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.
External Links
FDA Guidance:
Quality Systems Approach to
Pharmaceutical CGMP
ICH Guidance:
Q8(R2) - Pharmaceutical Development
Q9 - Quality Risk Management
Q10 - Pharmaceutical Quality System
BioChem QP Consulting Ltd. Registered Office 272 Bath Street, Glasgow G2 4JR
Tel +44 (0)771 897 1245 email enquiries@biochem-qp.com
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
