Out potential danger from impurities, instability, contamination,

Out of Specification (OOS) process is used to assess test result that falls outside the specified criteria, this includes abnormal, atypical, and irregular results. The OOS is there to see why the drug didn’t meet the specification; where did it went wrong; who is responsible, and who should tribute to the responsibility of laboratory personnel?


When a set of product data has substantial variants, it could end up not meeting the specified criteria, and when the experiment results are out of specification the drug batches need to be recalled and tested. This included component such as the active pharmaceutical ingredients (API), excipients, the finishing products as well as method and the validation status, mobile phase, standard accuracy and system suitability. A formal investigation is there to lead the investigator throughout using formal logical sense with analytical manor without lead by intuition. It is important to find out where it went wrong before repeating the analysis, otherwise it could end up with the same inaccurate result.

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However, OOS is not applied to every analytical result, it only applies to samples that are for human consumptions. World Health Organisation (WHO) defines OOS results as “All test results that fall outside the specifications or acceptance criteria established in product dossiers, drug master files, pharmacopoeias or by the manufacturer.” (WHO, 2017, p. 108) In order to archive quality product, pharmaceutical companies must follow the Good Practical Regulations (GXP) which included Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacture Practice (GMP) (World Health Organisation, 2014). The quality of the product needs to ensure the patients will not be put in risk of any potential danger from impurities, instability, contamination, etc. this also includes incorrect dosages of API as it could lead to serious health concerns including harmful side effects which could lead to death.


OOS investigation is formed by 3 phases in order to assess the data. Phase 1 is the initial investigation of trying to identify where the obvious issues are within the laboratory to phase 3 where the final decision is made if a batch gets rejected and an OOS investigation form and an analytical report are required. Everything must be documented, this acts as a corrective and a prevention plan to use as a record (UK Medical Devices Agency, 2013). It is important that OOS ensures events like this are less likely to occur again and the quality of the sample products are efficient, effective and purposeful.


Scientific methods are applied to develop a corrective and preventative action plan, it should have accountability for the process of the legal requirement. This could always be applied when comes to terms to fix the problem of an OOS result. If these OOS results are not dealt with properly, patient safety could be compromised. Because as patients they are incapable to detect if the drug products given are safe, therefore it is up to the manufactures to ensure their products are safe for human consumptions by meeting the required regulations as patient safety is the number 1 priority in the pharmaceutical industry (WHO, 2017). Companies will have quality assurance organisation that test raw material and intermediate used to create the drug, which also regulators the step of manufacturing, collect representative samples and put together a specification for the final product.