February 18, 2014
Pharmaceutical Industry Looks to Increase Compliance
Right now, FDA compliance is a major obstacle in the pharmaceutical industry. According to ExpertRECALL, in the third quarter of 2013, the FDA documented 171 drug and pharmaceutical recalls. Of these 171 recalls, sixteen were considered Class I, 124 were registered Class II and 31 were Class III.
To make matters worse, the number of units recalled in the third quarter was the second highest number of total units that were recalled in the last six quarters. Now, the FDA is continuing to discuss the proposed Pharmaceutical Quality, Security, and Accountability Act in order to create uniform policies for national prescription drug tracing.
One of the primary issues that contribute to FDA pharmaceutical recalls pertains to fill amounts. When producing drugs, manufacturers need to be able to ensure that the right fill amounts go into each pill or liquid. Each Active Pharmaceutical Ingredient must contain an exact, specified volume of drug portions in order to be effective for the user. Additionally, manufacturers must ensure that the inactive ingredients in a drug are of the right volume and consistency. This is especially crucial when administering drugs that must be injected or distributed over the skin. Creating inconsistent or inaccurate mixtures could lead to disastrous consequences when administering the drug if these ratios are off.
A Statistical Process Control platform is one regulatory system that can help enterprises ensure that when a drug is being manufactured, it contains all of the necessary parts for satisfying FDA compliance. InfinityQS ProFicient benchmarks quality measures with 21 CFR Part 11 compliance, which meets FDA standards for ensuring verified e-signatures for storing data electronically.
For more information about how InfinityQS ProFicient can streamline compliance checkpoints and help your pharmaceutical company stay in the FDA’s green zone, please click here.