1. Visitor GMP Policy Reception Staff Responsibilities SOP 12.345
Presented By:
Rachel Barton
Quality Assurance Analyst II

2. Receptions Responsibility
Is responsible for ensuring visitors review the Visitor GMP Policy and sign the visitor log.
Policy and log located on reception desk
Requirements are translated for non-English speaking visitors.
Authorized Vendors do not need to sign the log. Access is restricted to dock areas.
Guard or guide dogs are not allowed in production or laboratory areas where contamination may occur.

3. Escorts Role
Escort(s) must ensure requirements are adhered to. The visitor is the responsibility of the escort.
Escorts for tours must be knowledgeable of cGMP (Current Good Manufacturing Processes) and hygiene policies.
Individual(s) with obvious illness or communicable diseases are not permitted to enter any production areas; expectation is that visitors are in good health.
Chewing gum, chewing tobacco, or eating food is prohibited in production, laboratory, and warehouse areas.
Employees cannot smoke within the facility or on company grounds. Vendors and visitors must smoke outside at least 25 feet from any building, in accordance with the Utah Indoor Clean Air Act.
Photography and recordings are not allowed without permission from upper management.

4. Visitors
Visitors must read and understand the requirements of the Visitor GMP Policy.
Translation is provided as needed.
Visitors must sign that they acknowledge and understand the requirements.
By signing the visitor log, visitors agree to abide by the listed requirements.
Visitor(s) must follow internal Personal Health and Hygiene Level designation gowning procedures before entering any production, laboratory, or warehouse area.
Escort is to ensure GMP is followed.

5. Policy and Guide to Government Audits
Reception Staff Responsibilities and info.
SOP
Presented By:
Rachel Barton
Quality Assurance Analyst II

6. Receptionist
Responsible for notifying the primary contact and/or others as described in this procedure.
Receptionist is the first contact with an investigator
Be courteous.
Do not keep the inspector waiting.
Typical Government Bodies:
FDA (Food and Drug Administration)
TGA (Therapeutic Goods Administration) Australia

7. Contact the following:
Primary Contact: Quality Assurance Manager
The Quality Assurance contact person must notify executive members.
Executive Director of Quality and Regulatory Affairs
Executive Director of Global Operations
Director of Quality Control
Other staff as available.
Officials of the United States are required to present photo I.D. credentials. Foreign investigators usually have similar credentials

8. Government Investigation Proceeds as Follows
Notify the primary contact.
The Quality Assurance contact person must notify executive members.
The inspection cannot proceed until the investigator provides the proper credentials; the inspector is presented with President’s Letter to External Auditors, VIP designated visitor badge, and signs the Visitor GMP Sign-In Form.
The FDA inspector presents a signed FDA 482 form “Notice of Inspection” to the contact person. Other agencies have similar policies.

9. Please Contact Internal QA Department for More Information and Training