LABORATORY KNOWLEDGE. DELIVERED.™ LABORATORY …€¦ · LABVANTAGE Stability Module enables customers to: ... and custom protocols Create reports for studies and protocols in a

LABORATORY KNOWLEDGE DELIVERED™

BROCHURE TITLELABORATORY KNOWLEDGE. DELIVERED.™

LABVANTAGE® STABILITY

LabV

anta

ge Br

ochu

res

LabV

anta

ge® S

tabi

lity

2 of 11LABVANTAGE® STABILITY©2011 LABVANTAGE Solutions, Inc. All Rights Reserved. 1101JY25CYL

LABORATORY KNOWLEDGE. DELIVERED.™

Today’s challenge for many manufacturers is to meet both the FDA’s and the International Conference on Harmonization’s (ICH) guidelines. The intent of these guidelines is to clarify and raise basic testing standards. They are being incorporated by regulatory bodies around the world but especially in the US, Japan and Europe, and are helping to create a standardized regulatory environment worldwide. With this regulatory movement, the need for more, well-documented stability and shelf-life studies is paramount.

Stability and shelf-life testing ensures that products distributed to the public remain chemically and structurally unwavering once they are released. Stability protocols test:

▪ Potency of a product throughout its entire shelf-life to establish expiration dates ▪ Effects of packaging material combinations ▪ Effects of UV rays (products discoloration and etc.)

Companies in regulated industries, including pharmaceutical, contract services, health & personal, and food and beverage, have long been involved with stability testing due to the requirements stipulated in 21 CFR 211.

In addition, new industry sectors are now being required to perform stability testing, which is creating analytical challenges not encountered before. Suppliers of bulk active pharmaceutical ingredients (API) and raw materials manufacturers now must have stability data for their products. Manufacturers of vitamins and supplements with botanical ingredients, while not yet required to meet the same regulatory requirements as drug manufacturers, are finding it beneficial to have dependable stability data to back up their label claims and expiration dates.

LABVANTAGE Stability Module enables customers to:

▪ Automate shelf-life testing to provide evidence of expiration dates ▪ Automate the determination of product batch stability ▪ Automate label creation ad hoc or based upon scheduled pull dates ▪ Test raw materials, intermediate products and packaging components ▪ Generate shelf-life samples automatically and establish the specified times and numbers for product

pulls for each study ▪ Create pull lists including partial sample pulls to remove test samples at defined protocol intervals ▪ Provide considerations for the repetitive nature of study and sample selection ▪ Maintain information about products, conditions (challenges) and custom protocols ▪ Create reports for studies and protocols in a detailed or summary format ▪ Manage inventory tracking by container or raw units ▪ Delay or cancel individual conditions for each study ▪ Require approval by alternate users for study/condition changes ▪ Define the orientation of the container storage ▪ Simply cut, copy and paste information into a grid much like using Microsoft® Excel

Stability and Shelf-life teSting

LabV

anta

ge Br

ochu

res

LabV

anta

ge® S

tabi

lity



LabV

anta

ge Br

ochu

res The greatest strength of the Stability Module lies in its utilization of the workflow automation capabilities

inherent in LABVANTAGE. The ability to automate the steps of the process through the life of a study, regardless of the length of the study (five days or five years), is vital for maintaining traceability and accountability. The graphic below provides a quick overview of how LABVANTAGE provides a step by step process automation across multiple disciplines.

Stability and Shelf-life teSting (Cont’d)

LabV

anta

ge Br

ochu

res

LabV

anta

ge® S

tabi

lity



In the LABVANTAGE Stability Module, laboratories establish protocols that define a study’s required time interval, conditions, chamber management and testing to be performed at each specified time interval. Specifically, LABVANTAGE accounts for the following requirements in a stability protocol:

