InstantGMP Compliance Seriesfor cGMP Dietary Supplements

Improving Quality through In-Process Control

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

2

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

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

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

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

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

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

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

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

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

InstantGMP™

Thank you for visiting!

Find more presentations and videos on GMP Manufacturing in the Resource Center

at www.InstantGMP.com