PharmOut South Africa is a Medicines Control Council (MCC) GMP consultancy and is part of the network of PharmOut companies. In South Africa we offer MCC GMP consulting, pharmaceutical qualification & validation and GMP training to help pharmaceutical, medical device and complementary medicine manufacturers achieve MCC GMP, MHRA GMP, EU GMP, PIC/S GMP, WHO GMP, US FDA and IMDRF compliance.
Our team includes international GMP consultants and experts who have previously held leadership roles within various regulatory bodies.
We focus on the practical application of regulations to achieve compliance in the GMP manufacturing world. Our MCC GMP consultants are familiar with most of the GMP problems that occur in regulated facilities like Pharmaceutical, Medical Device and Biotechnology manufacturers.
We work with multinationals and small start-up companies. Typically, we help Quality Assurance, Qualification & Validation Managers and Engineering Managers within pharmaceutical companies who want to increase profits and export to international markets by having their staff understand and work towards becoming GMP compliant.
Our pharmaceutical qualification & validation consulting services include – facilities, systems & equipment qualification, cleaning validation and computer systems validation, as well as Pharmaceutical and Medical Device Process Validation to MCC, PIC/S, IMDRF, EMA, US FDA and WHO regulations.
We have many experienced Computer Systems Validation consultants within our GMP consultancy who can advise on compliance to US FDA 21 CFR Part 11, EU and PIC/S Annex 11 regulations. More
Your Quality Management System (QMS) is the first place a GMP auditor or inspector will ask to see when they visit your site. The key to good documentation is to “say what you do and do what you say.” Your QMS must document the processes used at your site and you need to ensure your staff are trained and follow your documented procedures. PharmOut also offers an integrated suite of templates for the quick and cost effective creation of a QMS system that complies with international regulations. Simple to use, they will save you hours of development time. More
PharmOut’s team offers practical, hands-on GMP guidance. We only recruit experienced Life Science professionals with a genuine passion for quality. We consult and train on regulatory GMP compliance, product registration, validation and continuous improvement of manufacturing processes. More
PharmOut is lucky to have several consultants who have years of experience as TGA and PIC/S auditors and inspectors. They have in-depth knowledge of the relevant guides and codes used by the regulators to assess GMP compliance, as well as knowing how to interpret the requirements in order to practically apply them. By choosing PharmOut, you will also benefit from their knowledge and experience of what regulators expect and their GMP priorities. 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. PharmOut also offers over 20 different online GMP training courses specifically covering GMP requirements. More