Streamline the Product

Registration Tracking
Process
Overcome Compliance Challenges and
Improve Visibility
3 Introduction

4 Navigating Regulatory Requirements

6 The Regulatory Imperative

7 Challenges within the Product Registration Process

9 Adopting an Enterprise Approach to Registration Tracking

10 The Value of Automation

Introduction
The chemical industry generates $3 trillion in annual revenues and provides ingredients and raw materials to over 70,000 different products
including pharmaceuticals, pesticides, plastics, paints and coatings, personal care products and cosmetics, just to name a few.
Globalization, mergers and acquisitions, increased competition and tighter regulations have impacted the chemical industry. To remain
competitive, organizations are looking at their current processes and identifying where they can reduce risk and create more transparency.
Moreover, companies are seeking opportunities to gain efficiency from limited resources.
One process that has come under scrutiny for chemical manufacturers is the product registration process. The process is complex and the scope
is global. The management of product registrations involves testing, documentation and submissions at the international, state and even local
levels. Any delays or errors in this process can result in lost revenue and increased compliance cost.

This paper highlights current global regulations, identifies the key challenges of the product registration process, and how streamlining the
process can significantly reduce delays, errors and unnecessary costs for a products launch and distribution.
Navigating Regulatory Requirements
Chemical ingredients and products in the United States (US) and the European Union (EU) are
receiving more attention and scrutiny from legislators and environmental regulators alike.
These regulations affect the sale, import and export of chemicals and the products that
contain these chemicals to ensure public and environmental safety. US Federal Approval Process
for New Chemicals2
In the United States, the Toxic Substances Control Act (TSCA) was passed in 1976 to provide
the Environmental Protection Agency (EPA) the power to review and regulate any chemicals 1 Chemical Innovations
being distributed in the US. Today more than 84,000 chemicals1 are regulated by the TSCA.
Receive Extensive Review
Pre-manufacturer notification and new product registrations must be submitted to the EPA
Central Data Exchange, which is the agencys electronic reporting site. Products imported into 2 EPA Examines
the US must be accompanied by certification stating that the chemical complies with TSCA Company Data
requirements or be denied entry into the US. By 2010, regulatory requirements were
segmented and it became difficult for companies to ensure compliance.
3 EPA Experts use
In response to outdated TSCA regulations, the Chemical Safety Improvement Act (CSIA) was Predictive Models
introduced to Congress in 2013 to enact reform and promote safety and innovation. It is a
science-based process that evaluates the safety of all chemicals in commerce, even those
grandfathered chemicals that had not been reviewed under TSCA. The EPA regulations
4 EPA Analyzes
would take precedence over individual state laws to ensure consistency, but a waiver would be Chemicals Properties
considered based on individual situations. CSIA is still being reviewed by Congress.
5 EPA Analyzes
There are also individual state programs to regulate chemicals used in consumer products. For
Exposure Potential
example, in California there are two local requirements that enforce chemical safety in
consumer products known as the Green Chemistry Initiative and the Department of Toxic
Substances Control (DTSC). Staying on top of the variety of US regulations for this industry is 6 Extensive Process
very challenging. Leads to EPA Decision

1 TSCA Chemical Substance Inventory. www.epa.gov/oppt/existingchemicals/pubs/tscainventory

2 Source: Rigorous Federal Approval Process Exists for New Chemicals 2012 American Chemistry Council, Inc.
 Navigating Regulatory Requirements
In 2007, the EU enacted the Registration, Evaluation, Authorization and
Restriction of Chemicals (REACH) which requires any chemical exceeding one ton
be registered and data submitted on the chemicals identity, production process,
usage instructions, safety guidance, and effects on human health and the
environment to the European Chemicals Agency (ECHA). For quantities above 10
tons additional testing information on environmental hazards, toxicity pollution $32
Billion
assessments and other long-term hazard analysis must also be submitted.

