Harmonization of standards, product specifications and regulations is one of the major challenges for an Indian manufacturer and exporter. Challenges in global quality management includes suspect counterfeit product, contamination, defective components, poor packaging or product mix-up, questionable stability, medical device malfunctions and labelling concerns. These were the thoughts shared at the IDMA- APA 17th Pharmaceutical Analysts' Convention held in Mumbai from 26 to 27 September 2014 under the theme "Challenges in Global Quality Management."
Speaking on the sidelines of the seminar, chief guest of the occasion Dr Ronald Piervincenzi, CEO, United States Pharmacopoeia (USP), said, "USP is engaged in multiple harmonization efforts, including the Pharmacopoeial Discussion Group (PDG) and a prospective harmonization pilot with European Pharmacopoeia. Initial learnings have revealed a number of harmonization related challenges including protracted execution timelines and complex processes for collaboration. USP, however, is championing the exploration of new approaches to improve harmonization including moving from regional to global co-operation, working to harmonize development approaches and increasing joint standards collaboration."
He concluded that harmonization can help strengthen individual pharmacopoeias with stronger monographs with a global set of experts setting standards which will lead to minimising duplication of testing requirements, reducing inconsistencies.
With the growth of the industry and the ever evolving skills in science and technology , there are monumental changes in the discipline of pharmaceutical analysis today. The focus has shifted from purity to impurities and safety of the molecules. Explains J L Sipahimalani, chairman, Technical and Quality Management Sub -Commitee, Indian Drug Manufacturers' Association (IDMA),"Keeping with current scenario in the pharma industry, all the professionals in the quality control department are required to comply with the global regulatory requirements. Data integrity, quality culture, root cause analysis and training evaluation are the relevant subjects to be continually addressed."
Echoing similar views, S V Veerramani, president, IDMA said, "Purity standards are a given and easily achieved by an average manufacturer, but, today's analyst has to focus more on impurities. The increasing awareness of patient safety and availability of various toxicological information on these impurities which has tremendous impact on human health makes the job of an analyst far more challenging. An analyst is required to understand increasing regulatory requirements and organizational good practices with regard to specifications and testing."
"Challenges in global quality management can be met through product quality management challenges during manufacturing, shipping and storage. Assurance to patients and regulators may be offered through appropriate product design (Quality by Design), Identifying quality target product profile (QTPP) and critical process variables, process validation, process analytical technology (PAT), using quality risk management and principles throughout product life cycle," explained Dr Nandkumar Chodankar, CEO, A Solution Pharmaceutical Pvt Ltd.
An area of particular importance is educating employees about the audit. The employee knowledge, backed by an effective internal system, will enable a company to demonstrate GMP compliance. Added Dr Kavita Mehrotra, global head, Global Strategic Alliance, Underwriters Lab, EduNeering, "The inspector's observation can help the company to identify and address any actual or potential issue related to quality, compliance and safety."
Talking about the increasing global requirement for evolving regulatory compliance in regulated and unregulated markets, Dr K Bangarurajan, deputy drugs controller of India stressed on the need for uniformity of GMP inspections for supplying quality drugs globally.
AG Raghu, technical director, Gland Chemicals Pvt Ltd was conferred the Outstanding Pharma Analyst Award- 2014 and Dr N Satheesh Kumar, asst professor, department of pharmaceutical analysis, National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad was conferred with Young Pharma Analyst Award- 2014 during the event.