A robust QMS aligns with the core principles of GxP, including maintaining data integrity, traceability, and accountability, while enabling secure sharing of files and reports across various groups. A well-structured quality system offers the necessary tools to:
• Establish, communicate, and update standard operating procedures for each process or functional area
• Mitigate risks at all stages by identifying and managing corrective and preventive actions to minimize errors
• Exercise control over processes to meet required standards in end products and facilitate continuous improvement
• Adapt procedures in response to regulatory changes or emerging market opportunities
• Facilitate prompt provision of documentation during inspections or regulatory audits
• Record and archive data to validate task completion, ensuring the data is attributable, legible, contemporaneous, original, and accurate.

1. Purpose:
- GCP is an internationally recognized ethical and scientific quality standard for clinical trials.
- It aims to ensure the safety of human subjects participating in research studies.

2. Origin and Standardization:
- Developed by the International Council for Harmonisation (ICH).
- ICH sets global standards for clinical trials involving human subjects, which can be adopted by governments to form regulations.

3. U.S. GCP Specifications:
- GCP specifications in the United States include:
- FDA 21 CFR 50: Protection of human subjects.
- FDA 21 CFR 54: Financial disclosure.
- FDA 21 CFR 56: Institutional review boards.
- FDA 21 CFR 312: Trial administration for an investigational new drug application.
4. European Regulation and Guidance:
- The European Medicines Agency provides guidance through:
- Clinical Trial Directive (2001/20/EC).
- GCP Directive (2005/28/EC).

GMP, or Good Manufacturing Practice, entails a set of guidelines defining the necessary standards for the production of investigational drugs and biologics. These guidelines ensure proper identification, quality, purity, and potency of medical products to guarantee patient safety and effectiveness. In the United States, GMP regulations are outlined in FDA 21 CFR 210-211 for drugs and 21 CFR 600 for biologics. The European Union, through the EMA, has established similar directives.

To ensure GxP compliance and maintain high-quality standards at Zenovel, it's crucial to establish a robust Quality Management System (QMS) that aligns with regulatory requirements. Here are some best practices for achieving this:

Recruit Qualified Personnel: Start by hiring employees who are well-qualified and experienced in maintaining a QMS. Ensure they have a deep understanding of GxP regulations and compliance standards.

Develop Comprehensive SOPs: Create Standard Operating Procedures (SOPs) that provide detailed guidelines for controlling facilities, equipment, laboratory operations, and data recording. These SOPs should align with GxP regulations and be regularly updated to reflect industry best practices.

Continuous Training: Conduct regular training sessions for employees on GxP standards and SOPs. Ensure that all staff members are well-informed and up-to-date on compliance requirements.

Internal Audits: Periodically challenge the QMS with internal audits to identify and rectify any potential issues or non-compliance issues. These audits should be tailored to the specific GxP area:

• For GCP (Good Clinical Practice), perform site audits before initiating clinical trials to certify site readiness and prevent delays.
• For GMP (Good Manufacturing Practice), consider preapproval inspections (PAI) to demonstrate the capability of your production facility. Prior to scheduling a formal PAI, it's advisable to have an external party assess your QMS from a regulator's perspective and provide PAI readiness training for all employees.