Taking a quick look at the internet for FDA compliance problems will result in a multitude of hits. With all the data available, we can now take a look at the top issues in the pharmaceutical industry that lead to 483 observations.
The top 10 FDA 483 observations were:
- Quality audits
- CAPA documentation
- Process validation
- CAPA procedures
- Design validation
- Control of Nonconforming product
- Management review
- CAPA – analyzing processes
So…what is FDA compliance? Is it making product that meets specification? Is it doing appropriate testing? Is it taking care of issues with products already released? The simple answer – yes! Those items and many, many more will keep you in a state of compliance.
What’s the secret? No secret – just knowing these
The FDA requires adequate and appropriate GMP training for people involved in the manufacture, testing, warehousing, handling, etc. of pharmaceuticals. The people who work in these areas must also have an appropriate combination of education and experience. If an individual does not meet these criteria, then all their work is subject to question.
Appropriate training directly affects the product being manufactured. Inadequate training could cause the FDA to declare the subject product adulterated per the FD&C Act. This means that the product would be a violation of Federal Law.
GMP regulations contain specific requirements for documentation and recordkeeping. There must be established systems for the control of detailed documentation, compilation, and storage of records related to the manufacture and testing of each batch of product. Good documentation and recordkeeping procedures help ensure the production of a safe, high quality, and effective product.
#3 Process Control
Process control means having established systems that consistently produce a quality product. This means that having an understanding of what is critical to the process and how to control those critical steps. Validation of processes is documented proof of process control-proof that the process does what it purports to do. FDA regulations require validated processes, because validated process methods will consistently produce safe and effective products that meet pre-determined criteria.
#4 Equipment Control
Properly installed (IOQ/PQ), well-maintained (PM), and properly cleaned equipment will produce products that meet their intended specifications. Having knowledge of what type of equipment you need is critical to purchasing the right equipment. Knowing the critical parameters of the process will provide the proper understanding of the needs for your equipment.
#5 Having Independent Quality Control and Quality Assurance People
Whether your facility is producing drugs, medical devices, or biologics, FDA compliance will require that there be a Quality Control (QC) or Quality Assurance (QA) department established within the manufacturing facility. This quality oriented group will approve or reject all materials, review specifications and procedures, review changes, and test and release finished product
The Quality department must exist autonomously and report to management separately from the manufacturing or testing functions. In this way, FDA compliance requires an independent group to ensure that only safe and effective products reach the marketplace.
#6 Effective Change Control
This FDA compliance requirement states there are to be no changes to a product, its materials, process, facility, critical utilities, major equipment, test method, documentation, or specification, unless the Quality department approves it. This requirement is designed to ensure that the product is as safe and effective as it had been before the change was made.
Free FDA 483 Action Package
Compliance Insight has created a free FDA 483 Action Package to help you respond to a FDA 483. Click the button below to learn more and download you copy today.