|
Indian pharma integrates business intelligence to optimize product quality for supply chain resilience
|
|
Nandita Vijayasimha, Bengaluru
August 30 , 2024
|
|
|
Indian pharmaceutical sector can significantly enhance product quality and supply chain resilience by integrating Business Intelligence (BI) and implementing technology, said Vishal Sharma, co-founder and director, Vienni Training & Consulting LLP and member, RAQAB, Parenteral Drug Association Inc.
Quality issues continue to be the leading cause of supply disruptions. Resolving these problems requires establishments to devote time and resources to implement remedial actions, he added.
Quoting the US FDA report on Drug Shortages: Root Causes and Potential Solutions (Revised) (2020), Sharma said that it indicated 62 per cent of drugs that went into shortage between 2013 and 2017 were linked to manufacturing or product quality issues. These issues included substandard manufacturing establishments and quality defects in finished products.
Therefore Quality Management Maturity (QMM) is an important tool, used by many pharma companies to integrate business intelligence, manufacturing operations, quality practices, technological advancements to optimize product quality, enhance supply chain resiliency and drive continuous improvement.
We see that business intelligence helps pharma companies in many ways. It frees up time and resources and will enable quality compliance personnel to focus on preventive measures rather than take reactive measures, Sharma said.
It helps to identify areas of improvement which can aid in audit preparedness. It improve decision-making by harmonizing processes to better manage quality. It manages regulatory challenges, reduce risk, and align with regulatory expectations throughout product lifecycle. Quality team members can take faster, better decisions and quickly identify areas of concern to hone in on them for maximum impact. One of the key impacts is on reduction in the cost of quality.
A significant decrease is achieved by advancing even one level in quality maturity, said Sharma as reported IQVIA Quality Maturity Model for Life Sciences. For instance, development process accounts for 25-40 percent of revenue. The estimated improvement shown was 16 per cent. To control quality issues, with an allocation of 18-24 per cent of the revenue, the improvement seen was around 7 per cent. Integrating technology, with 12-17 per cent revenue allocation, 4-6 per cent of improvement was seen, he said.
High levels of maturity, such as in processes, systems, or organizational culture, often require strong management commitment and ongoing support. The PDA India Chapter to this end, seeks the attention of the pharmaceuticals and biologics leaders to enable key resources from their organization to maximize benefits of an upcoming conference and workshop on quality management maturity and supply chain resilience to be held from September 18 to 20, 2024 at Hotel ITC Gardenia, Bengaluru. The workshop and conference is expected to have participation from the regulatory officials from CDSCO and US FDA offices along the industry, allied sector and service providers.
To well-orchestrate QMM practices, organizations need to consider participation of Heads of departments of human resources, engineering, quality, operations, R&D, MS&T(Manufacturing Science & Technology), Supply Chain, and Regulatory verticals within the company, said Sharma.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|