Polpharma, Poland
Reference regarding David Forrest and Carl
Turner from Compliance Control Ltd.
Polpharma is focused on production of Active Pharmaceutical
Ingredients (API's) and development of branded generic
pharmaceutical products. Polpharma is a leading Polish healthcare
company. The strong branded products are franchised in
cardiovascular, gastrointestinal, CNS/pain and consumer medicines.
Polpharma is the biggest APls producer in Poland. Its synthesis
plant consists of: salicylic acid and derivatives, sulphonamides,
psychotropics and custom syntheses. Polpharma is a qualified
supplier of APls for many worldwide pharmaceutical companies.
Everything the company does is based on its experience in the
industry since 1935. Particular care at every stage of production
guarantees the highest quality. The modem technologies in use at
Polpharma's facilities target compliance with GAMP4 and GLP
requirements, and its pharmaceutical production is approved by
audits of the US FDA. Having achieved a strong position in Poland,
Europe and North America. Polpharma has a strong platform for future
development.
Polpharma required a system to manage their global
business and be adaptable enough to be able to add acquired
pharmaceutical businesses to their organization when necessary, the
system had la be able to operate in multiple languages and multiple
currencies as well as giving the senior management the ability to be
able to view and report globally, the system also needed to be
easily upgraded with new functionality when required. The chosen
solution had also to be compliant with all the current regulatory
requirements for the Pharmaceutical industry
In order to meet the
business requirements, Polpharma have been implementing Oracle E·
Business Applications in a phased approach since the end of 2002,
with Financials and Logistics modules going live in August 2003.
The
modules included in the implementation are:- ·
Oracle
Financials
Oracle Order Management
Oracle
Purchasing
Oracle Inventory
Warehouse Management
System
Oracle Process Manufacture Suite
Advance
Planning & Scheduling and Demand Planner
Compliance Control have
been instrumental in the success of Oracle in Polpharma, ensuring a
GAMP compliant and validated system.
When we started our Oracle Applications project
tor Polpharma in Poland, Compliance Control were recommended to us
by Oracle. Since Compliance Control started with us, they have
enabled us to understand how we can ensure that our Oracle
Implementation can be compliant and validated. David, CarI and his team work seamlessly with Polpharma and Oracle
implementation team in helping to ensure that as the project
progresses all the GAMP 4 requirements are met
This started with the
creation, review and approval of a Validation Master Plan, that
acted as the driving force behind the project and the deliverables.
The fact that they are involved in the GAMP Forum and on many of the
GAMP Special Interest Groups, ensures that we are kept up-to-date
and informed of global issues in the industry so that we can ensure
that our system complies with the latest understanding.
Carl and
his team worked in parallel with oracle and percipient
implementation consultants. to ensure that all the key GMP issues,
documents and deliverables were in place when needed, Assessments
and reviews of the GMP critical functions were carried out, and also
complete documentation to ensure that all the 21 CFR Part 11
functions were implemented correctly.
Carl acted on behalf of our
Quality Assurance department and reported directly to the steering
committee. In this way we knew immediately if there were any Quality
Assurance issues.
Carl and his team ensured that all the
documentation was controlled and up-to-date and in particular
ensured that once a deliverable was approved and frozen, that change
control was used thereafter.
Two key areas were in the
Design/Specification stage, and the Testing phase. It was important
that all documentation was reviewed and in particular that the
Functional/Configuration specifications were sufficiently detailed
in the GMP areas to ensure that the test specifications and
protocols required for the IQ,OQ and PQ were also detailed enough.
Compliance Control also ensured that all the testing process was
carried out in an organized and professional manner so that all the
test results were collated, reviewed, and signed off to ensure that
the final validation report was approved.
I believe that not only did
Compliance Control ensure that the project was compliant and
validated but that it also ensured that the project was on time, by
following the strict deliverables and time line in the Validation
Plan.
The result was a Compliant and Validated system that has now
been inspected by regulatory authorities including the FDA which
passed with no major issues.
I would not attempt to carry out a
similar complex system implementation in such a GxP critical
situation without the help of such industry experts. Not only will
Compliance Control ensure your project is Compliant and Validated,
but that they will do it in a cost effective way,
A further
by-product of their help was the 'knowledge transfer' by providing
formal training courses to our internal staff, and 'on the job'
training so that we are now in a position to support and maintain
the validated status of the system using our internal resources.
I
can certainly recommend Compliance Control as experts in this field
and they will add value and deliver on your project
Thank you
Wlodek
Gryglewicz, PhD, MBA
Polpharma CFO
|