New Chemical Entities (NCEs) in Pharmaceutical Drug Development

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When it comes to the world of pharmaceuticals, you may have heard the term “New Chemical Entity” / NCE under Drug Development procedure. But what exactly does this term mean? In this article, we will explore the understanding on NCEs, exploring their significance & understanding their role in the development of innovative medicines.  Fig.1 : New … Read more

5 Common Challenges in Pharma Drug substance Process Validation

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Pharmaceutical process validation is a critical aspect of drug substance manufacturing; that ensures the consistency and reliability of production processes.  Pharmaceutical process validation However, various challenges may arise during this validation process. Here, are five common challenges in pharmaceutical process validation for drug substance manufacturing and potential strategies to overcome them: 1. Process Variability/Complexity 2. Scale-Up … Read more

10 Key Steps for Successful Process Validation in Pharma

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In the ever-evolving landscape of the pharmaceutical industry, ensuring the quality and reliability of processes is paramount. One crucial aspect that stands at the forefront is the process validation—a meticulous journey that guarantees the efficiency and safety of pharmaceutical manufacturing. 10 Key Steps for Successful Process Validation in Pharma In this article, we will unravel … Read more

Clinical Trials: A Key to Pharmaceutical Development / Advancement

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  Introduction to Clinical Trial?   When we talk about the pharmaceutical development, Clinical trial is a significant term. What is clinical trial? This term can be defined as; the clinical study of health and illness in people.  Fig. 1 : What is Clinical Trial? In previous article pharmaceutical development, we understand the Path to Pharmaceutical … Read more

Pharmaceutical Quality Management System: Excellence in Drug Manufacturing

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 A strong and effective quality management system (QMS) is perhaps more important than ever in the fast changing pharmaceutical industry of today. Pharmaceutical manufacturing is built on a solid QMS, which makes sure that each stage of production complies with strict quality standards, legal requirements, and patient safety. Pharmaceutical firms are currently carefully designing their … Read more

The Evolution of Drug Substance Development

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 The
development of drug substances has evolved significantly over the years. In the
past, drug substances /API  were often
discovered through serendipity or by isolating compounds from natural sources.
However, modern drug discovery and development have become more systematic and
technologically advanced.

Evolution of Drug Substance Development
Figure 01:  Evolution of Drug Substance Development

The
development of drug substances has evolved significantly over the years. In the
past, drug substances /API  were often
discovered through serendipity or by isolating compounds from natural sources.
However, modern drug discovery and development have become more systematic and
technologically advanced.

In
the pharmaceutical industry’s endeavor to research and produce effective
medicines, the growth of drug substance development is a crucial aspect. This
procedure has significantly improved throughout time, moving away from outdated
techniques and toward more modern, precise strategies. 

These developments have
sped up the process of developing new drugs while also improving the efficacy
and safety existing pharmaceutical ingredients. The significance of this
evolution rests in its capacity to solve unmet medical needs, enhance patient
outcomes, and open the door for novel treatments that attack complicated diseases,
ultimately enhancing the quality of life for millions of people around the
world.

Challenges
and Innovations

Despite
the remarkable progress in drug substance development, the pharmaceutical
industry faces several challenges. These include:

Drug
substances are crucial to modern healthcare, but their creation and production
are not without difficulties and ongoing improvements. Because of changing
regulatory requirements  / regulations
and rising demand for personalized medicine, the pharmaceutical business must
work to ensure the safety, effectiveness & quality of therapeutic
substances.

The use of cutting-edge technologies like artificial intelligence
(AI) and machine learning for drug discovery, the emergence of novel drug
delivery systems to enhance bioavailability, and the adoption of continuous
manufacturing processes to improve efficiency and lower costs are all examples
of innovations in the development of drug substances / API. In order to lessen
its influence on the environment, the industry is also placing more and more
emphasis on sustainability and green chemistry techniques.

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Drug Substance in Pharmaceuticals!! Unveiling Its Vital Role

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In the intricate world of pharmaceuticals, every pill, capsule, or vial of medicine begins its journey as a carefully crafted concoction of various components. At the heart of this intricate process lies a fundamental element known as the “drug substance” or “active pharmaceutical ingredient” (API). In this comprehensive article, we will delve into the significance of … Read more

Computer System Validation: Navigating Regulatory Compliance

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Computer
system plays a key role in many businesses from managing critical data to
managing complex processes. The seamless integration of advanced technology
& regulatory compliance is important in the ever-changing world of
pharmaceuticals, biotechnology & medical devices.

Compliance
to regulatory agencies regulations & recommendations is not only needed;
but it is also important to ensure the integrity, security & reliability of
these systems. In this broad article we tried to dig into the subject of
“Computer System Validation (CSV)” within the context of FDA
standards, highlighting its importance, difficulties, and best practices.

Computer System Validation: Navigating Regulatory Compliance
Figure:01 Computer System Validation: Navigating Regulatory Compliance

In this view
article is furnished with the below broad topics and area;

  1. The Significance of Computer System Validation
  2. Navigating Regulations of FDA (USA),
    ICH, EU & WHO
  3. Challenges in Computer System Validation
  4. Best Practices for Successful Computer System Validation.


1.  The
Significance of Computer System Validation

Computer
systems are the backbone of modern pharmaceutical & healthcare operations,
those are contributing to efficient data management, accurate reporting and
streamlined processes. However, as these systems have become increasingly
complex; the potential for errors, data breaches, and operational disruptions
grows. “Computer System Validation” serves as the safeguard against
these risks, which ensuring that the systems used in critical functions; like
Manufacturing, Quality Control, Clinical Trials, and Regulatory Submissions.

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Drug Substance and Drug Product Manufacturing Flow: Discovery to Delivery

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In the world of pharmaceuticals, the drug substance manufacturing process is a critical component in bringing life-saving medicines to patients. This complex process involves several steps, adherence to stringent rules, and upholding the highest standards of quality. This process is based on the basic Good Manufacturing Practice (GMP) principles i.e. SISPQ; which means a drug … Read more

What is Difference? Verification v/s Validation in Pharmaceutical Industry

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In the pharmaceutical industry, term verification and validation are being often used, this article is furnished just for the understanding the difference between these two i.e. Verification V/s Validation. Figure: 1 Verification and Validation How to Define Verification and Validation? Validation and verification these are two separate / individual processes, each of these have their own … Read more