Modern medical and pharmaceutical industry is one of the fastest growing business segments in the world. Last year alone, global medical and pharmaceutical market exceeded USD 260 billion. Yet, many developing countries do not have access to high quality devices and equipments that meet their specific needs. Also, most of the developing countries are still depending on imported devices to meet their vast majority of devices needs.
To add to the troubles, the international standards are being discussed and revived regularly. Hence, there is an increasing need for the pharmaceutical and device manufacturing companies to comply with the global compliance standards and their own national compliance regulations. While this is the progressive side of pharmaceutical industry, the market is equally vulnerable to unscrupulous influences, which can put the patient's life at risk. Therefore, compliance and validation are now regarded as important standards, which ought to be enforced and followed regularly.
Compliance & validation
Compliance is the state of being in accordance with established guidelines, specifications or the process of becoming so. These guidelines are framed by the regulatory authorities to be followed or recommended in order to comply with quality and safety. Like compliance, validation is crucial to determine the quality of the end product.
Validation typically involves actual testing that takes place after the completion of verifications. It is an independent assessment of a project to verify whether the project is in compliance with the appropriate policies, procedures, standards and contractual specifications or not. There are different types of reviews.
They are:
● In-process reviews
● Decision-point/phase-end reviews
● Test readiness reviews
● Test completion reviews
● Post implementation reviews
According to the Clinical laboratory and Diagnostics Center, a large number of people die in India every year due to medical errors occurring in hospitals. Also, the Institute of Medicine (IOM) cites that about 1.3 million Americans are seriously injured each year by adverse events involving medical products. Inadequate design, poor manufacturing quality, improper maintenance and user error contribute to adverse events. To avoid these kinds of mishaps and to produce safe and quality product, international organizations like FDA, ISO, ICH and the EU are exploring the missing link between the current standards and the growing need to match the global compliance regulations. Pavan Gurha, a member of Assocham Expert Committee on Health, says, "The Indian market is characterized by extremes. At one end there are truly world-class certified products and on the other end there are unsafe and uncertified devices. Both should be regulated in an appropriate way to ensure patient safety."
Changing regulations
Today, in the wake of increasing globalization and stringent standards, all major pharmaceutical companies in India are focusing on compliance and validation. In fact, most of the companies are having a special department - Regulatory Department - to monitor the exacting rules and regulations of various countries across the globe. For instance, in US, the Food and Drug Administration (FDA) is now recommending that the pharmaceutical industry submit applications electronically to comply with the internationally agreed standard. The International Conference on Harmonization (ICH) is working with the regulatory authorities of Europe, Japan and US to develop a harmonized pharmaceutical quality system, which is applicable across the life cycle of the product. With each passing day, the regulatory frame work is becoming substantially rigorous and the medical industry is expected to follow the prescribed guidelines.
With the aid of compliance news and management solutions provided by various web sites and other related organizations, India can take a great leap in terms of compliance and validation. The websites serve as the largest resource provider on latest checklists, templates, SOPs, master plans, procedures and application on standards and regulations. Thus, by offering details pertaining to compliance and validation through online, they enable Indian companies to keep abreast of latest developments, helping them abide by the changing guidelines.
There are various web sites serving the industry by offering details through online training. They provide the best opportunity for their members to get the latest news and reviews. The web portals are emerging as the leading solution provider for the medical and pharmaceutical industry. Apart, leading companies in India and abroad are using the enterprise software solutions offered by a variety of companies to achieve compliance with industry regulations. These solutions abide by cGMP and 21 CFR Part 11, Section 302 and 404 of the Sarbanes-Oxley Act, as well as quality initiatives such as ISO 9000 and supplier quality management.
The fast changing world of the pharmaceutical industry needs to keep track of and comply with regulations to meet the quality and safety needs of its consumers. There are many companies in India offering enterprise-level compliance software solutions. It's now in the hands of Indian pharmaceutical companies to adapt and enhance their quality and bring it at par with the global standards.
(The author is a pharmaceutical quality and compliance business analyst with MetricStream)