▪ The nature and intended use of the product ▪ Package/component material description and source ▪ Method of manufacture/sterilization ▪ Description of the type, size, and number of batches ▪ Placement and orientation of unit storage ▪ Storage conditions/parameters ▪ Time-points where analysis will be performed (e.g. baseline, 3 months, 6 months, etc). ▪ The number of duplicate samples to be created ▪ Analysis specific to the attributes and uses of the product, including package integrity, pH, sterility,

toxicity, weight loss, and chemical content/potency ▪ Acceptance criteria

Setting Up a protoCol or StUdy

LabV

anta

ge Br

ochu

res

LabV

anta

ge® S

tabi

lity



STUDY MANAGEMENTCreating and editing existing studies is accomplished through LABVANTAGE’s intuitive browser interface. The LABVANTAGE Stability Module:

▪ Enables automatic, configurable assignment of studies ▪ Captures study justification ▪ Tracks study status that automatically changes with the conclusion of the study. Statuses include

Running, Suspended, Completed, or Cancelled ▪ Can flag studies that have been modified by addition/subtraction of time points and/or conditions. ▪ Allows the quantity of samples per sample pull to be entered so that the tests may be completed. ▪ Allows the actual quantity received for the study to be specified ▪ Provides the ability to adjust the quantity by whole percentages that would increase the required

quantity to account for the possibility of retesting during the study ▪ Provides a theoretical “available quantity” that is determined by subtracting the quantity required for

testing from the actual total quantity submitted ▪ Tracks the quantity put in each chamber location for a study

StUdy ManageMent

LabV

anta

ge Br

ochu

res

LabV

anta

ge® S

tabi

lity



The daily scheduler built into the LABVANTAGE Stability Module has the capability to automatically generate the required samples or ‘‘pulls’’ as defined in the time-interval-condition matrix. In particular, LABVANTAGE provides the ability to:

▪ Schedule automatic sample logins based on the protocol’s selected time points ▪ Track a sample once it is logged and the time it takes to complete testing ▪ Notify designated person(s) if the time to complete testing is greater than the predetermined testing

period. ▪ Reconcile holiday “pull” decisions

SChedUle ManageMent

LabV

anta

ge Br

ochu

res

LabV

anta

ge® S

tabi

lity



Plans for handling variances can be documented in a standard operating procedure tracked in LABVANTAGE that includes corrective actions. When excursions are observed, analysis by a subject matter expert as to the probable effect on the stability of the product can be entered into the solution. At the data point following the excursion, the subject matter expert can enter a conclusion and recommend that the study either continue or be terminated. The LABVANTAGE Stability Module enables organization to:

▪ Identify batches, sub-batch by lot #, location and date ▪ Provide full traceability on finished goods to sub-lot level ▪ Ensure FDA 21 CFR Part 11 electronic signature compliance, with audit history ▪ Access the solution remotely (virtual user) via a browser - no Citrix required ▪ Create multi-tiered and nested specifications ▪ Integrate barcode labeling ▪ Seamlessly integrate robust reporting ▪ Create ad-hoc samples with and without formal requests ▪ Highlight early warnings and real-time non-conformance ▪ Monitor quality incidents ▪ Enter different styles of results, including single sample and multi-sample ▪ Review/edit samples at login including: actual collection date versus scheduled, test parameters, due

date, priority, etc. ▪ Check against multiple sets of specifications ▪ Check against process/regulatory limits

QUality & SaMple Control

LabV

anta

ge Br

ochu

res

LabV

anta

ge® S

tabi

lity



The business intelligence capabilities in the LABVANTAGE Stability Module are extensive and flexible enough to support virtually any reporting requirements. A complete compilation of stability data including the original approved protocol, incubation charts, daily readings of temperature and humidity conditions, test data and a summary of the stability parameters can be reviewed. Periodic review of testing performed throughout the study can be done to assure that acceptance criteria are being met throughout the duration of the stability program. For example, through the embedded reporting tool, organizations can configure reports to track:

Active/Status StudiesThe Active/Status Study report highlights all currently active studies and allows sorting by study identifier, status, batch, or lot.

Completed StudiesThe Completed Study report displays all completed studies and can sort by study identifier, batch or lot.

