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GMP Consultants, Validation, Engineers & Architects

PharmOut is a rapidly growing, pharmaceutical consulting company with local offices in Australia (in Adelaide, Melbourne, Sydney and Brisbane), as well as international offices abroad (in Hong Kong, the UK and New Zealand). We offer GMP compliancequalification & validationTGA regulatoryengineering and architectural consulting services to the pharmaceuticalblood & tissue, pesticides, veterinary and medical device manufacturers, as well as related hospital and pharmacy operations.

As consulting professionals it is our job to stay up to date with current regulations so that we can be sure our customers comply. Have you got time to read them all? Are you sure you are compliant?

What PharmOut offers:

PharmOut holds ISO 9001:2015 certification from LQRA and our Quality Management System is certified to the ISO 9001:2015 standard for the provision of architectural design and consultancy services.

PharmOut’s carefully selected Engineers, Architects and Consultants all have many years of experience spanning the wide reaches of industry from pharmaceuticals and biologics to pharmacy, veterinary and medical device industries.

We have seen and understand all the problems that can occur from the initial facility design all the way to scale up development and manufacturing and we have experience that can help to prevent costly and time consuming mistakes as well as address any problems you might have.

As one of the regions leading pharmaceutical consulting companies, our aim to give you a competitive advantage and our expert GMP consultants, trainers, pharmaceutical engineers and architects are focused on providing practical, cost effective GMP compliant solutions, all of which have a focus on improving your bottom line across the entire life cycle of your products.

PharmOut shares information generously in the form of  forumsblogs, free tools and past presentations.

 

QA and GMP Consulting Expertise

Trevor Schoerie - Engineering, Validation and GMP Consultant

Pharmaceuticals – our pharmaceutical consultants can offer practical knowledge and experience on implementing or enhancing your Pharmaceutical Quality Systems (PQS) to meet GMP code requirements and those based on ICH Q10 / ISO 9001:2015 for Pharmaceuticals.

GMP Audits – we can help with GLP and GMP gap audits / assessments / remediation plans to help you prepare for regulatory audits and inspections from agencies such as the TGA/MHRA/US FDA.

Medical Devices / IVDs – we are well versed in ISO 13485 and have implemented a number of ISO 13485:2003 and ISO13485:2016 Quality Management Systems for medical device manufacturers as well as implementation to meet US FDA 21 CFR Part 820 requirements in the past few years.

Blood and Tissue – we can advise on blood and tissue GMPs – including the country-specific GMPs like those issued by the TGA or Annex 2 from the EU and PIC/S codes of GMP.

Pesticide and Veterinary Drug – we can assist with GMP compliance to the US FDA, EU and the APVMA GMP codes.

Qualification and Validation of Facilities, Utilities, Systems, Equipment and Computerised Systems

Process validation – we offer Pharmaceutical and Medical Device process validation that will comply to PIC/S, EU EMA and US FDA regulations.

Equipment validation – we can validate the equipment you have according to pharmaceutical and international regulatory standards in accordance with current Good Manufacturing Practice.

Cleaning validation  – we can validate cleaning protocols in place for your pharmaceutical and medical device manufacturing facilities.

Computer systems validation – we offer computer systems validation to US FDA 21 CFR Part 11 and TGA, EU and PIC/S PE 009 Annex 11 regulations.

Temperature mapping  – we have the expertise and equipment on hand to perform temperature mapping of your warehouses, cold rooms and other temperature controlled spaces.

Architectural and Engineering Consulting Services

We can help you design, build and operate manufacturing facilities that will fully comply with international Good Manufacturing Practice (GMP) regulations as issued by agencies such as the FDA, MHRA, CFDA and other PIC/S member agencies.

Our pharmaceutical architects and engineers are experts in designing world class health science facilities such as hospitals and aged care units as well as GLP laboratories and GMP-regulated manufacturing sites and cleanrooms. They will ensure that work done adheres to the correct standards and help to avoid costly mistakes.

We also offer a facility design review service and can give an informed independent review of your facility plans to ensure regulatory compliance and efficient workflows within a facility.

Regulatory Affairs – Medical Device / Drug Registration

We can provide advice and answer your questions on the Australian TGA’s medical device and drug registration process as well as prepare dossiers to support drug or device registration with the TGA and conduct mock ISO 13485 audits.

On-site Contracting Services

If you need human resources for a project, we have Pharmaceutical Engineers, GMP Consultants, Validation Consultants, Regulatory Affairs Consultants and Technical Document Writers available at short notice to send to your site at competitive rates.

On-site and Public GMP Training

We offer a wide range of online GMP training courses, these can be purchased and performed as individual courses or bundled courses focused by industry, region and regulatory agency, i.e. specific to TGA, MedSafe, PIC/S, US FDA or EU.

We regularly offer a wide range of public GMP training courses in Adelaide, Auckland, Brisbane, Hong Kong, Melbourne, Perth and Sydney – current our most popular course is the Sydney GMP Training Course. We also frequently fly to any location in the world and deliver GMP training on-site.

 SharePoint eQMS

PharmOut works closely with our sister company, QikSolve, a leading Australian SharePoint consultancy providing a GMP-compliant electronic Quality Management System (eQMS) for regulated companies.

This programme, called Ibiqs, has been based on SharePoint and is a contemporary, efficient and compliant way to manage controlled documentation.

Need to Validate SharePoint, or an eQMS? Click here to find out more.