Visnova’s GLP Compass: Guiding Emerging Pharma Minds from Books to Bench

🌱 Visnova Insights: Ensuring Safety Beyond the Clinic – The Role of Non-Clinical Health & Environmental Safety Studies 📘 Introduction In pharmaceutical and agrochemical research, non-clinical health and environmental safety studies are essential. They ensure that new drugs and chemicals are safe for both human and environmental health— before they ever reach clinical trials . These studies follow Good Laboratory Practice (GLP) to guarantee scientific accuracy and regulatory compliance. 🔬 Table 1: Overview of Non-Clinical Safety Studies Purpose Examples Outcome/Use Identify toxic effects Acute, sub-chronic, chronic toxicity tests Determine organ-specific toxicity Establish exposure limits Dose-response studies Identify NOAEL (No-Observed-Adverse-Effect Level) Study metabolism and kinetics ADME studies (Absorption, Distribution, Meta...

Understanding the Organizational Process in a GLP-Compliant Lab In the context of Good Laboratory Practice (GLP) and Contract Research Organizations (CROs), the term "organizational process" holds significant weight. It is the foundation on which reliable, reproducible, and regulatory-compliant research is built. But what exactly does it mean? 📌 Definition : The organizational process refers to the structured system of planning, executing, monitoring, and documenting all activities within a laboratory or research setting to ensure studies meet their scientific and regulatory objectives. 🔍 Why Is It Important in GLP-CROs? In GLP environments, data integrity and accountability are non-negotiable. The organizational process ensures: ✅ Each study is pre-approved and methodically designed ✅ Roles and responsibilities are well-defined ✅ Resources are efficiently allocated ✅ Every step is documented, reviewed, and auditable 🔄 Key Components of the Organizational Process Step Wha...

  Introduction A Quality System in an analytical laboratory ensures that all scientific data generated is credible, reproducible, and in line with regulatory expectations. Just as GLP (Good Laboratory Practice) forms the foundation of non-clinical research, a robust quality system guarantees operational integrity, especially in Contract Research Organizations (CROs) where precision and compliance are non-negotiable. What is a Quality System? A Quality System is an integrated framework of policies, processes, SOPs, and controls designed to meet regulatory standards such as GLP, GMP, ISO 17025, and ICH guidelines. It governs how work is planned, performed, documented, and reviewed to ensure reliability and traceability of data. Key elements include: Document Control Change Management Deviation and CAPA Management Internal Audits Training Records Data Integrity Measures Archival and Record Retention Quality Systems in CRO Labs In CROs, particularly t...

Introduction Good Laboratory Practice (GLP) is a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported. For pharmacy students aspiring to enter the pharmaceutical industry, especially in Contract Research Organizations (CROs), understanding GLP is crucial. What is a CRO? Contract Research Organizations (CROs) are independent organizations that provide support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. CROs play a key role in analytical method development, validation, and GLP-compliant studies. The Role of GLP in Analytical Labs GLP ensures the integrity and reliability of data generated by analytical labs. Key elements include: Standard Operating Procedures (SOPs) Documentation and traceability Equipment qualification and calibra...