Indian pharma industry is expected to face challenges during the implementation of the International Conference on Harmonization (ICH) new guideline on Q11 focusing on the development and manufacture of drug substances.  While the guideline was released to update the pharma industry to attune to the latest norms, there are apprehensions of acceptance and understanding of the importance of its interpretation. While there have been four guidelines Q7, 8 9 & 10, the latest Q11 released in November 2012 is seen as an  improved approach on drug product development, according to Dr Rajiv Desai, president – Quality, Dishman Pharmaceuticals and Chemicals, Ahmedabad.

There are challenges in implementation of Q11. But the ICH is looking to ensure adherence of Q11 guideline which is a different approach to process development, with a clearly defined concept of critical quality attributes, with methodical steps for submission of process development information in CTD format, stated Dr. Desai, while addressing on the topic ‘Encouraging Enforcement of Regulations’ at the DIA regulatory conclave held a few weeks ago.

Its links material attributes to process parameters, and a control strategy for the development and manufacture of drug substances covering chemical and biological entities with large and small molecule, all rolled together in one guidance.  This is expected to be future proof in drug manufacture, he added.

The new guideline from ICH broadly includes the concepts of Q8, Q9 and Q10 which are  applicable for drug substance as well as drug product.  However, manufacturing process for drug substance is different than a drug product under the Q11 norms.

The ICH brings together the regulatory authorities of EU, US and Japan scientific and technical aspects of pharmaceutical product registration. It provides a comprehensive update about the international regulatory guidelines and went to release the Q7 norms in November 2000 on good manufacturing practice (GMP) guide for active pharmaceutical ingredients (APIs). In 2005, it released both Q8 focusing on pharmaceutical development and Q 9 dealing with quality risk management (QRM). In June 2008, the Q 10 was issued which are norms on pharmaceutical quality system (PQS). Now with ICH Q11, the expert committee  had a biggest challenge  of making sure they  could  clarify some of the differences   from the earlier quality norms.  

 While the   aim of ICH Q8 was to reduce post approval submissions and reduce real time quality checks, the ICH Q9 highlighted risk management principles.  In pharmaceuticals, the stakeholders are patients, medical practitioners, Industry and Government. Therefore it provided the aspects for the  protection of patients by managing risk to quality , said Dr. Desai.

In the case of ICH Q10 Pharmaceutical Quality System, it complimented with  ICH Q7, Q8 and Q9 to demonstrate industry and regulatory authorities support to enhance quality and availability of medicines around the world for public health. It also encourages innovation and continual improvement throughout product lifecycle besides strengthened the  link between process development and manufacturing.

Now the ICH Q 11 elaborates Q 8 to highlight  the capability to consistently produce drug substance with  the intended quality. The Indian pharma would face issues to understand the Q11 on the kind of advantages it would bring to the manufacturer or whether it would radically change the way things are currently done, said Dr. Desai and concluded by stating that it needed to be implemented because it was for the benefit of the industry.