Express Pharma

Stressing on quality assurance through LC-MS bioanalytical tools

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SCIEX with Express Pharma recently conducted a workshop with a vision to stress upon the importance of identification and qualitification of impurities in ensuring quality and safety practices

Raelene KambliGangtok

Identification and quantification of impurities in drug compounds is an important function when it comes to pharmaceutical process development for quality and safety. According to experts, it is extremely paramount to identify unwanted chemicals that remain with the active pharmaceutical ingredients (APIs), or develop during stability testing, or during formulation or upon aging of both APIs and formulated APIs in medicines. The presence of these unwanted chemicals even in small amounts can influence the efficacy and safety of pharma products. Keeping this in mind, Indian regulatory agencies have therefore, put in place guidelines which mandate the identification and profiling of impurities in APIs and formulated drug products.

Taking this vision forward and to stress upon the importance of identification and qualitification of impurities in ensuring quality and safety practices, Express Pharma and SCIEX, a global leader in life science analytical technology recently conducted a workshop on ‘LC-MS as an imperative bioanalytical tool in Pharma and Personal care segment’ in Gangtok, Sikkim. The workshop was attended by around 40 plant heads, quality control officers, quality assurance managers, project heads and scientific officers from various pharma companies.

Why Gangtok?

As reported earlier by Express Pharma, Sikkim is likely to emerge as a major pharma hub in the North Eastern region by 2018. The state has already attracted an investment of over $400 million (Rs 2000 crores). As per the Commerce and Industries Department, Government of Sikkim, presently, Sikkim is home to as many as 22 pharma companies, out of which 16 are big firms, one is medium and five are small scale firms. These include the who’s who of the Indian pharma sector such as Cipla, Sun, Zydus Cadila, Alembic Pharma, IPCA, Alkem, Intas, Torrent, Unichem and Micro Labs  from 22 major pharma companies in the last three years.

With several pharma companies setting -up manufacturing plant in this pristine hilly state was an obvious choice to conduct the workshop and emphaisis on quality workflows.

The workshop

The session began with a brief introduction to the topic of the workshop by the Express Pharma correspondent followed by a presentation on SCIEX India and its role within the pharma sector. Gurkirat Singh, Marketing Manager, SCIEX India explained how SCIEX is committed to quality solutions and how their solutions enables scientists and laboratory analysts to find answers to the complex analytical challenges they face. He further gave an overview of their global business as well as their market share in India.

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From thereon, Dr Anoop Kumar, Application Support Manager, Pharma/ Non Pharma Support SCIEX, India took over the proceedings for the afternoon.  He began the workshop by firstly accentuating on the development of impurity profiling methods using modern analytical technique and the importance of  liquid chromatography-mass spectrometry (LC-MS) method for determination of potential genotoxic impurities. Then, he explained on how this method can be useful in the separation of optically active drugs. He said that LC-MS helps in improving the efficiency of drug discovery due to its excellent sensitivity and specificity. The technique can be combined with stable isotope dilution for precise and reproducible assays.

He elaborated on the effectiveness of SCIEX solution to provide a novel workflow for screening and identification of a multitude of targeted analytes.  Kumar said, “To ensure patient safety regulatory agencies have put in place guidelines which mandate the identification and profiling of impurities in APIs and formulated drug products and sets thresholds at which these impurities must be reported. A fast, high throughput, robust, and reproducible analytical technology and method is critical for increased confidence in impurity identification, detection, and quantification in pharma research. In every step of the impurity profiling workflow from data acquisition, identification and characterisation of impurities, to batch-to-batch comparison, and quantification of impurities, the SCIEX solution assists scientists.”

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Moving forward,  he also provided information on SCIEX’s QTRAP Systems that provide a novel workflow for screening and identification of a multitude of targeted analytes.

Dr Kumar’s presentation and scientific knowledge kept the audiences engaged. There were many valid questions raised and many doubts cleared.

Dr Kumar also provided many case examples that the audiences associated with as they pointed out that in their daily practice they come across such challenges and that this workshop helped them get the insights they require to overcome these challenges.

The evening ended with cocktail and snacks wherein the audience networked with each other as well as discussed issues related to quality assurance.

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