Standard Operating Procedure (SOP) is a document that provides directions on how tasks and processes should be carried out within a company. Standard Operating Procedures (SOPs) are an integral part of the routine operations in the pharmaceutical industry, and every...
The ICH Q10 Pharmaceutical Quality System (PQS) is a guideline that outlines a model for an effective quality management system for the pharmaceutical industry. ICH Q10 provides a comprehensive model based on the International Standards Organization (ISO) quality...
Pharmaceutical Quality Management System (QMS) is a set of procedures and practices contributing to product quality. The QMS must reflect the relevant regulatory requirements applicable to the industry and company. In the pharmaceutical industry, some of the important...
Quality audits are crucial to ensure compliance with regulatory requirements in any industry. Similarly, quality audits are conducted in the pharmaceutical industry to ensure that the complex system of processes and operations of your pharmaceutical company meets...
The change control process is a set of coordinated activities through which the desired change is implemented in an existing function, process, or product in the pharmaceutical industry. Change control aims to involve all the relevant departments for successful change...
Product quality is a key factor for any pharmaceutical organization and the CAPA process helps ensure that the products are of high quality. The CAPA process plays an important role in the quality management system of any pharmaceutical company. It helps to identify,...