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Biologics Manufacturing: The Cleanroom Design and Qualification Process
The cleanroom design and qualification process for biologics manufacturing is crucial to maintaining the integrity and safety of biologic products. Given the complex nature of…
Biological Intermediates: The Regulatory Expectations
Biologics intermediates are life-saving products that can vastly improve patients’ quality of life. As such, regulatory agencies must ensure their quality, safety, and efficacy. The…
Bioanalytical GLP Consultants
Bioanalytical GLP Consultants Bioanalytical GLP consultants are professionals who provide guidance, support, and expertise to organizations that need to comply with Good Laboratory Practice (GLP)…
Beyond Compliance: How to Use QMS to Drive Business Growth and Success
An effective Quality Management System (QMS) is crucial for organizations to ensure that their products and services meet or exceed customer expectations. The prime components…
Best 21 Ways Artificial Intelligence Is Advancing Life Sciences
Artificial Intelligence (AI) has become a game-changer in various industries, and the life sciences field is no exception. The application of AI in life sciences…
Autoclave Validations: Regulatory Requirements, Autoclave Requirements and Usage, Step-by-Step Installation Guide
Autoclave Validations Autoclave validation ensures that sterilization processes in pharmaceutical, life sciences, and other regulated industries comply with regulatory requirements. Below, I will cover the…
Aseptic process simulation (APS)
Aseptic process simulation (APS) is a critical component of the validation process in pharmaceutical manufacturing, particularly in producing sterile products. The goal of aseptic processing…
Artificial Intelligence in the Pharmaceutical Industry | Guide
The convergence of artificial intelligence (AI) and the pharmaceutical industry has led to significant advancements in drug development, manufacturing, and patient care. AI’s ability to…
Analytical Instrument and System Qualification (AISQ)
Purpose USP <1058> provides a scientific and risk-based framework for the qualification of analytical instruments and systems to ensure they are fit for their intended…
