As the pharmaceutical industry continues to grow and evolve, risk assessment has become an increasingly important aspect of pharma manufacturing. It is critical that pharmacists have a thorough understanding of the risks involved in the manufacturing process, as they play an important role in ensuring the safety and efficacy of medications. A comprehensive risk assessment […]
In the modern world, it is essential that organizations take proactive steps to ensure that their operations are conducted in a safe and compliant manner. This is especially true in low and middle-income countries, where the risk of non-compliance is higher due to the lack of regulation and enforcement. A risk-based inspection (RBI) is a […]
Failure mode and effect analysis (FMEA) is a technique used to identify the risk of failure in a product or process during design, manufacture, and service. It’s also referred to as Failure Modes Analysis (FMA), Factor Failure Analysis, and Failure Cause Analysis. It’s an easy way to highlight potential issues with your product or process […]
The Corrective and Preventive Actions (CAPA) effectiveness review and acceptance process is an important part of an organization’s quality management system, and helps to ensure that CAPAs are designed and implemented effectively. This process can also help to identify potential improvements to an organization’s quality management system. Review and acceptance are crucial to the process […]
Risk-based inspection (RBI) is a methodology that is based upon the concept of rating manufacturing sites on the basis of an estimated risk that they may pose to patients and consumers of medicines. The idea is that by identifying and assessing the risks posed by different manufacturing sites, regulatory authorities can better focus their resources […]
Pharmacists are among the highest respected professionals in the healthcare industry. They are one of the few people that are allowed to be in contact with prescription medications. The responsibility of a pharmacist is to manage the safe distribution of drugs to, from, and within the hospital, clinic, or pharmacy. They provide the healthcare providers […]