Changing Regulatory Expectations for your QMS Over the last decade, the fundamental importance of an effective GMP Quality Management System (QMS) has been re-emphasised by the major regulatory authorities. There have been 2 updates to the ‘Quality Management’ section of the EU GMP Guide since 2005, with further additions planned. In the US, the ‘Pharmaceutical CGMPs for the 21st Century Initiative’ brought us FDA’s ‘Quality Systems Approach’. The International Conference on Harmonisation (ICH) finalised its Q10 guideline on Pharmaceutical Quality Systems in 2008, which along with Q8 and Q9, will set the benchmark for pharmaceutical QMS expectations for years to come. Many of these changes merely formalised existing good industry practices, but there is now an onus to demonstrate that process knowledge, risk management, continuous improvement, and management involvement are all hard-wired into your QMS. Your management of deviations, changes, and CAPA is being subjected to ever closer regulatory scrutiny (see ‘common inspection deficiencies’ in the links panel), as are your processes to ensure that resources are matched appropriately to patient and business risk. What BioChem QP Consulting can do for your QMS Having been ‘at the coal face’ during the implementation of these QMS changes, BioChem QP Consulting can help start-ups / smaller-scale organisations design and implement a GMP compliant QMS that meets your current requirements and will grow with your business. Maximum use is made of visual tools such as mind-maps and flowcharts to provide concise, intiutive documentation (see example mind-map summary of ICH Q10). For established organisations, BioChem QP Consulting can perform an in-depth audit of your QMS against current expectations - fulfilling the requirement to include an independent assessment of the QMS as part of your existing self- inspection program, and actively identifying ways in which you can simplify, streamline, and improve the effectiveness of your QMS.
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BioChem QP Consulting Ltd. Registered Office 272 Bath Street, Glasgow G2 4JR Tel +44 (0)771 897 1245   email
Quality Management Design & maintenance for your Quality Management System
MHRA Deficiency Reports: The link below to MHRA presentations, summarising deficiency data from 2008-2012, shows that core QMS activities such as investigation of ‘anomalies’, management of change and CAPA, still cause industry significant problems: Common Inspection Deficiencies
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