The FDA divides Life science products up into different categories with their associated centers. These centers, for medical products, are Drugs, Devices, and Biologics. If a product applies to more than one of these centers, it is sent to the office of combination products which serves as the focal point for medical product classification and assignment issues.
Every company knows the importance of maintaining accurate and complete data of a high quality over periods of time and across all different formats. Having a good data integrity plan is essential and can save an organization time, effort, and money all while providing the security that the organization is not operating and making decisions with incorrect or incomplete data.
FMEA is an acronym that stands for Failure Mode Effect and Analysis which is a method for determining any and all possible points of failure in a design, process, or product. This is a combination of Failure Modes, which is a way in which something could potentially fail and result in defects, and an Effects Analysis which determines the consequences of those failures. During this, failures are prioritized by how serious their consequences are, their frequency, and how they are detected. Failures are eliminated based on their priority, starting with the higher priorities.
When issues occur that have the potential to impact product quality, Quality Assurance Reports (QAR) are generated to determine what happened, why it happened, and how to prevent it from happening again. An investigation is launched to determine this and what the potential impacts are.
Evolution is the process of how a species changes over time in response to their environment. Often termed “Survival of the Fittest”, the topic was studied most famously by Charles Darwin. While it is present across all species, one of the biggest impacts it can make is the change in a microorganism’s genome to resist antimicrobial products. These are used to treat and cure infections and sterilize surfaces among others. For this reason, antimicrobial resistance (AMR) has become a global concern.
The FDA has recently been putting a much greater emphasis on working smarter not harder when conducting clinical trials. Types of clinical trial designs called Complex Innovative Trial Designs (CIDs) which come in response to the rapidly changing drug development environment have recently been getting a lot of attention. These designs allow clinical trials to answer more questions in less time.
Maintenance of equipment is always essential to any manufacturing process. Breakdowns can wreak havoc on any process and can cause all kinds of issues for the manufacturer. Therefore, being able to perform regular maintenance on equipment that is prone to breaking down, has areas/processes that are at high risk of malfunctioning, or is extremely essential to the process before it breaks down allows for time and cost savings as well as maintaining product quality. This is known as Preventive Maintenance (PM).
Prior to drugs being commercially available, manufacturers often conduct pre-clinical studies to obtain data ensuring that their drug is both safe and effective. Once the data has been collected, manufacturers then submit an Investigational New Drug Application (IND) to the Department of Food and Drug Administration (FDA). Per the FDA, “An IND is a request from a clinical study sponsor to obtain authorization from the FDA to administer an investigational drug or biological product to humans”.
While having robust compliance policies and procedures in place is essential for meeting regulatory requirements, it's equally important to establish a culture of compliance within your organization.
A culture of compliance means that every employee understands the importance of compliance and is committed to upholding it in all their work. Here are some tips for establishing a culture of compliance...
One of the biggest and most important aspects of quality management is a system to monitor changes and how they impact the product. Change management is an approach for changing processes or products in a way which adheres to regulatory standards by ensuring stability and consistency throughout processes. It applies across all changes within a process and throughout an entire products life cycle.
One of the most common techniques to prevent contamination of products and reduce quality impacts in the pharmaceutical industry is called aseptic gowning. Humans are the biggest sources of microbial contamination in cleanroom environments and therefore proper gowning procedures are essential to ensuring product quality. Proper training, education, hygiene, qualification, and authorization must be put in place and be required for entry to all clean room environments...
Having high quality standards is vital to any organization but is even more essential in the pharmaceutical industry. Practices that are governed by these standards are commonly called Good Manufacturing Practices (GMP) and ensure consistent and controlled production of products. These practices govern all aspects and procedures within production and provide documented proof that procedures are consistently followed during the manufacturing processes every time products are made. They are designed to minimize risks throughout the manufacturing process that are not able to be eliminated in final product testing so that pharmaceuticals are safe for use...