Pull Samples ReportA Pull Samples report displays all studies that need to have samples pulled for testing and can be sorted by assigned analyst or laboratory. The report can include daily pulls, weekly pulls or monthly pulls.

INTEGRATION WITH LIMSImportant for specialized stability and capabilities is the integration of the LABVANTAGE Stability Module as part of LABVANTAGE laboratory information management solution (LIMS). Integration in one solution provides complete stability functionality coupled with full automation, sample management, and the ability to leverage data interchangeability without duplicating data or third party system integration. For more information about LABVANTAGE, please download the LABVANTAGE Brochure at www.LABVANTAGE.com.

reporting & integration with liMS

LabV

anta

ge Br

ochu

res

LabV

anta

ge® S

tabi

lity



LABVANTAGE Solutions, Inc. is an innovative global provider of enterprise solutions tailored for leading laboratories. We serve numerous laboratories focused on:

▪ Research & Discovery ▪ Development (including Life Sciences Pre-clinical & Clinical Development) ▪ Formulation & Process Research ▪ Raw Material Testing ▪ Quality Management

Our global customer base encompasses companies across multiple industries including:

▪ Pharmaceutical & Biosciences ▪ Health & Personal Care ▪ Food & Beverage ▪ Process Chemicals ▪ Petrochemicals ▪ Parts, Hardware & Equipment ▪ Law Enforcement & National Security ▪ Contract Services

LABVANTAGE is a thin-client Laboratory Information Management Solution (LIMS) tailored to manage an organization’s critical laboratory information across its worldwide R&D pipeline and manufacturing supply chain in order to optimize productivity and more effectively share knowledge.

Headquartered in Somerset, New Jersey, United States, LABVANTAGE also has offices in High Wycombe, United Kingdom and Kolkata, India, and utilizes a strategic network of global business partners to provide regional sales and customer support.

LABVANTAGE is a privately held affiliate of The Chatterjee Management Group Company, a $1.5 billion private investment group that invests globally in infrastructure, communications and information technology companies.

LABVANTAGE OVErViEw

Www.labvantage.comAUSTRIA • BELGIUM • CANADA • CHINA • DENMARK • ESTONIA • FINLAND • FRANCE • GERMANY HONG KONG • INDIA • JORDAN • LATVIA • LITHUANIA • LUXEMBOURG • MALAYSIA • NETHERLANDS NORWAY • OMAN • QATAR • SAUDI ARABIA • SINGAPORE • SOUTH AFRICA • SWEDEN • SWITZERLAND TAIWAN • THAILAND • UNITED ARAB EMIRATES • UNITED KINGDOM • UNITED STATES

LABV

ANTA

GE Br

ochu

re

www.labvantage.com©2011 LABVANTAGE Solutions, Inc. All rights reserved.

For information regarding this and other LABVANTAGE products, please contact LABVANTAGE Solutions, Inc.: The information contained in this document is proprietary and confidential to LABVANTAGE Solutions, Inc. No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying and recording, for any purpose, without the express written permission of LABVANTAGE Solutions, Inc.

This document is subject to change without notice, and LABVANTAGE does not warrant that the material contained in this document is error-free. If you find any problems with this document, please report them to LABVANTAGE in writing. LABVANTAGE®, Evergreen Studio™, Evergreen™, LABVANTAGE Solutions Matrix™ and the LABVANTAGE solution icon are trademarks of LABVANTAGE Solutions, Inc. All other trademarks are property of their respective owners. This document may contain statements concerning possible functionality for LABVANTAGE software products and technology. LABVANTAGE disclaims any express or implied commitment to deliver functionality or software unless or until generally commercially available. Any statements of possible future direction are for information purposes only, and LABVANTAGE makes no express or implied commitments or representations concerning the timing and content of any future functionality or releases.

Documents

LABORATORY KNOWLEDGE. DELIVERED.™ LABORATORY …€¦ · LABVANTAGE Stability Module enables customers to: ... and custom protocols Create reports for studies and protocols in a