ICH Guidelines – Safety, Quality, Efficacy

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PRINCIPLES OF QUALITY RISK MANAGEMENT © ICH

According to the ICH, two primary principles of quality risk management are:

• The evaluation of the risk to quality should be based on scientific knowledge and
ultimately link to the protection of the patient. (Note: Risk to quality includes situations
where product availability may be impacted, leading to potential patient harm.)
• The level of effort, formality and documentation of the quality risk management process
should be commensurate with the level of risk. ICH Q9(R1) Guideline 3

GENERAL QUALITY RISK MANAGEMENT © ICH

Quality risk management is essentially a position created in order to assess, control, and review all aspects of any potential risks to the quality of the pharmaceutical or drug product. In most cases, the product is a medicine created and ultimately administered by accredited pharmaceutical and potentially medical device companies. There is an emphasis on each part of a facility that has anything to do with either of those two industries. Quality risk management ensures the safety of the developers of the product, the facilities where the products are stored, and ultimately the end-user (the patient.) In quality risk management, not only is quality focused on but so is efficacy and safety. Every facility in the world should focus on and attain to the standards of the ICH as well as ISO. 

Here at Purple Diamond we take Quality Management very seriously. Our Quality Assurance Manager’s Duties include, but are not limited to:

1. Ensuring compliance with International Organization (ISO)/ International Electrotechnical Commission (IEC) 17025:2017 – Testing and Calibration Accreditation Standards

2. Updating and maintaining an appropriate system of Standard Operating Procedures (SOP’s), Internal Control, Standards, and Procedures Relating to Production and Facility Operations

3. Maintaining and monitoring project plans and project schedules.

4. Ensuring projects adhere to frameworks and all documentation is maintained appropriately for each project.

5. Monitoring and evaluating testing results and providing feedback to the employees and the executive team.

6. Provide technical direction on product announcements, marketing brochures, advertisements and marketing specifications.

7. Provide support to various initiative such as testing, specifications and technical documents.

8. Evaluate test materials and write final test reports as needed.

9. Contribute to testing and engineering schedules and plans. 

10. Conduct and report ISTA, ASTM and UN / HazMat Testing.

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