To help quality control heads of Indian pharma companies upgrade audit-readiness, the Indian Drug Manufacturers Association (IDMA) and the UK-based agency NSF International have collaborated to together begin Advanced Program in Pharmaceutical Quality Management (APPQM) for experts in R&D, manufacturing and quality control.
NSF International UK (earlier David Begg Associates) is a global leader in education for the pharma industry. Led by S M Mudda, chairman, Regulatory Affairs Committee, IDMA conceptualized the training program for QA personnel to train and recognize them as qualified people on the lines of courses directed in the UK by NSF, UK.
Technical and QA experts in India are trained in GMP compliance principally through experience and need a formal education in the pharmaceutical quality management of worldwide standards. India is the world’s third-biggest pharmaceutical generics maker with the highest number of FDA and MHRA GMP- approved manufacturing plants outside the US and Europe.
The challenge of present GMP compliance continues to be the main concern and regulatory necessities keep on becoming more stringent and rigorous.
While Sixty-four percent of companies say a shortage of skilled staff is curtailing their growth, as per global counseling firm Deloitte, there is also an urgent need for more effective training, coaching and mentoring to evacuate fear and enable pharma experts, as per Dr. Azaj Hussain, first US FDA Deputy Director of the Office of Pharmaceutical Science.
This program will help quality control heads of Indian pharma organizations improve audit-readiness and implement compliance in areas of good manufacturing practices (GMP), quality management system (QMS), documentation, data integrity and quality assurance The program envelops ICH, WHO and US FDA necessities and best industry practices.
Notwithstanding module-specific content, participants will be provided with a deep understanding of simplification, risk-based decision making and advanced problem-solving skills. Participants will receive practical instruction on the leadership and communication skills required to increase the value of their organizations and to effectively interact with regulatory agencies in the US and EU and other key stakeholders.
NSF has trained regulators from eight regulatory agencies including those in the EU and USA. Respected by the regulatory agency and industry associations, NSF has excellent associations with IDMA, ISPE, PDA organizations and US FDA, WHO and EU regulatory officials. With offices in Delhi, NSF has an astounding understanding of Indian culture and the Indian pharma industry, increased throughout the last 30 years.
The program won’t just help understanding of worldwide regulatory requirements in the wake of resurgence of quality issues over the past few years but will also reduce repeat deviations by 78 percent in only a half year, reduce ‘Human Error’ deviations by 67 percent in a year, help achieve 99 percent ‘Right First Time’ at product release and also help achieve zero regulatory observations following audit.
The program is aimed at reducing the recurrence of customer complaints and quality non-compliances, radical simplification of quality systems to reduce lead times and procedural non-compliances, radical improvement of value frameworks to reduce human error events, designing and implementing a simple procedure for the identification and investigation of out-of-trend results, reducing the frequency of invalid out-of-specification outcomes to accelerate group release and reduce levels of work in progress, improving laboratory productivity by eliminating no-value-added lab laboratory processes and simplification and harmonizing of sops to reduce the burden of documentation and in addition procedural non-compliances.