Risk Control For each of the two areas of significant risk identified in the FTAs andsummarized above, associated risk control plans were established. Tavaana Exclusive Case Study: All materials on our website are shared by users. Annex 2 WHO guidelines on quality risk management 1. The analysis was organized into the fault tree structure depicted below in Figure 1.

This presentation is the opinion of the presenter, and does. Annex 2 WHO guidelines on quality risk management 1. Risks associated with equipment parts changes that might adverselyimpact the validated state of manufacturing equipmentRisks associated with the process of determining whether srcinal andreplacement parts are functionally equivalentProper roles and responsibilities of the functional areas involved in theprocess of determining whether srcinal and replacement parts arefunctionally equivalentThe outputs of the risk management approach utilized by the firm included ageneric, robust, and repeatable process for performing functional equivalenceassessments as well as definition of organizational roles and responsibilitiessupporting the process. An example checklist from the Engineering functional area is shown below in Figure 3 Figure 3 — Engineering Functional Equivalence Determination Checklist Areas of Consideration Materials of construction and ratings Composition of process-contact parts Compatibility with process Surface finishes Typical Characteristics of Functionally Equivalent Parts Assessment Performed By Comparable materials of construction for wetted surfaces Parts designed to operate at expected process extremes heat, pressure, chemistry, etc. However, it is not uncommon for pharmaceutical manufacturers to resort to procuring and installing replacement parts that are not identical to the original parts due to changes affected by parts suppliers product redesigns, discontinuations, etc. This column discusses scientific and regulatory aspects of aseptic processing, with an emphasis on aseptic formulation and filling. There is generally no single best choice for any given assessment process, and the selection of the appropriate risk methodology should be based on the depth of analysis required, complexity of the subject risk of concern, and the familiarity with the assessment tool.

Rather, inclusion here indicates that the example represents a perceived area of functiinal interest and a functional and actual example of risk management employed towards effective analysis, problem-solving and decision management.


Case_Study_RMWG_-_Functional_Equivalence_for_Equipment_Replacements_(rev_1) – Documents

Page 1 of 9. To use this website, you must agree to our Privacy Policyincluding cookie policy. All quality risk evaluations must be based on scientific and process-specific knowledge and ultimately linked primarily to the protection of the patient – Risk assessment is based on the strong understanding of the underlying science, applicable regulations and related processes involved with the risk under analysis.

November Revision Date s: In fact, it is the first risk that banks must manage, even before they make their first. During these service lifetimes manufacturing equipment will likely require both preventive and corrective maintenance activities that may involve the replacement of parts within the systems.

case study rmwg-o3 functional equivalence for equipment

Page 6 of 9. Helena Paulina Walker 3 years ago Views: A Life-Cycle Multi-Phase Approach Jackelyn Rodriguez This article provides a life-cycle methodology in a multi-phase sttudy that includes an effective More information. Please address any comments on this proposal, by 1 October to Dr More information.

Quality Risk Management Principles and Industry Case Studies – PDF

Each functional area checklist details unique areas of consideration for the assessment and provides spaces for the assessment conclusions and the signatures of the assessor s. As noted above, given size and complexity, the presented case studies are often redacted xase of the actual assessment.

Diagram 2 – Documentation Level. Risk based monitoring using integrated clinical development platform Risk based monitoring using integrated clinical development platform Authors Sita Rama Swamy Peddiboyina Dr.

The collected case studies demonstrate that there is a wide range of applications for the use of structured risk management analysis to facilitate effective quality decision activities. Team unanimously agreesthat these risks have low probabilities of occurring. Consent decree, product seizure, regulatoryimposed cessation of operations or equivalent. Casw Operating Procedure Title: Introduction ICH Q9 – Quality Risk Management provides an excellent high-level framework for the use of risk management in pharmaceutical product development functiona, manufacturing quality decisionmaking applications.

Annex 2 WHO guidelines on quality risk management 1. Training and qualification curricula for personnel initiating change controls where functional equivalence will be assessed Equipment change control SOPs that direct the functional equivalence assessment process for parts replacements Maintenance systems inventory process control flow Training is required to be performed on these updated documents and training records are periodically audited for compliance.


Identify potential gaps, inconsistencies, and redundancies within theprocess that had historically been used for replacement parts functionalequivalence determinations.

case study rmwg-o3 functional equivalence for equipment

Finally, once risks have been appropriately assessed and prioritized, clear risk mitigating actions must be defined, communicated, implemented and monitored for effectiveness. Nonetheless, the provided summaries are effective in demonstrating the general thought process, risk application and use of the chosen risk methodology without overcomplicating the example with the detailed line-by-line specifics of the actual assessment itself.

A few of the case studies evaluated made use of more than one risk analysis tool and, in one instance, a modified version of a standard risk methodology for purposes of simplifying the analysis. Risk assessment must take into account the probability of a negative event in combination with the severity of that event This principle also serves a useful working definition for risk i. These principles are aligned with, and in some instances expand beyond, those already defined by ICH Q9 and are included in this report.

Managing Clinical Trial Risk: Little Risk assessment is used as a vetting More information. In the selection of a Risk Assessment Method, it is recommended to evaluate the QRM process and to select the simplest tool available to support the process.

Case study rmwg-o3 functional equivalence for equipment

Incorrect functional equivalence assessment Technical Services: To make this website work, we log user data and share it with processors. Making great ideas into profitable. At this stage of the QRM process, fnuctional should be taken to not exclude those operations which may be simply perceived as low risk, without fully evaluating the actual potential influences and associated potential risks involved.