GMP COMPLIANCE : Do you know the difference between OOS, OOE, | Pharma Q.

GMP COMPLIANCE : Do you know the difference between OOS, OOE, OOT…OOX results and how to manage them?


The main objective of the #pharmaceutical industry when manufacturing and testing #activeingredients, #excipients and m #medicinalproducts is to guarantee the quality and safety of the product and thus the safety of the patient.

The introduction of the Good Manufacturing Practice ( #GMP) guidelines for the #production, #testing, #storage, #transportation and #distribution of medicinal products established an internationally recognised quality standard for meeting this objective. The GMP guidelines are now part of national and supra-national laws and guidelines.

A GMP-compliant and proper handling of results that are outside defined criteria ( #OOXresults) indicates the level of GMP understanding among the personnel/entities dealing with the situation.
For this reason, regulatory inspections have a tendency to focus on this issue.

Despite the brisance that OOX results bring with them, a correct and confident handling of these types of result can be used during audits to demonstrate high quality standards. A structured approach to error analysis and data evaluation also provides very valuable information.

This information can then be used to improve the standard of quality.

Although the procedure was initially used for out-of-specification ( #OOS) results only, it was subsequently expanded as part of a growing awareness of quality to include results that deviate from expectations ( #OOE), trends ( #OOT), calibration values ( #OOC) and process parameters ( #OOL).
All of these considerations are used to identify specification non-compliance as early as possible and prevent an OOS case.

The OOX process also plays an important role during #methodtransfers, #validations and #outsourcing.
If the predefined responsibilities and documentation requirements are observed, the OOX process can also be carried out properly in an unproblematic way when third parties are involved.

All persons involved should undergo thorough training.