Good Manufacturing Processes (GMPs) for Quality Assurance GMPs are the backbone of consistent and controlled production of products, meeting the required quality standards for their intended use. They cover both production and quality control, ensuring excellence in the manufacturing process. Good Clinical Practice (GCP) for Ethical Trials GCP sets the gold standard for designing,…
Good Laboratory Practices (GLP) play a crucial role in ensuring the integrity, reliability, and ethical conduct of nonclinical safety studies. Let’s delve into why companies emphasize GLP compliance: 1. Regulatory Requirements: GLP regulations provide a standardized framework for conducting nonclinical studies in drug development. Regulatory agencies, such as the FDA and EMA, mandate…
1. Test facility, organization and personnel 2. Quality Assurance (QA) program 3. Facilities 4. Apparatus materials and reagents 5. Test systems – Appropriate design and adequate capacity of apparatus used for the generation of data – Integrity of physical/chemical test systems – Proper conditions for storage, housing, handling and care –…
1. Always wear appropriate personal protective equipment (PPE) such as gloves, lab coat, and safety goggles. 2. Familiarize yourself with the laboratory’s emergency procedures and know the location of safety equipment like fire extinguishers and eyewash stations. 3. Keep your work area clean and organized to prevent accidents and cross-contamination. 4. Label all containers clearly…
