Visitor GMP Policy Reception Staff Responsibilities SOP 12

Visitor GMP Policy Reception Staff Responsibilities SOP 12. 345 Presented By: Rachel Barton Quality Assurance Analyst II

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.

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 c. GMP (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.

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.

Policy and Guide to Government Audits Reception Staff Responsibilities and info. SOP 20. 602 Presented By: Rachel Barton Quality Assurance Analyst II

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. v Typical Government Bodies: v. FDA (Food and Drug Administration) v. TGA (Therapeutic Goods Administration) Australia

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. v. Officials of the United States are required to present photo I. D. credentials. Foreign investigators usually have similar credentials

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.

Please Contact Internal QA Department for More Information and Training