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Beyond Quality

Quality

Quality Management System

Establish and maintain a QMS that aligns with standards like ICH Q7 to ensure consistent product quality.

Risk Management

Perform thorough risk assessments for potential issues like impurity formation and process deviations to build quality in from the start.

Documentation to Quality

Maintain detailed records, including batch records and Standard Operating Procedures (SOPs), to ensure traceability and support investigations.

Compliance

Regulatory Adherence

Ensure all manufacturing activities and documentation comply with relevant national and international regulations from bodies like the FDA and EMA etc.

Good Manufacturing Practices

Implement and maintain GMP guidelines, which cover facility design, personnel training, process control, and quality assurance.

Compliance

Regulatory Adherence

Ensure all manufacturing activities and documentation comply with relevant national and international regulations from bodies like the FDA and EMA etc.

Good Manufacturing Practices

Implement and maintain GMP guidelines, which cover facility design, personnel training, process control, and quality assurance.

Safety

Facility and Equipment

Ensure the facility design and maintenance are clean, hygienic, and suitable for API production, with proper equipment management.

Material Control

Control the quality and handling of all raw materials to prevent contamination and ensure they are suitable for use.

Personnel Safety

Train staff on handling hazardous materials and emergency procedures to safeguard them from risks.

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