University of Panama
Specialized Analysis Institute (IEA)
Official Notice No. IEA-002-2025
June 19, 2025
TO: All users of the Specialized Analysis Institute
FROM: Dr. GOY E. NAVAS T., IEA Director
SUBJECT: Quality Specifications for Finished Pharmaceutical Products
In compliance with the operational procedures of the IEA Quality Management System and in accordance with good laboratory practices, we inform you that, from this date forward, we will employ finished product specifications for quality control analyses for regulatory purposes as a valid technical document for the execution of analyses.
This decision responds to the need to ensure that all analyses conducted by the IEA are aligned with regulatory criteria and international standards, such as ICH, thereby ensuring the technical and legal validity of the results issued. Finished product specifications constitute the set of criteria that a pharmaceutical product must meet to guarantee its quality, safety, and efficacy in its final presentation. They are a central element in health registration and are designed to ensure that the product, once manufactured and in its commercial form, complies with the quality parameters established by regulatory authorities.
Release specifications correspond to the acceptance criteria applied by the manufacturer before releasing a production batch for distribution and commercialization, while shelf-life specifications define the requirements that must be met throughout the product’s validity period according to stability studies. Although these shelf-life specifications are useful in production and product monitoring, they are not valid under IEA regulations for official analyses as a reference laboratory for medicines before and after commercialization.
Therefore, we reiterate that all requests for quality control analyses must include only the current and approved finished product specifications, clearly indicating the parameters to be evaluated, the applicable analytical methods, and the acceptance limits established for the product in its final commercial form.
This measure is implemented because it has been observed that many clients submit only shelf-life specifications, or simultaneously release specifications and shelf-life specifications. This practice has caused confusion and misinterpretations in identifying the applicable criteria for different tests. By standardizing the submission of only finished product specifications, we aim to avoid ambiguities, ensure the correct interpretation of analytical parameters, and guarantee that the results issued correspond to the applicable requirements or regulations.
We appreciate your understanding and cooperation in applying this provision, whose objective is to ensure the quality and technical consistency of the services provided and to comply with the current regulatory framework.
“Quality and Competence in the Service of the Community”
2025: “Commemorating the 90th Anniversary of the University of Panama”
University City Octavio Méndez Pereira – University Mail
Panama City, Republic of Panama
Tel: 523-6264 / 523-6256
Email: goy.navast@up.ac.pa
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