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, Polpharma CFO