In Europe, there are over 14,000 registered substances, more than 3,100 pending
registrations, and another 13,000 chemicals that have been produced or imported Costs to implement REACH
that meet the volume requirements.
The EU Commission has estimated the total
Under the REACH evaluation process, ECHA reviews the testing proposals and REACH implementation costs to be incurred
compliance verification of the active ingredient or products registered and a risk by industry could cost up to $7.0 billion.
assessment is performed. Any substances considered high concern cannot enter
the EU market unless authorized in the registration of the active ingredient or the However, other studies have indicated that
mixture of the indicated product. Any chemical over the one ton requirement the total direct and indirect costs
needs to be registered under REACH between November 2010 through May 2018,
with timing based on the volume and toxicity levels of the substance. associated with REACH implementation
could reach as much as $32 billion.2
EU Registration Deadlines1

2007 2008 2010 2013 2018

1 Jun 1 Jun1 Dec 30 Nov 31 May 31 May

REACH entry Pre- 1000 tonnes and 100-1000 1-100 tonnes
into force registration very toxic to tonnes
aquatic organisms

1 Guidance on Registration ECHA European Chemicals Agency. Version 2.0. May 2012
2 EU REACH and U.S. Regulation of Chemicals and Chemical Users white paper. National Electrical Manufacturers Association (NEMA). May 2007.
The Regulatory Imperative
In order to distribute their products, Chemical manufacturers must ensure compliancy
with global and local regulations and provide the required testing and reporting to
validate chemical products, their safety and efficiency, and accurate labeling Visibility is Critical
specifications. In the event that a substance is considered hazardous by a regulatory
Changes in formulation, indication, packaging
agency, the manufacturer or importer is required to prepare an exposure assessment
and labeling requires an organization to re-
and risk characterization, which could impact the chemicals documentation - i.e.
register an active ingredient and any
Safety Data Sheet (SDS) - and labeling resulting in a delay in distribution.
corresponding products.
Furthermore, as pre-commercial products mature through the product development
cycle, registration activities must be well-planned and executed to ensure compliance Since this information is often stored in
requirements are met before products leave the facility. spreadsheets and paper-based files, updates
may go unnoticed by RA employees who are
Within this challenging environment, organizations are counting on Regulatory Affairs not part of the process.
(RA) staff to track and manage product registration requirements on a constant basis.
Lack of visibility into quality
Monitoring national, federal, state and local regulations is a challenging task for the AUDITS processes can result in
RA team, usually comprised of only a few people. Juggling pre-registrations of new
compliance issues, fines,
products, re-registration of products from M&A activities, and managing and updating
quarantined product and lost
existing registrations on a bi-annual or annual basis is difficult enough domestically.
CAPA revenue.
Add the complexity of monitoring international regulatory requirements in over 100
countries for all active ingredients and their corresponding products and you have a By integrating all quality data
situation with a high probability of errors and missed deadlines leading to distribution into one central repository, like
delays and possible missed revenue. a Quality Management System
CHANGE (QMS), email alerts and
MGT
The product registration process and the constant communication and tracking of notifications can be sent to RA
deadlines takes a considerable amount of time and effort. As a result, companies are managers to update existing
seeking new ways to streamline the registration tracking process and many chemical registrations.
manufacturers have chosen to outsource the registration to an outside firm that
specializes in regulatory support and registration management.
Challenges within the Registration Process
Many companies maintain manual processes which result in challenges in timely and accurate
tracking of activities. As a result there is limited visibility into the status of a registration. This can be
further compounded if an organization has outsourced all or part of its registration process. One
delay or missed deadline can lead to a product being quarantined or denied approval to import into
a specific country, which could impact sales and provide an opportunity for competitors to capture
market share.

Companies must overcome key challenges in order to automate and streamline the product
registration process. Chemical Pesticide
1. Data Overload
Registration Requirements*
Imagine a global chemical company needs to register an active ingredient and its corresponding
finished products to ensure global regulatory compliance. That requires a series of different tests for 70 specific tests with
each product to be managed and documented using paper-based records and a spreadsheet list to documented results for each
track outstanding tests. There could be hundreds of tests tracked against 20 different registrations, ingredient and product
resulting in thousands of different transactions and data points. That doesnt include the multiple
communications between various global regulatory agencies, which results in tens of thousands of $10 million in registration fees
touchpoints in the process. The cost to register products with each country or state can cost millions
Review process takes over 2
of dollars in registration fees, and can take years to review and approve.
years
Most manufacturers struggle to maintain and track this amount of data with regulators worldwide.
Imagine registering one active ingredient and the 20 new products using the ingredient with over 80
regulatory agencies worldwide thats over 1,600 registrations over a number of years.
Furthermore, If an RA employee leaves the company, it could take months to replace and retrain a
new employee to manage these registrations, resulting in delays and missed deadlines that impact
multiple product launches.

