• There are no suggestions because the search field is empty.

Life Sciences Blog

Whether you're in pharma, biotech, medical devices, or any other industry, our diverse services and expert guidance are designed to keep you informed and ahead of industry trends. Dive into our content and stay connected with the latest advancements and best practices.

Life Sciences Blog

Why-self-inspections-or-internal-audits-are-essential-for-your-QMS-1536x864
Circles_banner_news&events-1
Industry
Services
Filter
All
Services

Container Closure Integrity Testing (CCIT): why it’s essential for pharmaceutical packaging

Imagine this: a life-saving drug reaches a patient, but due to a small, undetected defect in its packaging, the medicine is no longer sterile. The...

Sterilization Validation: A Practical Guide to Ensuring Safety and Compliance

Sterilization validationis a vital process in the healthcare and pharmaceutical industries. It ensures that sterilization methods are not just...

Maintaining Validation Excellence: Continuous Improvement Through Periodic Validation Reviews in Pharma

Implementing PIC/S Standards in Hospital Cleanrooms: From Regulation to Application

Starting January 1, 2026, hospital pharmacies globally must comply with PIC/S standards for their pharmacy preparations, specifically requiring the...

SCADA Automation in Pharma: Boosting Efficiency and Compliance

Imagine a world where countless operators meticulously monitored dials and switches, ensuring the precise production of life-saving...

ICH Q2(R2) Validation of Analytical Procedures: An Overview of the Revised Guideline

Introduction Did you know that the precision of analytical methods directly influences the safety and efficacy of pharmaceutical products? Understanding...

Continuous manufacturing in the pharmaceutical industry: enhancing drug production

A significant shift towards continuous manufacturing (CM) is currently underway in the pharmaceutical industry. Unlike the more commonly used batch...

Qualifying a new GMP facility: from pitfalls to best practices

In pharmaceutical production, a GMP (Good Manufacturing Practices) facility stands as a testament to stringent quality control and precision....

Navigating Project Complexities: QbD’s Project Management Process for Qualification and Validation Projects

In the world of life sciences, ensuring the safety and efficacy of products is paramount. Qualification and validation projects play a pivotal role...

Mastering Cleanroom Qualification: navigating the latest regulatory updates 

In 2022, significant updates were made to the main standards that impact the qualification of cleanrooms. These updates include: {% module_block...

Analytical Method Validation: are your analytical methods suitable for intended use?

What is Analytical Method Validation? Analytical method validation is a critical process in the pharmaceutical, biotechnology, and food industries to...

Qualification of laboratory equipment: key considerations and challenges

The introduction of a new product into your company’s portfolio may require expanding your existing laboratories or even building a new laboratory to...

Medical Device and IVD industry trends for 2023

At the beginning of yet another new year, it is always interesting to take a moment to reflect on the growth and future prospects within the life...

Medical Device development: the importance of Design Transfer and Process Validation

Bringing a Medical Device to market involves many hurdles, including medical device design and medical device development. While the design and development...

The importance of high-quality gas distribution networks for critical process gases, even in the early development phase

Although no single best practice, standard, or guideline has been specifically enforced, competent authorities, such as the FDA, are increasingly...

Compressed gases in pharmaceutical manufacturing: best practices in microbial monitoring

Compressed gas standards The latest draft of Annex 1, Manufacture of Sterile Medicinal Products, introduced the concept of a “contamination...
data-not-found No Blog Post Found!
circle-box