Consultants to the Pharmaceutical and Healthcare Industries
4 Sharan Place, Forestville  Sydney  NSW  2087  Australia
Enquiries: (61- 2) 9975 6205  Facsimile: (61- 2) 9975 6209  email:eden@zipworld.com.au





GMP CONSULTING . . .



Eden Consulting assists organisations to operate to statutory GMP requirements.
We provide a total service package to enable GMP compliance which satisfies TGA, NRA
FDA, WHO and EU criteria.


Eden offers the following GMP services:


Evaluation of your needs by conducting a Scope of Work Site Assessment.
Advice on the GMP aspects of any building designs or modifications.
GMP Audits and assistance through the official audit processes.
Design and introduction of GMP documentation systems.
GMP staff training.

Organisations unfamiliar with GMP normally require a Scope of Work Site Assessment to be carried out. This enables the consultant and the customer to gain a thorough appreciation of the impact of GMP upon their business prior to the introduction of a GMP system. The system can then be individually tailored to the client's processes and level of consumer risk.

Eden Consulting can provide a balanced GMP perspective on any proposed building designs or modifications. This ensures that the overall design, product flows, equipment, fittings and finishes are GMP compliant. Eden normally works as part of a Project Team from the early design stages of a building proposal.

We maintain a database of GMP documentation. A tailored GMP system is then prepared from this database, specific to your company's requirements. The documentation system comprises SOPs, production and packaging masters, checklists, report proformae, specifications, manuals, registers and logs. Computer validation of electronic systems can be conducted if warranted.

Eden expertly carries out GMP audits and reviews existing plants (and suppliers) in order to identify any areas of non-conformance. Manufacturing errors can then be avoided and statutory GMP compliance can be maintained. Mock audits to TGA, NRA, FDA and EU standards will assist staff to understand the audit process, and can result in corrective action being taken prior to detection by an official government auditor.

Basic GMP
staff training can be conducted to familiarise personnel with the principles of GMP. A lecture series using video and overhead presentations will increase GMP awareness within your organisation. Involvement in an internal audit will assist staff to adopt and foster a GMP culture.
                             
                              NRA VETERINARY MANUFACTURING LICENCES . . .



In Australia, private approved consultants are commissioned by the National Registration Authority (NRA) to carry out official NRA licensing audits of companies involved in the production and packaging of veterinary products.

Rob Warren of Eden Consulting is an NRA Approved GMP Auditor and has authority to conduct official licensing audits on behalf of the NRA. In this capacity Rob can recommend the issue of statutory licences (and NRA accreditation for overseas organisations) for veterinary companies.

In addition, Eden is able to offer consulting services to companies wanting to attain NRA accreditation . . . (please refer to GMP Consulting Services section).
However, a conflict of interests exists where consulting impinges upon the legislative processes. Eden Consulting should be engaged to carry out one, or the other function, but not both within a fixed period of time.





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