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NEW MANUFACTURING FACILITY FOR ONCOLOGICAL INJECTABLE DRUG

PRODUCTS GOES LIVE WITH PAPERLESS VALIDATION



The Challenge: Quick Validation Ramp-Up to Exploit New Market Opportunity
filling, lyophilization, packaging, and storage. The oncological
production line will produce liquid and lyophilized vials. A
separate, isolated area will house equipment for prefilled syringes
dedicated for non-cytotoxic products.

The company needed an electronic validation management
system for the efficient and consistent creation, review, revision,
and sign-off of validation documents required during the
construction of the new facility, estimated at more than 2,000
documents initially. ScinoPharm hoped to implement a fully
electronic system that could eventually be scaled to its existing
facilities and locations. The broader scope will include enforcing
validation standards and procedures that are typically buried in
approved validation master plans, SOPs, and policy documents.

Getting a new facility up and running
required extensive development, review,
revision, and approval of validation
documentation. We wanted to avoid mounds
of paper and minimize signoff time, but we
saw a lack of functionality related to the
validation process offered by traditional
document management systems. We found
what we needed in ValGenesis.


Steve Johnson, Director, Operations
Injectable Facility
ScinoPharm Taiwan, Ltd.



Following the rapid implementation of the ValGenesis Validation Lifecycle Management System (VLMS), ScinoPharm is
managing the validation of its GxP assets 100% electronically to remain on schedule for construction of its new high
potency cytotoxic injectable plant. The facility will enable a new business area for the company and a broader way to
serve existing active pharmaceutical ingredient (API) customers. The initial ValGenesis implementation ensures
compliance for the facility, utilities, and equipment to support manufacturing in effect, validation from the ground up.

THE SOLUTION:
Validation Lifecycle Management for Now and the Future

ScinoPharm had met with vendors of document management systems offering the
promise of validation support. But the company saw no evidence of the out-of-the-box
functionality provided by ValGenesis for validation planning, requirements
management, risk management, test execution, scheduling, and change management.
Continue

From research and manufacturing facilities in Taiwan and China,
ScinoPharm provides a range of services to the global
pharmaceutical industry, including custom synthesis for early
phase pharmaceutical activities to brand companies and APIs for
the generic industry. With its decision to build an injectable
facility for high potency cytotoxics, the company will offer a
vertically integrated, one-stop-shop service for API customers.

This opportunity for growth stemmed from a global demand for
oncological injectable production capacity that far exceeds the
current supply. ScinoPharm must build quickly, but with strict
vigilance to the regulatory and international cGMP standards for
the sterile facility. The $US 50 million facility will include space
for R&D, quality control, washing, sterilization, manufacturing,

The Implementation: Collaboration Across the Globe for 21 CFR Part 11 Compliance
Continued ValGenesis offered a holistic solution for Validation Lifecycle
Management. It could deliver in six weeks from configuration requirements gathering to
go-live. But its most compelling advantages were in ease of use, training, and
maintenance. ValGenesis enables ScinoPharm to develop validation protocols and
requirements in MS Word and Excel while managing them electronically through
controlled workflows. All assigned alerts are routed through corporate email and provide
links to validation tasks through the dashboard. Users simply click on the hyperlink to
open the task and then author, execute, review, or approve.


ValGenesis was introduced to the CEO of ScinoPharm during an
impromptu in-flight business discussion. Fast forward a few
weeks, and the Director of Operations for the companys new
injectable facility had listened in on a series of ValGenesis client
calls and experienced some Web demos. The out-of-the-box
solution offered much more than a retrofitted document
management system. Three months later, the companies had
agreed on a scope of work for an initial project to enable the
development, review, revision, and approval of more than 2,000
documents associated with the validation of the new facility.

The ValGenesis Implementation, Validation, and Support teams
worked with the ScinoPharm designated administrator to
configure the system as needed. Steps to ensure 21 CFR Part 11
compliance were completed and tested in record time: the User
Requirements Specification and compilation and execution of the
Installation Qualification (IQ), Operational Qualification (OQ),
and Performance Qualification (PQ).

The implementation was completed in six weeks. During a
conference room pilot, the group signed off, and the new system
was moved into production.

In the following months, ScinoPharm wrote standard operating
procedures (SOPs), curricula, and tests for system training,
relying heavily on the videos available from ValGenesis. Eight of
the 25 employees working on the project are core users, and
additional users come onboard each month.

ValGenesis provides real time validation metrics. Users are able
to take snapshots of the validation process and gauge overall
productivity: How effective is a particular department, group, or
user? How many GxP systems have been validated or are in
process? ValGenesis reveals bottlenecks, schedules alerts, and
helps ScinoPharm keep to its rigorous schedule for the input of
more than 2,000 documents required during the initial facility
commissioning and qualification.

Following a smooth rollout, users are on target for their project
deadline. Once the project for the new facility is completed,
ScinoPharm plans to extend usage of ValGenesis to an additional
site in Taiwan and eventually to operations in mainland China.
ValGenesis delivered a validated and qualified system in six weeks the rapid implementation we
needed. The system has been stable from the start, with little need for customer support calls, allowing
us to focus on training and bringing on new users every week.
Steve Johnson, Director, Operations
Injectable Facility
ScinoPharm Taiwan, Ltd.



THE RESULTS:

A 100% electronic approach to Validation Lifecycle
Management from the ground up for a new facility
requiring strict adherence to regulatory and international
cGMP standards.

Convenient, real-time, site-level access for the
authoring, execution, review, and approval of GxP assets
for facility and equipment validation (including the
strategic plan, facility requirements, initial assessment,
commissioning plan, acceptance reports, installation
validation, functional testing plan, operation data, and
matrix and release reports).
A multi-tenant, web-based system accessible from
almost anywhere. Easy virtual collaboration, visibility,
accountability, and time savings through simultaneous
review and approval of validation documents by various
stakeholders. Electronic workflows supported by
automatic audit trails and electronic signatures.

Document consistency via templates while enforcing
validation standards and policies according to approved
validation master plans, SOPs, and policy documents.

The potential to scale, incorporating additional facilities
and eventually integrating change management
applications.
ValGenesis, Inc
42840 Christy St. | Suite 102, Fremont, CA 94538
Phone: 1-888-825-4363 | (510) 445-0505
Fax: (510) 991-9901
www.valgenesis.com | email: info@valgenesis.com
Copyright 2014 ValGenesis, Inc. All rights reserved.