Introduction: A change control is a notable function in climate pharmaceutical, which calls for adjustments to system, processes or products that are conducted in a professional manner in a way that respects regulatory, quality and safe compliance. Nonetheless, managing change effectively has its own issues. Pharmaceuticals as an industry is a sphere of activity which is rather stiff and which […]
Change control is a documented disciplined methodology utilized by the Pharmaceutical Industry to implement, monitor, approve and report changes affecting processes, systems, equipment, documents, and products. It also ensures that any change embraces the right process so as to retain the quality, safety and the compliance of drug products. From respect of change control procedures, the pharmaceutical firms can be […]
Introduction. Change control is a documented disciplined methodology utilized by the Pharmaceutical Industry to implement, monitor, approve and report changes affecting processes, systems, equipment, documents, and products. It also ensures that any change embraces the right process so as to retain the quality, safety and the compliance of drug products. From respect of change control procedures, the pharmaceutical firms can […]
Purpose: This Standard Operating Procedure (SOP) establishes a comprehensive framework for ensuring data integrity across all processes within the pharmaceutical industry. It aims to uphold regulatory compliance, product quality, and public safety by maintaining accurate, complete, and reliable data. Scope: This SOP applies to all departments and personnel involved in data generation, recording, processing, review, and retention within the pharmaceutical […]
Introduction: It is therefore notable to realize that in the pharmaceutical industry compliance, product quality, and patient safety is of great importance. CSV also acquires a significant value to achieve these objectives. CSV confirms that the implemented computer systems operate in a desired manner and meet the regulatory standard. The present article explores the notion of validation of computer systems, […]
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 […]
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 […]
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 […]
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 […]
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 […]
