Interview with Shaligram Rane, Vice President & Site Head Quality, Lupin Pharmaceuticals

Update : 23rd May, 2023

Lupin Pharmaceuticals Vice President Shaligram Rane talks to Cold Chain Platform about the challenges of supply chain quality. The interview was carried out in partnership with LogiPharma Asia Summit 2023 (June 20 - 21, 2023 Equarius Hotel, Singapore).

1. What do you see are the biggest challenges for ensuring quality in the APAC region?

Quality is well maintained against defined norms and standards in the pharma industry. At the manufacturing site, quality is well maintained. However, when pharmaceutical product reaches the pharmacist or patient, it is often observed that quality is not as expected, and sometimes major market complaints are registered. The biggest challenge is maintaining product quality during transit in the APAC region, as temperatures vary from region to region. Also, it is observed that the product handling team is usually unaware of the storage and transit conditions.

2. What are the most common quality tools for supply chain excellence, and what impact do they have?

Collaboration with partners and understanding manufacturers' requirements to maintain the quality standard during transit, including storage, is essential. I think an online monitoring system, through a well-developed, robust digitalization system, will ensure and assure product delivery quality. Such a system can provide confidence to the partner and help the relationship between the supply chain provider and manufacturer. Appropriate training from the manufacturer about product handling is also highly recommended. The key to success lies in focusing on design, production, delivery, support, and supplier-customer relationships. Evaluating best practices to maintain relationships between total quality management factors and the transition to supply chain quality management can positively impact deliverables.

3. How do you educate non-quality personnel to raise awareness and understanding of quality and compliance needs?

Unless and until non-quality personnel are trained or aware of the impact of the product during handling, it would be quite challenging to maintain quality standards throughout the product's shelf life. Training is one of the best ways to raise awareness, but it is not easy as it may differ from region to region. It can be advantageous to create a short video for product handling, including the impact of the product on the patient and its consequences.

The mindset of the non-quality personnel has to change through a continuous awareness and training program. If non-quality personnel are not adequately trained, product quality can be adversely affected, which will have a major impact on patient safety, leading to critical complaints. In turn, patients will be at risk if such a product is given.

Lupin Pharmaceuticals - Pune, India

4. How will future improvements in digital transformation impact supply chain quality?

I think the digital transformation platform will play an important role and positively impact maintaining the quality standard during transit. Nowadays, digital transformation is quite simple and easy to implement. Of course, there will be challenges from a compliance point-of-view, but it is possible, and this is one of the solutions. Many regulatory agencies are emphasizing digital platforms.

In most cases, non-quality personnel handle the product either during transit or storage. In such cases, monitoring the human handling element would be challenging. Still, it can be simplified through digitalization, and multiple tools are available in the market to monitor the required storage condition during transit, handling, and storage. Digital platforms will help to minimize patient risk and assure patient safety.

5. At the upcoming LogiPharma Asia conference in June, what will you speak about?

I'm going to share my experience on Tehnco-commercial Impact on 'Cold Chain Management – Techno-Commercial Impact.'

6. What are 2 reasons why Logipharma Asia should not be missed?

Firstly, Logipharma Asia is renowned for its quality program and pooling the best talents from different regions as speakers to make the event unique.

And secondly, as this will be an international event, participants, speakers, service providers, and others will interact and be curious to learn about current progress in the supply chain. Logipharma Asia is the best platform to update our knowledge and connect with service providers to understand new technology.

About Lupin Pharmaceuticals

Lupin is a global pharmaceutical company offering Branded and Generic Formulations, Biosimilars and Active Pharmaceutical Ingredients (APIs). Founded over 50 years ago, Lupin today is a significant player in the US, India and Japan and additionally in other counties within APAC, EMEA and LATAM. It holds a global leadership position in Anti-TB and Cephalosporin segments.

About Cold Chain Platform

Cold Chain Platform (CCP) is 100% focused on cold chain and logistics in the bio-pharmaceutical, life science, and healthcare industries. CCP shares global cold chain and logistics information and valuable resources to help companies acting in the pharmaceutical space find the right cold chain and logistics partners for their supply chain management.

About LogiPharma Asia

LogiPharma Asia is a premiere event for pharma, biotech, and medtech supply chain executives in Asia and provides an exceptional opportunity for innovators in the industry to learn, benchmark, and share their best practices with peers in a highly interactive format. By bringing together heads of supply chain, operations, and logistics from Asia's most successful pharmaceutical and life science companies, LogiPharma aims to promote deeper collaboration among industry players, leading to more effective and efficient supply chain management.

As a media partner, Cold Chain Platform readers can attend the summit at a discount. Simply quote CCP15 to enjoy 15% off prevailing ticket rates.

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About Shaligram Rane

Vice President & Site Head Quality, Lupin Pharmaceuticals

Shaligram is currently working with Lupin as Vice President and Head of the Biotech Quality Department in Pune, India. He has previously worked at the Quality and GMP departments of various renowned organizations like Intas, Dishman, Cadila, Glenmark, Sun, Aarti, and with Goverment Polytechnic College.

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