When it comes to pharmaceutical product development, adhering to the highest standards of quality and safety is paramount. The ICH guidelines, including ICH Q9(R1), emphasize the critical role of quality risk management in safeguarding patients by ensuring that pharmaceutical products are safe, effective, and readily available.
At Purple Diamond, we take these ICH guidelines seriously, particularly when it comes to ICH Stability Storage and Studies for your pharmaceutical products. Our quality management approach involves a thorough evaluation of risks based on scientific knowledge, ensuring that every step, from product testing to storage, meets international standards like ISO and IEC 17025:2017.
Explore some of the key ICH guidelines below.
Principles of Quality Risk Management
ICH guidelines for quality risk management is essentially a position created in order to assess, control, and review all aspects of any potential risks to the quality, safety, or efficacy 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. 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.)
According to the ICH Guidelines, two primary principles of quality risk management are:
- The ICH Guidelines 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, ICH Guidelines
In essence, the ICH guidelines provide a robust framework for ensuring that quality risk management in pharmaceuticals is scientifically grounded, patient-focused, and proportionate to the level of risk, ultimately safeguarding both product integrity and patient health throughout the product lifecycle.
A full list of ICH guidelines is available here.
Quality Risk Management at Purple Diamond
Here at Purple Diamond we take Quality Management very seriously. Our Quality Assurance Manager’s Duties include, but are not limited to:
- Ensuring compliance with International Organization (ISO)/ International Electrotechnical Commission (IEC) 17025:2017 – Testing and Calibration Accreditation Standards
- Updating and maintaining an appropriate system of Standard Operating Procedures (SOP’s), Internal Control, Standards, and Procedures Relating to Production and Facility Operations
- Maintaining and monitoring project plans and project schedules.
- Ensuring projects adhere to frameworks and all documentation is maintained appropriately for each project.
- Monitoring and evaluating testing results and providing feedback to the employees and the executive team.
- Provide technical direction on product announcements, marketing brochures, advertisements and marketing specifications.
- Provide support to various initiative such as testing, specifications and technical documents.
- Evaluate test materials and write final test reports as needed.
- Contribute to testing and engineering schedules and plans.
- Conduct and report ISTA, ASTM and UN / HazMat Testing.
ICH guidelines serve as a cornerstone for ensuring quality risk management in pharmaceutical product development, safeguarding both product integrity and patient safety. At Purple Diamond, we are committed to upholding these standards through rigorous testing, stability storage, and adherence to internationally recognized regulations. By choosing Purple Diamond, you’re ensuring that your products are handled with the utmost care and professionalism every step of the way.
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