Good GMP Labeling
An summary of good industrial practices, directed at those interested with research and development, is important for the late-stage production phase of any sensitive material planned for use with an in vitro testing, medicinal, medical device, or any of a whole host of other applications controlled by the United States. Food and Drug Administration (FDA), read this article.
While most of the Code of Federal Regulations (CFR) and the Points to Consider provide guidance for the finished diagnostic kit (or finished pharmaceutical, etc.), in the latter stage of research and development, detailed record-keeping and other practices are needed to comply with the increasingly stringent regulations on historical development information and traceability to the sou
This document is not meant to be a comprehensive discussion of the requirements, but rather to highlight those practices necessary to ensure that, on an ongoing basis, the level of control and record-keeping required for licensing such products begins during the critical materials research phase.
System and development checks ought to be in operation. Such checks help to prevent any mistakes that might harm the quality of the company. Failure detection must be integrated into the manufacturing-supporting practices. A section of the GMPs is devoted to these controls and states: specifications and processing procedures must be in writing and must be checked in such a way that the product (or material) being produced conforms to its original design or any approved modifications to that design.
The first and most fundamental form of control is to record what is being done so that it can be read and understood well into the future. When correctly completed, reports will demonstrate just what was completed, where and by whom, if concerns occur.
This can not be overly emphasized that this is the foundation of any and all research being done, whether in favor of development or experimental study not controlled by the GMP. Every entry on a log, every page of a lab notebook, or any document used in production, should be dated and signed (or initialed), reviewed by a senior person who is knowledgeable about the subject matter and added his / her signature (and date). It means the research done is properly traceable and transparent.
If a record-keeping mistake happens, you will line up the error (with a single sheet), date and original the error, and then report the precise details. You must not erase the error by scratching it out, typing it over, or using (white-out) correction fluid.
While utilizing reagents, filters, materials that can touch the drug, and test kits to ensure operation, sterility, physical specifications, and other appropriate details to the sensitive content, it is important to report the manufacturer name, inventory number, lot number and expiry date, together with the sample design and outcomes of these tests. It enables the research done by third parties to be checked with certainty that the criteria remain under check and that the study can or has been repeated.
In no way is this paper meant to be a detailed overview of the safeguards that must be implemented during late-stage research and production of essential raw materials that will ultimately make their way into finished diagnostics, appliances, or pharmaceutical goods.
Rather, it is a starting point for understanding that regulatory requirements for control are being pushed further toward the research and development phase and further back up the “pipeline.” Consumer standards have been more strict, as the FDA has demanded that certain previous ties to production research remain in effect and under supervision before the completed product or medication is approved.