Whitepaper - How to implement good documentation practices.
As a GMP consultancy, PharmOut offers practical and simple GMP, validation and regulatory affairs solutions for companies seeking to obtain a competitive advantage and compliance to various codes of GMP. Our pharmaceutical consulting team includes international experts and GMP consultants who have previously held leadership roles within regulatory bodies such as PIC/S. Our medical device consultants have extensive knowledge of medical device regulatory requirements, including medical device classifications.
Our approach to current Good Manufacturing Practice (cGMP) is simple - implement simple, concise quality documents that tell your staff what to do and then make sure that they do what has been written - and keep evidence to prove it.
We have GMP consultants to work at your site under your direction on short notice for short or long duration projects. These include: Pharmaceutical Engineers, GMP compliance Consultants, Validation Consultants, Regulatory Affairs Consultants and Technical Document Writers available at short notice on competitive rates.
We implement GLP and GMP Quality Management Systems, perform GMP audits and offer practical recommendations on the implementation of ISO 9001 for Pharmaceutical or ISO 13485 for Medical Device Quality Management Systems, Policies, SOPs and Forms. More
Our GMP consultancy also offers GMP Training for the Pharmaceutical, Medical Device & other Life Science industries, including basic GMP training, GAMP 5 training, ISO 13485 training and Q9 / ISO 14971 quality risk management training courses.More
Our validation consulting services include - equipment validation, cleaning validation and Computer Systems validation as well as Pharmaceutical and Medical Device Process Validation to PIC/S, GHTF, EMA, FDA and TGA regulations.More
We have many experienced Computer Systems Validation consultants within our GMP consultancy who can advise on FDA 21 CFR Part 11 and TGA Annex 11 regulations.
We offer regulatory affairs consultancy services for those wanting to register a medical device or drug with the Australian TGA.More
A 2 day training course covering practical PIC/S requirements for the validation of facilities, services and equipment used in the manufacture of pharmaceuticals.
This course covers the essential principles contained in GAMP 5: A Risk Based Approach to Compliant GxP Computer Systems Validation.