Founded in 1984, Walthers & Associates
(W&A) provides cGMP Validation Services to the pharmaceutical and related industries.
Since that time, experience and in-depth involvement in this area has led us to branching
out into additional areas of this dynamic field. We provide services to the
pharmaceutical, biotechnological and medical device industries in the following areas:
Validation Assessment Audits
Validation Master Plan Preparation
IQ/OQ/PQ Protocols and Testing
Computer System Validation
Standard Operating Procedure Development
Functional Specification Development
System Design Specifications Development
The focus of these services is to assist
the client with the increasing demands and complexity of FDA regulations. We have an
excellent history of quality service and a track record of positive results with FDA
compliance requirements and are committed to the principles of quality, integrity,
service, and continual improvement.
W&As Validation Master Plan
process involves all the disciplines necessary for the successful completion of a
validation project. By incorporating the vital aspects of design, engineering, and
validation into your master plan you are provided with an effective tool to guide you,
your contractor, and your validation team through the validation project.
Our Validation Master Plans include a
detailed description, detailed testing requirements and specific acceptance criteria.
Taking a detailed approach to the master plan is an effective and efficient way to assure
a successful validation project. The client and all contractors have a clear understanding
of what is to be validated, how it is to be validated, and together, they have established
the information necessary to facilitate development of validation protocols.
The goal of any validation project is
to achieve a validated facility and process. With this in mind, we recommend that W&A
be a regular participant in design meetings to help accomplish this goal.
W&A personnel have significant
experience in reviewing design packages, including component specifications, schematic and
piping installation drawings, plus construction specifications and procedures. Our
involvement in the design phase, working closely with your engineering firm, provides
early identification of potential validation problems or errors that can lead to potential
delays and/or difficulties in the qualification of a facility.
INSTALLATION AND OPERATIONAL QUALIFICATION TESTING
W&A provides thorough
documentation and evaluation of the installation of your systems and equipment.
W&A provides thorough documentation
and evaluation of the Operational Qualification protocol and will include tests designed
and implemented to challenge systems and equipment in a manner appropriate to their design
and use requirements. In both cases any discrepancies will be documented, the client
notified, and a detailed plan devised to correct the discrepancy and re-test.
Our protocols are designed to be documents
for use in compliance with FDA regulations, and as a potential tool for re-validation
should the system/facility be modified.
W&A supports the life cycle approach
as well as the GAMP guide to implementing and validating computer systems used in the
manufacture of drug products. We develop and implement test protocols designed to test
individual modules, and build up to testing the totally integrated system operation.
W&A testing includes documenting all hardware associated with the system including the
documentation of how the hardware is configured. When possible, W&A participates from
the inception of the system through its implementation validation.
W&A offers performance
qualification services to provide the necessary documented evidence to establish the
reproducability of processes and equipment performance.
Each PQ protocol is designed to include
the appropriate challenge necessary for the design and application of the system or
Final reports are the end-product of
any validation activity. Final reports are the most important aspect of demonstrating the
credibility of the validation firm, and the compliance of the client company.
W&A uses a format for final reports
that provides a clear and concise summary of test results versus acceptance criteria.
During the course of extended validation testing projects, W&A provides periodic
summary/progress reports to the clients personnel. These summary/progress reports
are intended to highlight any testing abnormalities or failures that may occur. These
summary reports allow the client to correct any deviations in a timely manner.
W&A writes Standard Operating
Procedures which describe the proper methods for operation, maintenance, cleaning and
calibration methods for the equipment according to manufacturer's recommendations.
These SOPs will give the client a
firm base from which to begin operations and will enable the clients operators to
use the equipment and expand on the SOPs where needed.
W&A provides review services of
validation packages written and executed by clients or other validation service-related
firms. These reviews are thorough and provide the client with assurance that the
validation and testing performed adequately challenge the operating limits of the
equipment being tested and contain all areas defined in the functional and design
LEGACY SYSTEMS AND
W&A supports validation of systems
and equipment already in place and in use. This validation is similar to that described in
the preceding sections, but is limited to documentation of the systems and equipment on an
"as found" basis. W&A testing includes documenting all hardware and software
associated with the system including how it is configured. Systems and equipment
qualifying for legacy validation include any existing systems or equipment that have not
been validated and for which validation is required.
W&A can provide a validation team
for your construction site that will remain on-site from the beginning of construction
through implementation of the validated facility. We can be most effective if we are
closely involved in the verification of construction/installation activities versus design
requirements. W&A will also coordinate the control of documentation for construction ,
and, if necessary, will create a document control system which centralizes storage and
W&A Project Managers work closely
with customers and contractors to develop a comprehensive validation project plan and
schedule. A Project Manager can facilitate and coordinate the resources necessary to
complete the validation project.