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...
The ICH Q10 pharmaceutical quality system document is an all-inclusive manuscript that serves as a model for an efficient quality management system (QMS) in the pharmaceutical industry. By implementing the ICH Q10 pharmaceutical quality system you will demonstrate to...
Standard Operating Procedures (SOPs) are an integral part of the day-to-day operations in the pharmaceutical industry, and every department must have its own SOPs. It is against regulatory requirements to execute operations without a properly developed, approved, and...
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,...