Frequently Asked Questions
- Q. 1. What is Quality Management System?+
- Q. 2. What are the major issues of concern to develop an effective QMS?+
- Q. 3. Where a QMS can be implemented?+
- Q. 4. What is ISO certification?+
- Q. 5. ISO certification is provided by which regulatory body/agency?+
- Q. 6. What are third party audits?+
- Q. 7. What are mock audits/inspections and what are their benefits?+
- Q. 8. What is Business Plan Development (BPD) and how it can be helpful?+
- Q. 9. What is Portfolio Management System (PMS) and what is its significance?+
- Q. 10. What is commercialization of research and how it works?+
- Q. 11. What are the services provided under “Pharmaceutical Product Development”(PPD)?+
A.Quality Management System (QMS) is the system designed & developed to overcome any unwanted outcome for the efforts made to provide any product or service of intended quality attributes. Simply in the era of customer satisfaction it can also be stated as the “system providing customer satisfaction” for the given product or service.
A.As QMS is designed for customer satisfaction in terms of quality of product or service, so it takes care of almost all the matters of concern related to the quality i.e. it covers Men, Material, Method and machine.
A.QMS can’t be confined to any boundaries pertaining to the size of organization and type of organization; simply it is helpful for almost all type of organizations, whether big/ small or providing either product or service. But the QMS has to be tailored according to the need of the organization and their area of functioning to yield worthful results.
A.ISO only frames different type of standards for various segments and the best reason to implement these standards is improvisation in the efficiency and effectiveness of the operations carried out by the company. However, ISO is not directly or indirectly involved in the certification for any of the standard(s) developed by the same. Certification is generally performed by external certification bodies (which are largely private) and this certification is not mandatory by the ISO, for implementation of ISO standards. But it has been made mandatory by number of regulatory agencies across the globe. For more details, please visit the page: http://www.iso.org/iso/home/standards/certification.htm So, ISO certification can be stated as if the “quality marker”; it is basically the standard for qualification of any product/service to the pre-defined quality attributes, either laid by any regulatory agency or defined in-house, for trust-worthy outcome of the product/service provided. ISO covers a wide range of industries and other organizations in its spectrum; even some regulatory agencies have made ISO certification as one of the mandatory requisite.
A.Certification is generally performed by external certification bodies (which are largely private) and this certification is not mandatory by the ISO, for implementation of ISO standards. But it has been made mandatory by number of regulatory agencies across the globe. ISO certification is provided by number of agencies through-out the globe, through certified Auditors.
A.Third party audits are the audits carried out by any of the external agency, which is not directly or indirectly concerned with the business and/or organization of the auditee; thus these audits are known as the non-biased audits, as there is no any chance for any type of internal or external influence on the audit reports.
A.Whenever there is any requirement of system/facility audit for regulatory compliance for the sake of any approval and/or certification, then it is always beneficial to have mock inspections/audits by any third party to assure high degree of satisfaction for the prevailing system/facilities. These mock inspections helps in highlighting critical issues prior to the such inspections/audits carried-out by the regulatory agencies and thus helps in saving time and money both.
A.Business Plan Development (BPD) is the system of developing business strategies & plans for smooth execution of the business with optimal utilization of the available resources. For any new business venture there are certain issues in the initial stages which can be considered as critical issue like availability & utilization of finance and human resource etc. In BPD the experts look into the business details like its type, area of applicability, market demand etc., and accordingly the strategies are framed for the start and expansion of the business. So BPD can be stated as the skillful expression of any business for its successful incorporation and expansion.
A.Portfolio Management System (PMS) can be defined as if the plans for strategic investment, depending upon the prevailing market opportunities and optimal use of finance (financial management). This system helps in getting better business outputs via designing expert strategies and line of action for market investments.
A.Commercialization of research simply means the “commercialization of research carried-out at lower levels”, i.e. bringing and converting the innovative ideas in to worthful products or services; meant to be utilized for commercially. Generally it can be taken as if the development of half done or incomplete research innovations at commercial level; this will allow researchers/innovators working at institutional levels to come forward with their commercially viable creations and get their creations protected under IPR protection or extend their work in industrial collaboration.
A.PPD covers almost all aspects of Pharmaceutical Product Development that majorly includes troubleshooting pertaining to Product Development, Package & Package Insert designing etc. It covers all type of Pharmaceutical Products i.e., Allopathic Products, Herbal Products, Ayurvedic Products, Nutraceuticals and many more.