Did you know that WorkingBuildings is an active partner in ensuring the safety of medically regulated products?
If you are like most, when your head hurts, you reach for whatever painkiller is close by. You may scan the label for the recommended dosage, but, more times than not, you simply deal yourself two pills, pop them in your mouth, and wait for the medicine to take. Any fear you might have over taking the medicine is likely assuaged by some vague awareness that the U.S. Food and Drug Administration regulates the manufacturing of such products. This does not mean, however, that you are aware of the regulatory process or just how the FDA assures that drug manufacturing processes meet a basic set of standards. The purpose of this article is to educate you on the process.
The FDA regulates the quality of medicines very carefully. The main standard for pharmaceutical quality is the Current Good ManufacturingPractice (CGMP) regulation for human pharmaceuticals. Current Good Manufacturing Practices are systems for ensuring that products are consistently produced and controlled according to quality standards. The CGMP system is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
CGMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process—every time a product is made.
These guidelines provide a set of minimum requirements that food and drug must meet to assure that the products are of high quality and do not expose consumers to any risk.
The guidelines follow basic principles:
- Controlled environmental conditions
- Validation of critical processes to ensure consistency and compliance with specifications
- Any changes to process are evaluated; changes that impact quality are validated as necessary
- Good Documentation Practices (procedures and instructions are written in clear, unambiguous language)
- Training for operators to carry out and document procedures
- Maintaining records that demonstrate that all the steps required by GDP were in fact taken and the quality and quantity were as expected. Any deviation is investigated and documented.
- Records of manufacturing and distribution that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form
- Distribution does not pose any risk to comprise the quality of the product
- System and protocol for recalling any batch from sale or supply
- Any complaint is examined, the causes of defects investigated, and appropriate measures are taken to prevent recurrence
CGMP is crucial to market balance and consumers’ confidence in pharmaceutical products. Without these practices, the pharmaceutical landscape would be a proverbial free-for-all. The negligence in good manufacturing practices seems to revolve around efforts to keep costs down. But the truth of the matter is that any attempt to circumvent CGMP results in astounding liability.
In 2012, a meningitis outbreak that caused 64 deaths was traced back to contaminated steroids produced at New England Compounding Center in Framingham, Massachusetts. Two senior officers of the company were charged with a range of crimes, including second-degree murder. Other employees were charged with lesser counts for their roles in the tragedy. The other charges include mail fraud, racketeering, conspiracy, structuring, and violations of the Food, Drug and Cosmetic Act.
The FDA requires companies to verify the accuracy of their labels and that the products are safe. The CGMP requirements were established to be flexible so that each manufacturer has the flexibility to decide how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. It is important that drugs are manufactured under conditions and practices required by the CGMP regulations to assure that quality is built into the design and manufacturing process at every step. Facilities that are in good condition, equipment that is properly maintained and calibrated, employees who are qualified and fully trained, and processes that are reliable and reproducible, are a few examples of how CGMP requirements help to assure the safety and efficacy of drug products.
The Specialty Operations Solutions group of WorkingBuildings provides turnkey solutions in the programing, quality assurance, construction quality control, validation, regulatory compliance and operations of medically regulated manufacturing facilities operating under the approval of the US Food and Drug Administration and European Medicines Agency.