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Annex I checklist

I. General Requirements

Ensure compliance with applicable regulations and standards.

Define the scope of the manufacturing process.

Document the quality management system in place.

Conduct a risk assessment for the manufacturing processes.

II. Design and Development

Establish design and development planning procedures.

Maintain records of design inputs and outputs.

Verify and validate designs against defined requirements.

Implement design reviews at appropriate stages.

III. Production and Process Control

Develop and document manufacturing procedures.

Ensure adequate training for personnel involved in manufacturing.

Implement process validation and verification protocols.

Monitor and control production processes to ensure consistency.

IV. Quality Assurance

Establish a quality management framework.

Define inspection and testing procedures for raw materials and finished products.

Implement corrective and preventive action (CAPA) processes.

Conduct regular internal audits of the quality system.

V. Documentation and Record Keeping

Maintain comprehensive records of all processes and procedures.

Ensure traceability of materials and products throughout production.

Document non-conformities and actions taken.

Review and update documentation regularly to reflect current practices.

VI. Compliance and Regulatory Requirements

Identify relevant regulatory requirements applicable to the manufacturing sector.

Ensure all products meet necessary compliance standards.

Prepare for and participate in external audits.

Maintain an open line of communication with regulatory bodies.

VII. Continuous Improvement

Establish a framework for continuous improvement initiatives.

Encourage feedback from employees and stakeholders.

Set measurable goals for performance improvement.

Review and analyze performance data regularly to identify areas for enhancement.

This checklist can serve as a guide for manufacturing organizations to ensure their compliance with Annex I and to maintain high standards in their operations.

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