Laboratory testing is the soul of the successful operation by a drug maker. It is required as part of current Good Manufacturing Practices (cGMP) regulations to confirm that all the elements that go into a laboratory product, namely raw materials; in-process materials, finished materials, and containers conform to set specifications. When a laboratory test throws up an Out of Specification (OOS), how do laboratories deal with it?
The FDA takes a very serious view of Out of Specification results
The FDA is very stern in dealing with laboratories which come up with Out of Specification results. It inspects laboratory operations very closely, and has clear guidance on how the laboratory investigates Out of Specification and Out-of-Tolerance observation investigations.
cGMP regulation Sec 211.165 specifies that finished Out of Specification products which fail to conform to set specifications, safety standards and other quality standards will be rejected. These cGMP regulations also state that any unexplained deviation from the set specifications of a batch or its contents will be thoroughly investigated if its test results show an Out of Specification result. This is the same rule for both batches that have been distributed into the market, and those that are not.
Steps to deal with Out of Specification results
cGMP regulation makes Out of Specification testing compulsory for the release of a test batch. Whenever an Out of Specification result is confirmed, the batch gets rejected, and if there is ambiguity in the result, then the company’s Quality Assurance (QA) will have to state the reasons for the release and justify it.
Section 501(a) 2 (b) of cGMP guidelines on Out of Specification requires that current Good Manufacturing Practices need to go into the manufacture of both active pharmaceutical ingredient and finished pharmaceuticals. Further, active pharmaceutical ingredients, raw material testing, in-process and stability testing and Process Validation all come under the purview of the cGMP guidelines.
The FDA guidance on Out of Specification covers the following products:
o Human drugs
o Biology and biotechnological products
o Combination products
o Veterinary drugs
o Type A medicated articles
o Transplantation of human tissues
o Medicated feed
o Finished products & active pharmaceutical ingredients
o Dietary supplements
Need for understanding Out of Specification
All the complexity and depth of the issues relating to Out of Specification results need to be fully understood if a laboratory has to meet the required results. Important personnel in laboratories should have complete knowledge of the FDA expectations for Out of Specification results.
They have to use this knowledge to put in place procedures that define a complete, scientifically sound investigation of each Out of Specification and Out-of-Trend laboratory observation and to establish evidence that laboratory personnel are following the procedures.
A complete understanding of Out of Specification results and dealing with them
This will be the content of a training session that is being organized by Compliance4All, a highly popular provider of cost-effective professional trainings for all the areas of regulatory compliance.
At this session, Jerry Lanese, an independent consultant who focuses on Quality Systems and the components of an effective Quality System, will be the speaker. To understand the concept and workings of Out of Specification results and the ways of dealing with them, register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501214?Wordpress-SEO
Tools that help deal with Out of Specification results
At this webinar, Jerry will help participants build the foundation for the implementation of adequate procedures that help avoid Out of Specification results, and will review existing procedures and practices. This webinar is aimed at helping participants develop an understanding of the steps a compliant laboratory needs to take to handle the investigation of Out of Specification test results.
Jerry will also explain the ways in which the laboratory has to interface with other units through the laboratory investigation process. The FDA guidance on handling OOS laboratory results will be the foundation for this webinar, which will offer a clear process for compliant laboratory Out of Specification investigations.
Jerry will cover the following areas at this webinar:
o Why the regulators are concerned about the handling of OOS investigations
o The FDA model for handling OOS investigations
o Commonly accepted terminology such as repeat testing and retesting
o How the laboratory can meet regulatory expectations for OOS investigations.
o The interaction between the laboratory and other units in the organization.