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The Master Guide to Quality Risk Management (QRM) in Sterile Manufacturing: An ICH Q9 Perspective

by Prashant Suresh Devmore
  1. Introduction: From Reactive to Proactive Quality ​In the high-stakes environment of sterile injectables, waiting for a failure to occur is not an option. Quality Risk Management (QRM) is the systematic, proactive process of assessing, controlling, communicating, and reviewing risks to product quality. Drawing from my 11+ years of experience navigating USFDA and MHRA audits.  I have seen that a robust, scientifically sound QRM program is the fundamental difference between a minor observation and a severe Warning Letter. ​ 2. The Regulatory Bedrock: Understanding ICH Q9(R1) ​The International Council for Harmonisation (ICH) provides the global standard through the Q9 guideline. The recent revision, ICH Q9(R1) , emphasizes reducing subjectivity and ensuring a scientific basis for risk assessments. ​ Patient Protection: The core purpose of QRM is to safeguard the patient; all evaluations must link back to patient health. ​ Proportionality: The level of effort and doc...
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Recent Major Updates in Pharmaceutical Industry

by Prashant Suresh Devmore

Recent Major Updates In Pharmaceutical Industry

1. Sanofi's New Polio Vaccine Approval in India:

   - Sanofi has received approval for a new injectable polio vaccine (IPV) called IMOVAX-Polio in India. This comes after the company ceased production of its ShanIPV vaccines in India, which raised concerns about potential shortages in the country's IPV supply.

#Recent-updates-in-pharmaceutical-industry

2. Global Private Equity Firms Eyeing Bharat Serums and Vaccines (BSV):

Five global private equity firms, including Warburg Pincus, Permira, EQT, Bain, and TPG, are interested in bidding for Bharat Serums and Vaccines (BSV). The Mumbai-based biopharmaceutical company is seeking over $1 billion. Advent International, the current owner, acquired BSV in 2019 and now plans to sell it¹.

3. Collaboration for Oral Polio Vaccines Production:

Bharat Biotech has collaborated with the Netherlands-based **Bilthoven Biologicals B.V., a wholly-owned arm of Serum Institute of India, to strengthen the production and supply security of oral polio vaccines (OPVs) within India and globally.

4. Lupin's New Chief Quality Officer:

Dr. Ranjana Pathak has been appointed as Lupin's chief quality officer, succeeding Johnny Mikell. Dr. Pathak brings 30 years of experience in quality management from her previous roles at Cipla, Watson/Actavis, and Endo Pharmaceuticals.

5. Strategic Focus on the Indian Market by Sanofi:

   - Sanofi is prioritizing the Indian market, with a focus on areas such as diabetes, consumer health, and innovation. Under new leadership, they plan to launch one or two products in India every year.

6. India's Return to Penicillin G Production:

After three decades, India is set to make Penicillin G again, driven by the government's Production-Linked Incentive (PLI) push.

These updates reflect the dynamic nature of the pharmaceutical industry, where companies are constantly innovating, collaborating, and adapting to meet global healthcare needs.

References:

(1) Pharmaceuticals Industry: Get latest Pharma Industry News, Top

(2) Top 10 Pharmaceutical Industry Trends in 2024 | StartUs Insights

(3) Six new pharmaceutical industry trends | McKinsey. gy.

(4) Pharma breakthroughs: 10 novel drug approvals that made headlines in ...

(5) en.wikipedia.org. .

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