15th APIC Conference in 2012

The Importance of Quality and Risk-based Strategies: Highlights of the 15th APIC European Conference on Active Substances

In the light of a continuous increase of the amount of sub-standard or falsified active substances in the global network of API manufacturing and distribution the importance of a quality culture and the unique role of the QP with respect to API quality oversight are key aspects. These and other relevant topics with respect to quality of APIs were discussed on the 15th European APIC Conference in Budapest. In the opening presentation Moheb Nasr from GSK discussed the development and implementation of Risk-based control strategies of APIs on the basis of relevant ICH Guidelines. ICH Q6A e.g. provides flexible regulatory approaches but requires specifications to be chosen in order to confirm quality and to ensure the safety and efficacy. Control Strategy is closely linked with enhanced product and process understanding and is defined in three ICH Guidelines, ICH Q8, Q10 and Q11 in the same way, namely as a planned set of controls that assures process performance and product quality. One of the key issues of a successful control strategy outlined in ICH Q11 is the selection of Starting Materials. Ms Nasr emphasised the importance of indicating sufficient details of the manufacturing process in the regulatory submission to facilitate the assessor's understanding of the proposed control strategy.

Protecting product quality and patient safety can only be achieved in an environment in which each and every person understands their responsibility. APIC president Mr Anthony Storey took this as a key statement in his presentation about quality culture. ICH Q10 clearly indicates that leadership creates quality culture and is responsible for sustaining it; in other words: Quality Culture has to come from the top. As an effective Quality System example Mr Storey discussed robust deviation investigations and managements role in this case. Quality Culture can be measured and should be measured and as a consequence sufficient resources have to be provided. Ms Storey clearly stated that also suppliers and contractors should be assessed for their Quality Culture and also inspectors or auditors should watch narrowly the Quality Culture of the site being inspected/audited.

"ICH Q3D - Elemental Impurities" is one of the ICH Quality Guidelines currently under way to reach step 2 of the ICH harmonisation process. Ms Melissa Figgins, member of the Q3D EWG explained the current status of the guideline process regarding ICH Q3D. After approval of the concept plan and the associated business plan on December 2011 constituents from participating trade organisations and regulatory authorities asked to comment. So a second review took place following the November 2012 ICH meeting. Industry and Regulators from US, Europe, Japan and beyond work side by side to establish scientific consensus. The publication of the consensus document is awaited to be presented for public comment after the EWG meeting in June 2013. Ms Figgins discussed the recent approach enhancements of the guideline regarding the classification system of metal impurities based on potential impact to patient safety and the reduction of scope regarding metals with low safety concerns.

As most of the APIs or Starting Materials used for the manufacture of drug products are produced in China and exported to the European Union it is important to know about the regulatory framework of GMP in this country. Ms Qing Shen from the GMP Department, Certification & Evaluation Center of the Shanghai Municipal FDA explained the Chinese Drug Regulatory System. This framework has been revised twice, 1998 and 2010. As a consequence of the last revision the general provisions of the Chinese GMP rules have been amended with regard to Honesty, Higher qualifications of personnel, pharmaceutical quality system, complete and detailed documentation and integration to other regulations. Moreover ICH Q7 was referred and adopted, the control requirements of APIs manufactured by cell culture/fermentation were added and the requirements of recovery, reprocessing and rework were detailed. China aims to enter PIC/S. Ms Qing Shen outlined the steps on this way which have already been completed: The vaccine surveillance system of SFDA passed the WHO evaluation in 2010  and in 2012 CCD of SFDA passed the ISO 9000 certification by China Quality Mark Certification Group.

Once more the conference offered a wealth of new information to the delegates. The high quality of the lectures given by key representatives from both industry and authorities combined with the willingness to discuss matters in all openness, resulted in this event again contributing much to a further increase in mutual understanding between the API industry and the supervisory and registration authorities.

Many of the new developments reported at this conference are snapshots, so we all looking forward to what the 16th APIC Conference, to be held in Madrid from 6 to 8 November 2013, will bring.