TGA, EU Consultants, Validation and GMP service

Surgi Supplies International Pty Ltd is also providing a consultancy in most cities in Australia and other countries, as ISO, TGA consultants, we specialize the operation and design of pharmaceutical, veterinary and medical device manufacturing facilities.

We are providing ISO 9001, 14001 and OHSAS 18001 ISO consultants. Environmental and Quality Solutions specializes in helping companies streamline and maintain their management systems to achieve ISO standards of Quality, Health & Safety & Environmental Management.

Our complete, compliance and validation services can support your next facility, you can be confident that you will get an optimal design that ensures, consideration of lean manufacturing and finally TGA and EU approval. We are providing, ISO 9001 – 2015, ISO 14001 – 2015, ISO 27001 – 2005, ISO 27001 – 2013, ISO 13485 – 2016, ISO 17025, ISO 8000, ISO 22222, ISO Total Quality Management, ISO GMP

GMP Compliance

Pharmaceuticals

A GMP is a system to ensure that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical and medical device production that cannot be eliminated through testing the final product.

 

We can make sure your Quality Management System meets the requirements of TGA and PIC/S and of ICH Q10 / ISO 9001 for pharmaceutical and medical device manufacture. We provide QMS templates and standard documents that we can use to quickly develop policies, procedures, work instructions and forms.

Medical devices / IVDs

Surgi Supplies help industries with an ISO 13485 Quality Management System or support you through meeting US FDA CFR820 and EU requirements.

Validation​

Process validation

We can design a validation protocol or supply validation engineers to ensure compliance with Australian TGA or FDA pharmaceutical or medical device process validation regulations.

Equipment validation

 

Our validation engineers can perform pharmaceutical equipment validation to international regulatory standards and in accordance with current GMPs.

Cleaning validation

 

If you need  cleaning validation for pharmaceutical and medical device manufacturing facilities, our validation engineers can perform a range of tasks, ranging from preparing the high level validation plan through to actually doing the cleaning validation.

Computer Systems validation

 

Computer systems validation to FDA Part 11 and PIC/S Annex 11 regulations is another common request from our customers. We apply the ISPE’s GAMP approach to our computer systems validation.

Temperature mapping

 

Surgi Supplies has the specialized equipment and expertise to undertake temperature mapping of warehouses, refrigerators and cold rooms. This is to ensure compliance with good warehousing practices for time and temperature sensitive pharmaceuticals and other products subject to cold chain management.

Manufacturing continuous improvement

Lean Manufacturing, Six Sigma

If you are trying to reduce costs and waste and streamline your manufacturing processes, all while maintaining regulatory compliance then we can help. Our GMP consultants are experts in managing Continuous Improvement projects, which are often difficult to do in a regulated GMP environment.

GMP project resources

If you have a project that needs experienced GMP professionals or several contractors, Surgi Supplies can provide GMP ConsultantsValidation ConsultantsRegulatory Affairs Consultants, Technical Document Writers.

 

​Surgi Supplies International Pty Ltd

 

+61 3 9466 2803

Unit 3/29 Macquarie Drive, Thomastown, Vic 3074, Australia

EMAIL: jgrindlay@surgisupplies.com.au