Facility at Pharmaplaz Ireland



The Plaza

Quality Assurance

Pharmaplaz is currently in the process of establishing it's state of the art facility located nearby the Development centre at The Plaza. This modular facility is specifically designed to maximise synergies between various technologies and processes while eliminating co dependency regulatory risks. As part of strategically positioning Pharmaplaz as the complete solution provider to our technology partners, we undertook a strategic initiative to provide a blue print for The Plaza which would facilitate full scale production of products, The 12 acre site will facilitate large scale production of Pharmaceuticals, Nutraceuticals, Sterile, and other Healthcare products. The Technology Park will offer companies an opportunity to locate their manufacturing/development operations in Ireland, where nine of the top ten pharmaceutical companies in the world are already situated

Pharmaplaz provides outsourcing solutions to the nutraceutical industry in the areas of process development, manufacturing, packaging, analytical and quality services. We have the knowledge and capability of a large nutraceutical manufacturer supported by a unique culture of accountability and focus on customer service. This combination of skills and values enables 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
  • Quality and regulatory experience with the US Food & Drug Administration (FDA)
  • Qualified person
  • Staff training in all aspects of Operations
  • Demonstrated compliance with EMEA and IMB
  • Regulatory support and submissions
  • ISO 9001: 2000 Quality Management Systems accreditation

Operational

Analytical

Our manufacturing cGMP facility consists of a rapid set up, therefore a greater high quality output. 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

The New Plaza facility currently under construction will increase the manufacturing capability by adding an additional 150,000 square feet of processing areas.

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The Analytical Laboratory contains state of the art analytical equipment all in compliance with CFR 21 Part 11. The laboratory has a proven track record 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 and USP.

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Therapeutic areas

Quality Control

Pharmaplaz has experience in progressing a wide range of projects for our partners in the Therapeutic areas of:

  • Osteoarthritis
  • Gastro Intestinal Tract
  • Cholesterol control
  • Cardiovascular
  • Diet Balance
    • Diet Supplement
    • Re-hydration
  • Energy from diabetic friendly non sugar sources

Pharmaplaz's laboratory personnel have experience in the following areas of nutraceutical quality analysis:

  • Raw Material Analysis
  • Method Development
  • Protocol Development
  • Method Validation
  • Method Transfers
  • ICH Stability Storage (product shelf life/expiration) & Analysis
  • Finish Product Release Testing