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January 17, 2025

Data Integrity: Definition, Its Main Categories, Usage, and How It Is Regulated in the Pharma Sector

Introduction Adherence to data integrity constitutes one of the fundamental prerequisites of drug production and quality management. They guarantee that all information that is used, produced and stored during development and manufacturing of drugs is comprehensive, coherent and veracious. Therefore holding to data integrity principles is important to ensure the compliance to regulations, quality of products, and protection of the […]

0 6 min read
January 17, 2025

Standard Operating Procedure (SOP) For Employee Training in a Pharmaceutical Industry

Purpose: This Standard Operation Procedure – SOP provides guidelines on how the training of employees in a pharmaceutical manufacturing firm can be done to conformity with industry standards, and increased staff productivity. Scope: These procedures may affect all the workers at the pharmaceutical manufacturing facility; whether they are new employees or steady employees who have been hired into other positions […]

0 4 min read
January 16, 2025

Procedure for Audit Trail Verification in Analytical Testing Laboratory For Drugs

Introduction Audit trail verification is a critical component in ensuring the integrity and compliance of data in an analytical testing laboratory. It ensures that all activities related to data generation, processing, and reporting are traceable and compliant with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and data integrity requirements, such as those outlined in the U.S. FDA’s 21 CFR […]

0 4 min read
January 16, 2025

HPLC Audit Trail Verification in Pharmaceutical Industry

Introduction High-Performance Liquid Chromatography (HPLC) is a critical analytical technique widely used in the pharmaceutical industry for the analysis of raw materials, intermediates, and finished products. Given its importance, ensuring the integrity and traceability of data generated by HPLC systems is essential to maintain compliance with regulatory standards such as FDA’s 21 CFR Part 11, EU GMP Annex 11, and […]

0 4 min read
January 15, 2025

Audit Guidelines for Assessing Sufficient Qualified Personnel in an Analytical Testing Laboratory

Introduction The adequacy and qualification of personnel in an analytical testing laboratory are critical components of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Personnel competency directly impacts the reliability, accuracy, and compliance of analytical results. Auditors must carefully assess whether the laboratory has sufficient qualified staff to perform its operations effectively and in compliance with regulatory requirements. This […]

0 5 min read
January 12, 2025

Breathless: Uncovering the Causes of Asthma in 1 in 10 People

Introduction Engaging Hook: Start with a powerful statistic (e.g., “Nearly 1 in 10 people worldwide live with asthma. Are you one of them?”). Purpose of the Post: Explain the goal of the article—to educate readers on asthma, its causes, and how to manage or prevent it. Why It Matters: Highlight the prevalence and growing impact of asthma on global health. […]

0 2 min read