QUALITY CHALLENGES Rohan Patel Head of Quality Assurance Cosmos Limited

Few of many Quality challenges Increasing International Regulatory Requirement CAPA Competition among local manufacturers Data Integrity WHO Pre-qualification

The Race for Quality has no finishing Line……… Increasing International Regulatory Requirement The Race for Quality has no finishing Line……… 1959 1978 1984 2004 2007 2008 2015 2017 Founder moved to Kenya to work as pharmacist Wholesale business acquisition Manufacturing start of essential drugs Construction of first site with expanded capacities GSK and BI voluntary license for ARV manufacturing USAID certification European PICS certification Construction of GMP tablet block Business expansion into African markets Market leadership in Kenya COSMOS Race towards achieving Quality Success. ----- -----

CAPA = COST = QUALITY IMPROVEMENT CORRECTIVE AND Preventive Action CAPA is much more than just “corrective actions” and “preventive actions”. Any opportunity to improve quality in any organization is a CAPA. Most Pharmaceutical QUALTIY SYSTEM triggers to CAPA. Corrective Action = Easy to handle (To immediate correct the situation). Preventive Action = Difficult to handle (To introduce new measures or To monitor the process for introducing new measures to prevent reoccurrence). CAPA = COST = QUALITY IMPROVEMENT

Competition among local manufacturers QUALITY Manufacturer’s against NON-QUALITY Manufacturer’s QUALITY Manufacturer’s try to upgrade their manufacturing plants by investing and implementing QMS while on the other side NON-QUALITY Manufacturer’s continue its manufacturing without QMS system. No motivation to QUALITY Manufacturer’s from local regulatory agency. COST of Production for QUALITY Manufacturer’s

DATA INTEGRITY Retaining Competent / Trained technical staff. Effective training to new entrants. Cultural training, mind-set corrections and moulding of newly recruited staff from other organisations into Quality Culture of company. Adherence to procedures and policies in place. Awareness and correct interpretation of regulations and cGMP requirements. 21 CFR PART 11 compliance Software and setting of different levels of user rights.

WHO Pre-qualification Cosmos is working towards WHO-PQ since 2012 and have successfully cleared safety and efficacy part of the dossier and we are now only 1 step behind in achieving the same i.e. Quality Part (Inspection). Since 2012, many challenges came across our way and we solved them by working as a team. Few challenges are still under progress and we are thinking before we implement what regulatory is asking, we should give a very deep thought and understand the regulatory requirements in order to avoid any future discrepancy. One of the challenge is Starting Material Coding: Does the material requires a specific code related to its manufacturer name, site of manufacturing and its specification? Or what if material code is related to only material and QA checks at different stages (i.e during procurement, receiving and sampling). Intention in either case is the same i.e. to get correct material form approved vendor. Hope, we will get some clarification from our trainers during this forum.

THANK You