Quality by design approach: Regulatory Aspect………..!!!


Quality by design approach: Regulatory Aspect……….

In this era of competition quality has been given prime magnitude; failure to meet such quality allied goals produces massive shift of company in share market. In this context pharmaceutical industry is utmost regulated industry as it is governed by authoritative regulatory bodies.

‘‘Quality could be planned and most of quality deficit arises in the way process is planned and developed’’,this thought of well known quality expert Joseph Moses Juran gives foundation to the concept of quality by design (QbD).

USFDA launched a pilot programme in 2005 to permit participating firms a prospect to submit chemistry, manufacturing, and controls (CMC) of NDA information representing application of QbD. Now USFDA is accelerating QbD drive by making warning to generic manufacturers from January 2013. QbD has its perspectives to contribute the drug design, development, and manufacture of high-quality drug products.

 Regulatory aspects to QbD

FDA perspective

In 2005 USFDA asked participating firms to submit chemistry manufacturing control (CMC) information demonstrating application of QbD as part of New Drug Application. QbD involves

thorough understanding of process; a goal or objective is defined before actual start of process. Design space and real time release risk assessment are other parameters for implementation of QbD. International conference on harmonization in its Q8 pharmaceutical development, Q9 quality risk assessment and Q10 pharmaceutical quality system gives stringent requirements regarding quality of product. FDA also states the importance of quality of pharmaceutical products by giving Process Analytical Technology (PAT) which is a Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance (Patricia, 2007).

QbD ultimately helps to implement Q8 and Q9. FDA’s view of QbD is ‘‘QbD is a systematic approach to product and process design and development’’. This concept was accepted by FDA in 2004 and detailed description was given in ‘pharmaceutical cGMPs for 21st century – a risk based approach’.

In nutshell,

  • Product quality and performance can be assured by designing efficient manufacturing processes.
  • Product and process specifications are based on a scientific understanding of how process factors affect product performance.
  • Risk-based regulatory approaches are for scientific understanding and control related process for product quality and performance.
  • Related regulatory policies and measures are modified to accommodate the real time scientific knowledge.
  • Quality assurance is continuous process.

ICH guideline and QbD (ICH guideline Q8, 2012; ICH guideline Q10, 2012; ICH guideline Q9, 2012) The underlying principles of QbD i.e. science- and risk-based product development, risk assessment, lifecycle approach and method design are explained in the quality guidelines of international conference on harmonization i.e. ICH Q8 Pharmaceutical Development, ICHQ9 Quality Risk Management, and ICH Q10 Pharmaceutical Quality System.