The EU GMP Annex 1 has made one message unmistakably clear: in sterile manufacturing, compliance is ...
Life Sciences Blog
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Life Sciences Blog
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Single-Use Systems (SUS) have become a fundamental component of modern biopharmaceutical manufacturi...
Validation has long been a cornerstone of pharmaceutical quality assurance. Yet for many organizatio...
Since the FDA announced in May 2025 the expansion of unannounced inspections at foreign manufacturin...
In the pharmaceutical industry, maintaining precise temperature control is crucial for ensuring the ...
Cleaning validation plays a vital role in safeguarding patient health — particularly in multiproduct...
Did you know that performing an Analytical Method Transfer (AMT) can significantly benefit your labo...
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Imagine this: a life-saving drug reaches a patient, but due to a small, undetected defect in its pac...
Sterilization validation is a vital process in the healthcare and pharmaceutical industries. It ensu...
Starting January 1, 2026, hospital pharmacies globally must comply with PIC/S standards for their ph...
Imagine a world where countless operators meticulously monitored dials and switches, ensuring the pr...
Introduction Did you know that the precision of analytical methods directly influences the safety an...
A significant shift towards continuous manufacturing (CM) is currently underway in the pharmaceutica...
In pharmaceutical production, a GMP (Good Manufacturing Practices) facility stands as a testament to...
In the world of life sciences, ensuring the safety and efficacy of products is paramount. Qualificat...
In 2022, significant updates were made to the main standards that impact the qualification of cleanr...
What is Analytical Method Validation? Analytical method validation is a critical process in the phar...
The introduction of a new product into your company’s portfolio may require expanding your existing ...
Bringing a Medical Device to market involves many hurdles, including medical device design and medic...
Current regulations require written documentation for all existing products in the company; this doc...
Although no single best practice, standard, or guideline has been specifically enforced, competent a...
Compressed gas standards The latest draft of Annex 1, Manufacture of Sterile Medicinal Products, int...