InstantGMP: Electronic Batch Records System for GMP Manufacturing

INSTANTGMP™INVENTORY CONTROL MODULE

FOR GMP MANUFACTURING

InstantGMP: Electronic Batch Records System for GMP Manufacturing

GMP: Challenges of Traditional Systems

Inventory control of GMP materials is a complex process.

Wide array of regulatory requirements

Time and expense needed to set up an automated system

Difficult to keep up with individual entries if system is not centralized and available to all users

Keeping track of depletions and shipments is laborious

Compliance can be resource intensive

InstantGMP™ has an inventory control module that was built from the ground up to meet these challenges

InstantGMP: Electronic Batch Records System for GMP Manufacturing

InstantGMP™ - A new approach to GMP manufacturing

Electronic Batch Records System for GMP Manufacturing

Seamlessly incorporates everything necessary for GMP manufacturing in one place

Cloud-based application makes all data visible to everyone at all times

Uses built-in quality procedures to make GMP compliance easy

Provides more flexibility, visibility and productivity than paper based manufacturing

InstantGMP: Electronic Batch Records System for GMP Manufacturing

Automated Compliance

cGMP compliance controls are built into the system Part numbers automatically assigned to all materials Materials quarantine/restricted until QA approval of

vendors and specifications Specifications system has automated version control Purchasing restricted to approved materials and

vendors Digital signatures at specified steps record person

and date/time Limited access based on user/role security settings Complete automated audit trail

InstantGMP: Electronic Batch Records System for GMP Manufacturing

Inventory Control Inventory use tracked at every transaction Part numbers assigned automatically Specifications management with version control Purchase requisitioning with quality checks built in Automatically generated purchase orders Material receipt and warehouse recording Quality status controlled only by QA Depleted inventory shows what materials have been

used up

InstantGMP: Electronic Batch Records System for GMP Manufacturing

Distributed Vendor Capability Company can use several vendors for

each of their materials Each vendor can enter individual

inventory updates for each item in inventory

System monitors who entered what and when

Company can track complete picture of inventory use, history and amount across multiple sites

InstantGMP: Electronic Batch Records System for GMP Manufacturing7

Tracking of Inventory Distribution

InstantGMP: Electronic Batch Records System for GMP Manufacturing

Summary

Inventory system includes control overMaterialsVendorsSpecificationsStatus and use

Can be used for materials distributed over multiple sites or vendors

Easy to use and visible to all authorized users over the web

InstantGMP: Electronic Batch Records System for GMP Manufacturing

Quick Facts Developed by the manufacturing and

quality experts at PharmaDirections Integrated internet based application

developed through “Quality by Design” approach

Standard Operating Procedures and Policies come with the application

21 CFR Part 11 Compliant System has been in use since 2004

InstantGMP: Electronic Batch Records System for GMP Manufacturing

InstantGMP™ Summary Electronic Batch Records system for GMP

manufacturing contains inventory control module Takes full advantage of cloud-based application 21 CFR Part 11 compliant database with SOP

requirements hard coded into the software Simplifies the documentation and approval procedures

to reduce time lines and increase visibility Ideally suited for any GMP manufacturing such as

APIs, drugs, OTCs, generics and dietary supplements For more information, contact:

JPittman@InstantGMP.com

InstantGMP: Electronic Batch Records System for GMP Manufacturing

InstantGMP™

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Supplements in the Resource Center at

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