and GMP rules strictly.
• Wear PPE provided and sign confidentiality and health declaration forms before entry.

DEFINATIONS:

• Visitor: Any person not employed by the company who enters the premises for business, audit, or official purposes.
•  Contractor: External personnel engaged temporarily for installation, maintenance, repair, or service work.
•  Escort: Authorized company employee responsible for supervising a visitor/contractor during the visit.

 PROCEDURE:

Prior Intimation and Approval:

• All visitor or contractor visits shall be pre-approved by the concerned Department Head.
• Security shall issue Visitor/Contractor pass with details such as name, purpose, duration, and area of visit.
• QA approval is mandatory for GMP area access.

Entry Procedure:

• At the security gate:
  • • Visitor identity (ID card, passport, or company ID) shall be verified.
    • Mobile phones, cameras, and external storage devices are prohibited unless permitted in writing.
    • Visitor/Contractor must sign the Visitor/Contractor Register.
    • Security shall issue a Temporary ID Card / Visitor Pass and PPE, if required.
    • HR or designated escort shall accompany the visitor throughout the visit.

Safety and Gowning:

• Before entry, HR/SHE Officer shall explain basic site safety, emergency exits, and restricted zones.
• Contractors performing work shall be trained in PPE usage and emergency procedures.
•  For clean areas, visitors must comply with gowning as per respective area classification.

 Conduct:

• Eating, drinking, smoking, photography, and handling materials are strictly prohibited inside GMP areas.
•  Visitors must remain with their escort at all times.

 Exit Procedure:

• On completion of the visit/work:
• • • Visitor/Contractor shall return ID card, PPE, and any borrowed tools/equipment.
    • Escort shall confirm completion of visit in Visitor Exit Record (Annexure-III).
    • Security shall record time-out in the gate register.
• HR shall review and file the completed forms for documentation.

 REFERENCES:

• WHO TRS 986, Annex 2 — Good Manufacturing Practices: Personnel and Training
•  ISO 9001:2015 — Clause 7.2 Competence

 RECORDS:

 REVISION HISTORY.