#Requirements For 9001 2015 Professional GMP Consultancy
#Requirements For 9001 2015 Code Requirements And

Key Requirements: Top management must manage, not delegate, quality. PrevNext.ISO 9001:2015 Clause 5 Leadership. HelpLine Number Support Centre Timings : 10:30 AM To 05:30 PM (Except Govt Holidays and Sundays ).

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Requirements For 9001 2015 Professional GMP Consultancy

As experts in FDA, PIC/S and EU GMP consulting, we can help you. See industries we serve.PharmOut is a professional GMP consultancy specialising in supporting the medicinal cannabis cultivation industry and new generation medicines pharmaceutical production industry, cosmetics, medical devices, veterinary, pharmaceutical manufacturing industries with offices in Australia, Hong Kong, New Zealand, South Africa, the United Kingdom and United States. Medicinal Cannabis Cultivation & RegulationsAs leading GMP consultants we offer a broad range of services, from GMP compliance, qualification & validation, TGA regulatory, engineering and architectural consulting services to the following industries pharmaceutical, blood & tissue, pesticides, veterinary and medical device manufacturers, as well as related hospital and pharmacy operations.

Requirements For 9001 2015 Code Requirements And

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 or a medicinal cannabis grow house. 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.

Specific to TGA, MedSafe, PIC/S, US FDA or EU. On-site and Public GMP TrainingWe 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. On-site Contracting ServicesIf 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.

Requirements For Iso 9001 2015