* Environmental Protection Agency (EPA) Registration Division. New Actives

Ingredients. http://www2.epa.gov
Challenges within the Registration Process
2. Siloed Information
Often times when product registration is submitted, it remains in spreadsheets or paper-based records and is forgotten until
there is a status update. Often that product registration is not integrated with the manufacturers change control process,
which could impact the registration approval of the product. For example, if a chemical substance is made in a facility and the
specifications of the product are consistently out of spec (OOS), then a change request will be issued to update the standard
specification. If the change is not made to the registration, it could potentially prevent a product from being distributed. As a
result, RA managers must constantly investigate across silos of information and disconnected processes to identify changes that
have taken place and whether a revision is required to the original submission or new registration must be submitted.
If the registration management process is outsourced to an outside firm, the lack of transparency is even greater. Data is
transferred periodically between the manufacturer and the registration affiliate through emails or phone calls and it is difficult
to control when registrations are being reviewed and updated.
3. Lack of Data Integrity
Registration data and processes are usually maintained in paper-based records or spreadsheet files saved in a shared drive
accessible to other employees in the department. However, the lack of control over documents and changes made by different
employees increases the risk of noncompliance. Auditors question the validity of a manufacturers product registrations when
there is uncontrolled access to the spreadsheets and changes to the data are not tracked properly.
In this scenario, companies need to utilize a registration tracking system that documents all updates to a specific record, as well
as the date and the employee making the change. This provides a documented view of the entire pre-release product lifecycle
including corrective actions or management of change (MOC) prior to a release. Companies need to establish a single source of
truth to ensure they are making decisions based on current information and can prove compliance to regulators.
Adopting an Enterprise Approach to Registration Tracking
The product registration process in the chemical industry is both global and local. RA professionals must ensure compliance with local
regulations and maintain global visibility and control over product registrations. This can be facilitated through an enterprise-wide approach to
product registration tracking and related processes that leverage automation and system and process integration.
Instead of tracking hundreds of product registrations in spreadsheets or paper files, leading companies are leveraging software to automate the
tracking and managing of each regulation, its registration date, and required submission information and documentation. In the event of missing
information, automatic alerts can be sent to assigned employees to follow up and coordinate with the regulatory agency to meeting compliance
requirements.
In order to obtain the global visibility and control with internal and external parties that are currently missing from this process, organizations
implement a centralized solution that allows all users, both internal and external, to enter registration updates, testing results, and changes to
provide real-time updates to avoid launch and distribution delays.
Leading companies are also leveraging automation and analytics and reporting capabilities to easily run comprehensive reports and dashboards
that display the status of registrations and can be used to identify and address potential concerns (i.e. expiring registrations and pending
commitments) before they become major issues.
Assigned users can also easily query the system to locate test results, QSAR/QSPR studies, toxicology tests associated with a particular substance,
and transmit documents electronically to regulatory bodies. Submission information including date, documents and correspondence is
recorded and date submissions can automatically be recorded to document compliance requirements.
In the event that a chemical company manufacturers or imports more than 10 tons (or other specified quantity) of a controlled substance per
year, an alert can be sent to the regulatory and product team to supplement registration information with required chemical safety assessment
to define risk and operational control conditions. A pre-configured workflow with trigger reminders or notifications when certain threshold
requirements are met or exceeded help ensure compliance in the consumer marketplace.
The Value of Automation
Systems and Data Integration
An ideal function for a product registration tracking solution is that it should integrate with a manufacturers core business systems
such as an ERP or LIMS and automatically pull the required data for product registrations. This allows for the RA manager to quickly
and accurately fulfill regulatory requirements. It eliminates the need for manual data entry and ensures that regulatory affiliates are
using accurate, consistent and up-to-date information when registering or re-registering products or making changes to existing
product registrations.
A product registration tracking solution should also directly integrate with the manufacturers global change control process so that it
can alert users to product changes that may affect registration and correspondence activities. Ideally the solution should also
automatically generate registration and correspondence records required to update registrations in those markets impacted by the
change. In addition, the solution should integrate with the manufacturers document management system, publishing and submission
software, and safety reporting system, as well as provide users with electronic access to original documents so that correspondence
with regulatory authorities and outside testing facilities can be managed and tracked effectively.
Increase Visibility Internally and Externally
In order to manage issues and changes proactively, manufacturers understand the importance of developing and implementing
internal audits in manufacturing facilities. Whether it is Environmental Health & Safety (EH&S), Hazard Analysis audit within the
production area, or Maintenance & Repair Operations (MRO), identifying potential problems earlier in the process and implementing
changes to prevent issues in the future reduces the impact on product costs and the risk level associated with the facility and the
finished product.
The lack of visibility into the supplier and contract manufacturer network adds even more risk especially since regulators are
expecting the manufacturer to ensure supplier compliance as well. Poor quality and lack of visibility into supplier processes can cost
chemical manufacturers more than ten times the cost of the product to fix the issue. If it makes it out to the market and results in
quality and safety issues, it can cost a company 1000x the cost of the product and could result in fines, lawsuits and scrutiny from
regulators.
The Value of Automation
Chemical manufacturers are enforcing internal and external audits to ensure compliance across the entire supply chain. By
automating the management and scheduling of audits, manufacturers create a standard operating procedure to proactively identify
issues before they can impact production. It also provides the documented compliance history that regulators are looking for during
an on-site audit.
A solution that enables auditors to use mobile devices to record findings via an electronic checklist streamlines the recording process
and allows images to be taken onsite and saved in the audit record for future reference. Completed audits should be uploaded in a
central repository to share findings with the internal team so investigations and corrective actions can be implemented to resolve
issues.
An integrated analytics dashboard can report on data stored in the repository to view internal facility issues or supplier and contract
vendor trends that may affect the quality or safety of the finished product. In the event that a supplier is identified as high-risk and an
alternative supplier is selected, the product registration for any product containing the new suppliers ingredient must be reviewed by
the RA manager to ensure compliance either with the registered product or the sourced ingredient from the new supplier.
Increase Productivity and Cost Efficiencies
Through process automation and data consolidation, RA professionals can eliminate most of the manual tasks currently associated
with the product registration process, reducing administrative costs and enabling them to reassign resources to more value-added
activities within the organization. When the organization knows exactly which product registrations are due at what time, RA
professionals can evaluate the available resources in those markets, determine the necessary manpower for meeting upcoming
deadlines and assign necessary resources.
With a single centralized system, RA professionals can store and share global product information across the enterprise. This reduces
costs by eliminating redundant technology applications and the information technology (IT) resources required to maintain and
manage multiple systems.
Conclusion
RA managers in the chemical industry carry a tremendous burden. They secure and maintain the necessary approvals from regulatory authorities
which play a pivotal role in a companys success ensuring products can be sold in the global marketplace. Those products that inadvertently
slip into a state of non-compliance put companies at a great financial risk. The processes involved in product registration tracking are far from
simple. They involve keeping up to date on the latest guidelines, regulations and timelines set forth by regulators across the globe. The
cumbersome tracking of correspondences and commitments and understanding when product changes impact registrations is difficult to
manage using spreadsheets and paper-based records.

