The Importance of QA in Indian Pharmaceutical Companies

Over the past few years, one of India’s pharma giants has been in the news and not always for the best of reasons. In November 2015, the USFDA issued a Warning Letter to this organisation after inspections at its manufacturing plant revealed glaring violations of data integrity compliance and product quality control. A more recent re-inspection of the company’s pharmaceutical operations in 2017 indicated that not much had changed since the initial issues had been raised. One of the biggest concerns raised by the reports involved the real time scrutiny of analytical operations and procedures. What the auditors discovered was that the manufacturing plant lacked in-depth documentation of production steps and the verification processes required to pass quality control. This non-compliance with the USFDA’s warnings are a huge concern not only for the company but for the entire Indian pharmaceutical industry. Negative press and bad publicity can affect the multimillion dollar industry in significant ways.

However, there is one clear cut route to take to avoid these discrepancies and violations — and that is of a sound and robust Quality Assurance Program across the board in all pharmaceutical operations. Before we get into why Quality Assurance is imperative to the Indian pharma industry, let’s understand what is meant by QA and what is the breadth of its involvement in day to day company processes.

Good Manufacturing Practices or GMP demands an active role by the Quality Assurance (QA) department of any business. When we refer to QA we refer to the step-by-step process of ensuring that all services and goods provided by a company meet the “prescribed standards of quality, efficacy and safety requirements as per their intended use.”

The objectives of a QA team in a pharmaceutical company should therefore include:

• Protecting the public against any risks and hazards associated with the use of their product. This could be caused by accidents during the manufacturing process, inherent defects in research and development and/or instructions for usage or storage of the product.
• Ensuring compliance with industry laws and regulations at every step of the manufacturing and distribution process.
• Protecting the company against penalties, bad publicity, lack of credibility and financial losses.

How then does a “good” pharmaceutical QA department work?

Ideally, a company needs to set up a separate QA team or department before any product is ready to hit the market. From the development stage to the distribution process, QA works in tandem with QC to find and correct defects well in time. If we look at the various stages of the pharmaceutical process we can divide a QA department’s role as follows:

The Development Stage

During the research and development phase of any new drug, the QA team is responsible for checking the quality of external vendors and raw materials, monitoring the testing methods and documentation, ensuring that equipment and operations follow policy procedures, keeping a close check on clinical trials and data recording, along with the formulation of API batches.

The Manufacturing Stage

This is a vast area of responsibility for any QA team and involves the monitoring and approval of documents such as Quality Policy and Objectives, Quality Manual, Validation Master Plan, etc.

The Back Office Stage

These duties are largely unofficial but expected from an involved QA cell of any good business. They may include on the job training, induction training, investigating and marketing customer surveys and market returns, interacting with internal and external auditors, and keeping the authorities involved with any defects and remedial actions taken.

The Distribution Stage

Before any final batch is released it is the duty of the QA department to review and approve all manufacturing records as well as investigate all QC testing data. In case any raw material, packaging or samples do not meet with the regulatory requirements, the QA department will need to initiate an Out of Specification (OOS) investigation. This ensures that future tests are compliant specific and Quality and Technical agreements for other manufacturing sites are met as well.

As can be seen, the QA department plays an imperative role in the pharmaceutical industry. That said, ideally the department should operate independently of the rest of the organisation to optimise its efficacy and maintain an ethical backbone to all processes. With the wholehearted support of top management, all levels of the organisation have to report to any initiative of the QA team. In this way issues such as those raised by the USFDA Indian drug manufacturers can be reduced significantly and proactive efforts can be made towards reducing USFDA Warning Letters as well as audits.

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