InstantGMP Compliance Series - Improving Quality through In-Process Control
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Transcript of InstantGMP Compliance Series - Improving Quality through In-Process Control
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InstantGMP Compliance Seriesfor cGMP Dietary Supplements
Improving Quality through In-Process Control
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Electronic cGMP Manufacturing Execution System
Problems with In-Process Controls
• Warning letters issued to firms who failed to set and met in-process specs
• No specification for capsule weights could have negative impact on strength and composition
• No controls on blending times could result in variations from batch to batch
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Electronic cGMP Manufacturing Execution System
Why Controls Are Important
• It is impractical to do final testing on many dietary supplements products
• Meeting in-process steps ensures the final product will conform to end product specs
• Makes sure final product has correct identity, purity, strength and composition
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Electronic cGMP Manufacturing Execution System
Why Controls Are Important
• Detect any deviation or unanticipated occurrence that may result in a failure
• Provides ranges to stay within for critical operations
• Reduces risk of contamination
• Ensures the quality of the finished batch especially when end product testing is not required
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Electronic cGMP Manufacturing Execution System
Production Controls Include:
• COA from qualified suppler (except for dietary ingredient identity)
• Components that meet specifications
• Confirmation of component identity prior to use
• Confirmation of other specifications using either COA or by testing
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Electronic cGMP Manufacturing Execution System
Process Control System
• Covers all stages of manufacturing, packaging, labeling, and holding
• Makes sure product is packaged and labeled as specified in the master manufacturing record
• First step is to use high quality components with well-defined specifications
• Avoids risk of making adulterated product
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Electronic cGMP Manufacturing Execution System
In-Process Specifications
• Required for each process step where control is needed to assure quality
• Heating or cooling steps• Specific sanitation requirements• Product formulation steps• Points where cross-contamination may occur• Where hygiene is necessary to control quality
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Electronic cGMP Manufacturing Execution System
Tablet and Capsule Control
• Special controls when manufacturing tablets or capsules
• Prevent inclusion of foreign material using filters, traps, magnets, metal detectors
• Periodic checks on weights, tablet hardness, etc. throughout manufacturing
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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
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Electronic cGMP Manufacturing Execution System
InstantGMP™ - Our goal is to make GMP compliance easy
• Electronic cGMP Manufacturing Execution System
• Web-based application makes all data visible to everyone at all times
• Uses built-in quality procedures to make GMP compliance easy
• Provides opportunities for more flexibility, visibility and productivity
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Electronic cGMP Manufacturing Execution System
Benefits of Electronic Manufacturing
• More efficient than manual systems
• 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
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InstantGMP™
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