New software technologies help RA managers manage the activities of internal team members and third party affiliates to ensure everyone is
following the correct procedures, performing the necessary tasks and meeting deadlines. Automation also helps drive down costs associated
with inefficiencies, errors and waste, and helps organizations enhance and improve their product and operational risk management strategies.

While the finance department uses an ERP system and the production team leverages the MES systems, the RA department has been manually
typing data into spreadsheets and keeping paper records on registrations and follow up communications. As a department critical to the success
of a chemical manufacturers operations, Regulatory Affairs needs a solution that enables global visibility of the registration process and control
over the local activities for each market in which its company sells products. An enterprise-wide approach to product registration tracking that
integrates with change control, correspondence and commitment tracking eases the administration burden, and enables RA professionals to
work with greater efficiency and accuracy while reducing the costs and risks for the organization.
Resources

To learn more about how an enterprise quality management solution can support
manage processes inside and outside the four-walls of an organization to reduce
costs and increase operational efficiencies, check out these resources

Case Study: Global Agrochemical Company Maintains Compliance with TrackWise

EQMS

eBook: Four Best Practices to Improve Quality in the Supply Chain

Whitepaper: Quality Management in the Complex Manufacturing Environment

Sparta Systems, an industry pioneer and global
leading provider of enterprise quality management
software (EQMS) solutions, enables businesses to
safely and efficiently deliver their products to
market. Its TrackWise EQMS, a trusted standard
among highly regulated industries, is used by
quality, manufacturing and regulatory affairs
professionals to manage compliance, reduce risk
and improve safety across the global enterprise.
Headquartered in New Jersey and with locations
across Europe and Asia, Sparta Systems maintains
an extensive install base in the pharmaceutical and
biotechnology, medical device, electronics
manufacturing and consumer products markets.

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