Testing is a critical process in the pharmaceutical industry to verify the authenticity, presence or absence of certain components, pass or fail and determine quality of a given sample. The tests samples consists of different types, such as final finished product , packaging and raw materials. It helps determine whether the process or product fulfils its intended function or not. The main part of testing is acceptance criteria, which sets a clear boundary between passed and failed results.
Acceptance Criteria in the pharmaceutical industry is a critical parameter that represents the success or failure of any process, product, or system. Any test result that does not fulfil the acceptance criteria is called Out of Specification. Unlike other industries, the failed results are further investigated to rectify the fault and determine the root cause. The main idea behind this is to improve product quality, prevent occurrence of problems and save the market reputation of the pharmaceutical product manufacturer.
Out-of-specification test results are also regulated by the United States Food and Drug Administration (FDA), and describe methods to identify and investigate them. The main advantage of FDA guidelines is to provide guidance to industries in solving issues, and focus on implementing improvements to their processes rather than inventing new procedures.
What are Out-of-Specification (OOS) Test Results
Out of Specification (OOS) test results refer to those that fall outside the acceptance criteria as defined in the drug application, drug master file, or as specified by the manufacturer. The scope of OOS results includes finished products, in-process materials, laboratory testing, and raw materials.
The OOS test results indicate problems with the process, individual components, raw materials, and other related elements, and these must be investigated. These are the first indications of the problems, and by carefully and strategically addressing these issues, pharmaceutical product manufacturers can decrease the chances of recalls and increase the likelihood of a quality reputation for their drugs in the market. In addition to product effectiveness, it also represents the established practices, facilities, and preparedness of the product manufacturer for implementing quality and solving safety related issues.
United States FDA guidance for Out of Specification Test
The United States FDA has published its guideline for OOS, titled "Investigating Out-of-ofSpecification (OOS) Test Results for Pharmaceutical Production Guidance for Industry". In it, the US FDA provides its thinking on how to evaluate OOS test results, covering chemistry-based laboratory testing of CDER-regulated drugs. This guidance applies to tests performed on Active Pharmaceutical Ingredients (API), excipients, in-process materials, and finished drug products.
This guidance can also be used for in-house testing of different components of the drug. Additionally, any firms involved in testing laboratories or production are also responsible for following these guidelines.
Investigating OOS Test in light of FDA Guidance
Whenever there are OOS tests, it is necessary to investigate the source. Because it could be a deviation in the approved manufacturing process or the problem with the measurement device. If a batch is rejected based on OOS results, the relationship determines whether other batches or products are involved. The investigations must be in written form with detailed procedures, conclusions and follow-up.
For an effective outcome, the investigation should be based on scientific procedures, unbiased, timely, and well-documented. In the first phase, personnel should assess the accuracy of laboratory data related to the OOS tests, which must be performed before test preparations.
Suppose the test is related to the CDMO. In that case,...
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