A Glimpse Inside Pharmaceutical Quality !!
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A Glimpse Inside Pharmaceutical Quality !!

EXIM Professional

Over the past decade, the Indian pharmaceutical market has grown by nearly 17 percent and continues to experience immense growth. However, in order to fully realize the nation’s potential as an important player in the global pharmaceutical industry, India’s regulatory infrastructure must keep pace to ensure that global quality and safety standards are met. Quality issues are an ongoing challenge for the Indian pharmaceutical industry.

We all do not wants the resources to be wasted on incompetent development and weak processing or manufacturing systems that could actually become a road block to the success of any products. Companies want greater competition, and some more options for any product and more affordable alternatives to comparable products. Market researchers agree that achieving quality requires regulators and industry similar to champion and advance a quality culture throughout the product life-cycle, by effectively employing the use of data and science and requiring greater transparency. Indian regulators and industry both recognize that a quality culture is imperative if India wants to increase productivity, reduce compliance risk, lower rework, and minimize supply interruptions that result in loss of revenue and increased risks to public health.

This greater emphasis on quality will also allow India to participate more in existing global venues such as the International Council for Harmonization (ICH) , it has a consistent guidelines for the manufacturers to produce a new product – which will enable stronger collaboration and synergies among regulators. Quality is good for economic development, the market, and most importantly, patients and consumers everywhere. The high price of drugs, poverty, poor supply chain, ineffective regulations and enforcement a the major factors for the spread of counterfeit drugs, .

As such like Quality there is another major risk factor is Data integrity!! Which can be define more as  critical to follow for the maintenance of regulatory compliance, First one need to  understand what FDA requires in terms of data integrity,  FDA uses the acronym ALCOA to define its expectations of electronic data. ( source of ALCOA – {Article on Data Integrity  by Pharmaceutical Manufacturing})**

The Data must be Attributable – which means to be more  qualified and definite.

Legible  - data should be more understandable.

Contemporaneous –need for synchronization

Original  & Accurate – the basic fundamentals to be followed for preparing any data.

In addition, this is the definition of data integrity that FDA uses for internal training: “Data are of high quality if they are fit for their intended uses in operations, decision-making and planning . . . as data volume increases, the question of internal consistency within data becomes paramount….”

Research say the company produces products  regularly  is evidence of a larger problem in India. Indeed, economists often struggle to understand the market: demand (in the form of the diagnosis and prescription by Doctors) is set by the supplier. The patient (or consumer) is almost entirely subject to these decisions and has little recourse to seek an alternative.

As such, pharmaceutical sales agents have diverse attractions to offer a cork to a local doctor Unfortunately, this is a structural problem within the industry. Corruption will persist until the pharmaceutical companies can establish airtight compliance processes to address this. The cost of these processes is likely to be astronomic, given that they affect so many complex relationships.