Healthcare GMP Document

HEALTHCARE GMP COMPLIANCE CERTIFICATION

Facility Identification

Scope of Certification

Facility certifies that the following activities at the named facility are performed under established Good Manufacturing Practice systems and are included in this certification:

Regulatory and Licensure

I hereby declare that the facility maintains all required permits, registrations, and licenses necessary for the scope of operations and that information below is true and accurate.

Quality Management Systems and Controls

The facility confirms implementation and maintenance of the following GMP elements. Check the control categories that apply and provide references to governing documented procedures.

Production, Validation and Environmental Controls

Provide a concise statement of validated processes and environmental control programs. Include validation status where applicable and the schedule for requalification.

Personnel, Training, and Hygiene

The facility affirms that personnel performing GMP activities have received role-appropriate training and that records are maintained consistent with written procedures.

Supply Chain and Materials Control

Confirm procedures for supplier qualification, incoming materials testing, and traceability of raw materials and critical components.

Deviations, CAPA, and Internal Audits

Facility confirms existence of a documented program for deviation investigation, corrective and preventive action (CAPA), and periodic internal audit. Provide recent audit and CAPA metrics.

Records Retention and Traceability

The facility attests to maintaining complete manufacturing and quality records in retrievable format for the period required by applicable law and internal policy.

Representations and Attestations

By signing below, the authorized representative of the facility certifies under penalty of perjury that: (a) the statements and attachments provided herein are true, correct, and complete to the best of their knowledge; (b) the facility operates in material compliance with applicable Good Manufacturing Practice requirements for the activities listed in the Scope of Certification; and (c) the facility will promptly notify designated recipients in writing of any material changes that would affect the accuracy of this certification.

Certification Effective and Expiration Dates

This certification is effective as of the Effective Date below and will remain in effect until the Expiration Date unless earlier revoked in writing by the facility.

Right to Audit and Inspections

Facility acknowledges that, upon reasonable notice and subject to agreed confidentiality protections, it will permit audits and inspections by authorized representatives in order to verify compliance with GMP obligations and the statements made in this certification.

Attachments and Supporting Evidence

Attach or reference inspection reports, recent internal audit summaries, validation certificates, and key SOPs relied upon to support the representations in this certification.

Authorized Representative Certification

The undersigned, having authority to bind the facility, certifies that the statements contained in this Healthcare GMP Compliance Certification are accurate and that the facility will maintain the systems and records necessary to substantiate this certification for the duration of the retention period stated above.

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