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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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Aurobindo Pharma -Walk-In Drive for Multiple Positions On 14, March 2020

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Aurobindo Pharma -Walk-In Drive

Aurobindo Pharma -Walk-In Drive for Multiple Positions On 14, March 2020
Aurobindo Pharma -Walk-In Drive for Multiple Positions On 14, March 2020

Aurobindo Pharma information:

  • 500 + ANDAs filed
  • 360 + Final approvals
  • Manufacturing facilities approved by US FDA, UK MHRA, TGA Australia, MCC-SA, EMA, and ANVISA for both APIs and Formulations
  • 1560 + Scientists & Analysts
  • Leveraging World-Class Talent in a Global Team across 7 R&D Centers, we successfully launch affordable products across multiple Therapeutic Areas and Delivery Technologies

Aurobindo Pharma Overview: 

  • Founded in 1986 by Mr. P.V. Ramprasad Reddy, Mr. K. Nityananda Reddy, and a small group of highly committed professionals, Aurobindo Pharma was born of a vision. The company commenced operations in 1988-89 with a single unit manufacturing Semi-Synthetic Penicillin (SSP) at Pondicherry.
  • Aurobindo Pharma became a public company in 1992 and listed its shares on the Indian stock exchanges in 1995. In addition to being the market leader in Semi-Synthetic Penicillin’s, Aurobindo Pharma has a presence in key therapeutic segments such as neurosciences (CNS), cardiovascular (CVS), anti-retroviral, anti-diabetics, gastroenterology and Anti-biotics
  • Through cost-effective manufacturing capabilities and a few loyal customers, the company also entered the high-margin specialty generic formulations segment. Today Aurobindo Pharma has evolved into a knowledge-driven company manufacturing active pharmaceutical ingredients and formulation products. It is R&D focused and has a multi-product portfolio with manufacturing facilities in several countries.
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  • The formulation business is systematically organized with a divisional structure and has a focused team for key international markets. Leveraging its large manufacturing infrastructure for APIs and formulations, a wide and diversified basket of products, and the confidence of its customers, Aurobindo achieved revenue of USD 2.6 billion in FY2017-18. Aurobindo’s 11 units for APIs / intermediates and 15 units (10 in India, 3 in the USA, 1 in Brazil, and 1 in Portugal) for formulations are designed to meet the requirements of both advanced as well as emerging market opportunities.
  • A well-integrated pharma company, Aurobindo Pharma features among the top 2 Pharmaceutical companies in India in terms of consolidated revenues. Aurobindo exports to over 150 countries across the globe with around 90% of revenues derived from international operations. Our customers include premium multi-national companies. With multiple facilities approved by leading regulatory agencies such as USFDA, EU GMP, UK MHRA, South Africa-MCC, Health Canada, WHO and Brazil ANVISA, Aurobindo makes use of in-house R&D for rapid filing of patents, Drug Master Files (DMFs), Abbreviated New Drug Applications (ANDAs) and formulation dossiers across the world. Aurobindo Pharma is among the largest filers of DMFs and ANDAs in India.
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