instantgmp compliance series - managing deviations for improved compliance
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InstantGMP Compliance Series
Managing Deviations for Improved Compliance
Electronic cGMP Manufacturing Execution System
Deviations
• Triggered by any unanticipated occurrence could result in adulteration
• Must be noted in batch record• Quality must conduct a material review• Then make a disposition decision• May not reprocess a batch that deviates unless
approved by Quality
Electronic cGMP Manufacturing Execution System
Problems with Deviations
• Warning letters issued to firms who failed to record and resolve production deviations
• One firm used ingredients other than the ones specified
• Another firm did not conduct an investigation of retested samples that failed specifications
• A firm claimed to have established deviation procedures, but provide no documentation
Electronic cGMP Manufacturing Execution System
Why Managing Deviations Is Important
• Intention is to make uniform, high quality products• Deviations may indicate product is not under control• May indicate that master formula may need updating
based on variations in raw materials or dietary ingredients• Quality needs to review and disposition each deviation• Lets an independent quality group make sure product that
reaches the market is free from defects
Electronic cGMP Manufacturing Execution System
Definitions
• OOS – Out of Specification• CAPA – Corrective and Preventive Action• Corrective Action – eliminate cause of an
existing undesirable situation in order to prevent a recurrence
• Preventive Action – eliminate the cause of a potential undesirable situation in order to prevent an occurrence
Electronic cGMP Manufacturing Execution System
Out of Specification
• OOS - any value that does not meet the acceptance criteria of a specification
• Triggers an investigation plan• Initial phase - the laboratory results are challenged by
retesting and comparing to a retain sample to • Second phase - investigation of the manufacturing
processes • Quality must make a disposition decision and decide
whether the batch is OK or should be rejected
Electronic cGMP Manufacturing Execution System
Investigations
• Investigations may be initiated due to:– Confirmed Out-Of-Specification (OOS) results– Out-of-Trend (OOT) - atypical results that deviate
from expected or historical data, but still meets specifications
– Failure of a component, excipient or in-process test– Unplanned disruption in production – Unplanned deviations from approved procedures,
methods or specifications
Electronic cGMP Manufacturing Execution System
Corrective and Preventative Actions
• CAPA log needed for recording deviations• Identify the specific deviation or unanticipated
occurrence• Describe the investigation• Evaluate whether or not the deviation resulted
from or could lead to a failure• Identify actions to correct and prevent a recurrence
Electronic cGMP Manufacturing Execution System
Determine the Scope
• Scope includes:– time frames during which the problem occurred– number of times the problem occurred– the number and identity of products or materials
involved– locations (including vendors) involved.
• Determine the relevant events leading up to and surrounding the event. Determine what happened, how it happened, and who, when and where.
• Clearly define the problem
Electronic cGMP Manufacturing Execution System
Determine Root Causes
• Determine possible and probable causes of the problem• Determines why the problem occurred• Root causes will typically fall into one of three categories:
– System design: Are procedures sufficient? Are other process components sufficient (materials, equipment, facilities, personnel).
– System implementation: What does, or can management do to ensure that procedures are followed?
– Performance: Is this an individual performance issue?
Electronic cGMP Manufacturing Execution System
Determine Corrective/Preventive Actions
• Use various tools and techniques, such as brainstorming, cause and effect analysis and statistical tools
• Involve people closest to the problem• Select the most effective or cost effective
corrective/preventive action• Document justifications
Electronic cGMP Manufacturing Execution System
Develop CAPA Plans
• Redesign systems and processes• Implement remedial training is needed, • Assure that there is no further performance of
the task until the necessary re-training is complete
• Set target dates and assign individuals responsible for implementation
• Use measurable outcomes to evaluate the effectiveness of the preventive actions
Record Deviations in Batch Records
Electronic cGMP Manufacturing Execution System
Benefits of Electronic Manufacturing
• More efficient than manual systems• Shrink or eliminate redundant processes and forms• Trim time and overhead costs• Reduce errors, omissions and deviations• Provide opportunities to reorganize and update
processes• Increases throughput, quality and margins
InstantGMP™
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