Pharmaceutical at Pharmaplaz Ireland

Operational

Pharmaplaz is housed in a fully inegrated purpose built cGMP Facility, operating inder cGMP standard with a manufacturing licence, Investigational medicinal product licence and controller sub The facility is ISO 9001:2000 certified.

The manufacturing area currently consists of:

• 5000 square feet of processing rooms
• Dedicated cleaning room
• Environmental Monitoring
• H.E.P.A. Air filtration
• Sampling & dispensing system
• Warehousing
• Clinical trial packaging line
• Skilled and highly trained operators

Process capabilities

Pharmaplaz will manage projects at any stage of the development cycle from Stage 1 which would include:

• Early stability testing
• Engineering trials
• Formulation development
• Small bench stage projects

to development Stage 2 which includes:

• Process optimisation
• Formulation optimisation
• Process validation
• Scale up
• Transfer of technology
• Process critical parameter identificaton
• Clinical trial manufacture
• Packaging
• Scale up project management

Pharmaplaz have the capacity and capability for commercial product manufacture, which includes full scale processing, manufacture and packaging of commercial product volumes. Our new technology park currently under construction will dramatically increase manufacturing capacity.

Therapeutic areas

• Pain Management - Phase III Clinical Trial
• Cardiovascular - Phase III Clinical Trial
• HIV - PHase II Clinical Trial
• Anti-Inflammatory Agent (NSAIDS) Development - Stage 1 Product
• Immunosuppressant Trial - Bioequivalence Clinical
• Class 11 Antagonists Development - Stage 1 Product

Overall Capabilities

• Package engineering and design
• Material logistics
• Primary packaging
• Secondary packaging
• Labelling and assembly
• Supply chain management
• Stability packaging
• Analytical support
• Team based project management

Quality Control

Pharmaplaz's QC laboratory has experience in assisting partners in the following areas:

• Method Development
• Method Validation
• Method Transfers
• Protocol Development
• ICH Stability Storage & Analysis
• Cleaning Validation
• Finish Product Release Testing
• Raw Material Analysis
• Synthetic Route Development

All methods used are developed and validated in accordance with the appropriate regulatory guidelines, e.g. ICH, cGMP, GLP, FDA, EMEA, USP.

Quality Assurance

Pharmaplaz provides superior outsourcing solutions to the healthcare industry in the areas of process development, manufacturing, packaging, analytical and quality services. We have the knowledge and capability of a large pharmaceutical manufacturer supported by a unique culture of accountability and focus on customer service. This combination of skills and values makes us fast, flexible, and capable to bring products to market with maximum efficiency, quality and consistency. Our quality assurance team incorporates:

• A superior quality and regulatory culture
• Qualified person
• Quality and regulatory experience in FDA environment
• Staff training in all aspects in Operations
• Demonstrated compliance with EMEA and IMB
• ISO 9001:2000 Quality Management Systems accreditation
• Regulatory support and submissions
• Licensed to handle controlled substances
• Drug Master File requirements
• IND and NDA submissions

Clinical Trial Manufacture and Packaging

Pharmaplaz hold and Investigational medicinal product licence from the Irish Medicines Board, which meets the requirements of the European clinical trials directive 2001/20/EEC effective since 01 May 2005.

To better servce your clinical supply needs, our analytical, clinical manufacturing and clinical supply teams work together to provide a quality, seamless continuum for your product's path towards market. Our clinical manufacturing team provides technology transfer, encapsulation, placebo and other services. Our experienced analytical teams also work closely with packaging to provide quality analytical services within your timelines. Services including microbiology testing, release testing and stability testing, compliment and enhance our clinical manufacturing and clinical supply services.