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OOS Investigation Tools: Streamlining Out-of-Specification Investigations

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OOS Investigation Tools: Streamlining Out-of-Specification Investigations Out-of-specification (OOS) events are critical occurrences in pharmaceutical manufacturing, representing deviations from established specifications and potentially impacting product quality and patient safety. Efficient and thorough investigations are crucial to identify root causes, prevent recurrence, and ensure product compliance. This post explores essential tools that streamline OOS investigations. Key Tools and Examples of OOS investigation Tools: 1. Electronic Data Capture (EDC) Systems:   These systems are crucial for managing clinical trial data, but their principles of data integrity, audit trails, and secure storage are highly relevant to OOS investigations. Veeva Vault EDC: Veeva is a well-established name in the life sciences industry. Vault EDC is a cloud-based platform specifically designed for clinical data management. Its features like audit trails, electronic signatures, and version contro...
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Recent Major Updates in Pharmaceutical Industry

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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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