What is risk?
“The combination of the probability of occurrence of harm and the severity of that harm.” Guidance for Industry, FDA.
What is Quality Risk Management (QRM)?
Definition: In Pharmaceutical industry, “QRM is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product”, Guidance for Industry, FDA.
QRM, should not be implemented only in one particular area, but in the whole facility. Product development, Manufacturing, Laboratory control, Stability Testing, Facility and equipment changes, Storage & Distribution conditions, Qualification and Validation are some of the areas of operation where QRM should be implemented. At the same time, it is suggested that QRM, should not be used to justify non-compliance with GMPs, or any other mandatory requirement from a regulatory agency, but to reduce the risks to patients and improve the whole Pharmaceutical Quality System. There are a variety of tools, approaches recommended such as, PIC/S guide to GMP Annex 20 includes a list of tools commonly used.
However, examples of a particular process of the pharmaceutical industry are scarcely explained.
Identifying risks in Stability Testing
QRM is recommended to be implemented systematically through a process to define the risk, based on scientific knowledge and experience in that particular area. A systematic approach to risk management is described in chapter Q9 of the ICH guidelines starting from risk identification to risk evaluation, risk implementation and risk communication which is now also commonly used in all major GMPs. For example, if a manufacturer is establishing a stability testing program that should include product batch selection, testing frequency, storage condition, etc. Fortunately, all these parameters are defined in chapter Q1A of ICH guidelines.
However, it is not specified anywhere what kind of storage equipment, with reference to QRM, should be made available for meeting the very sample storage condition and its deviation limits. Seeking recommendations from an expert from the manufacturer of such equipment with scientific knowledge and experience would be the best way for implementing the QRM in the process of Stability Testing. A storage equipment called “Stability Chamber” should be provided by a specialized manufacturer, (e.g. NAGANO SCIENCE) that has long experience of providing stability testing chambers and the respective knowledge of regulatory requirements.
How NS supports in Risk Management?
Possible risks should be assessed in collaboration with the equipment manufacturer while you are storing your important product samples. Management and responsible for product quality and is ultimately seeking to keep product quality and safety to patients. Risk management is not a one time incident. Risk management is about permanently reviewing incidents and continually improving quality assurance efforts. In case of stability testing chambers, this means to make sure the entire storage room provides homogeneous conditions within requested limits, a correct measurement (display and true temperature identical) and that there is no interruption of operation.
Risks are assessed for a possible occurrence of failures. In risk assessments, questions such as, what if the chamber breaks down suddenly arise and assessing the measures provided such as back-up units, preventive maintenance plans, service contracts or other measures in place to assure uninterrupted operation take place. The Data integrity of the generated data is a must to be included in any risk assessment partial or even complete loss of data is a severe risk for a pharmaceutical company and is well in the spotlight of today’s audits and inspections by authorities. Process validation and equipment Qualifications are regulatory requirements and its provision is subject to any risk assessment.
Often storage stability testing is not the top priority of risk management and the consequences of failures are not as seriously considered as in other areas of tasks. A stability chamber which shows frequent and/or long periods of out of specification conditions puts the generated analytical data to the point of uncertainty to be correct. Is the trend observed caused by deterioration of the product or caused by the non-compliance of the storage condition. Once at this point product quality is at risk and costly measures need to be carried out to assure there is no impact to product quality.
Nagano Science with its expertise in providing solutions related to stability storage process works on preventive management rather than corrective management. For this reason, it implements the same Quality Risk Management first in its own Quality Management System as pharmaceutical companies, for instance, recommendation of Preventive Maintenance schemes along with its Stability Walk-In Chambers. Nagano Science also provides other related services such as Risk Assessment of customer’s stability storage facility and much more. For more details about NAGANO SCIENCE, please contact us: email@example.com
- Guidance for Industry, Quality Risk Management, Drug Office, Department of Health, US FDA
- ICH Q9 Quality Risk Management
- Aide Memoire, Assessment of Quality Risk Management Implementation