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Architectural and Engineering Consulting ServicesWe 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 growers, 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. Qualification and Validation of Facilities, Utilities, Systems, Equipment and Computerised SystemsProcess 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. QA, GACP and GMP Consulting ExpertisePharmaceuticals – 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 GCP, 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 experienced 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. What PharmOut OffersPharmOut 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, engineering and consultancy services.PharmOut’s carefully selected professional 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 most 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 a leading pharmaceutical consulting company, 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 whitepapers, blogs, free tools and past presentations. As experts in FDA, PIC/S and EU GMP consulting, we can help you.
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