{"id":19118,"date":"2026-06-16T18:53:18","date_gmt":"2026-06-16T11:53:18","guid":{"rendered":"https:\/\/www.tibdglobal.com\/product\/shelf-life\/"},"modified":"2026-10-06T13:35:14","modified_gmt":"2026-10-06T06:35:14","slug":"shelf-life","status":"publish","type":"product","link":"https:\/\/www.tibdglobal.com\/en\/product\/shelf-life\/","title":{"rendered":"Shelf Life Determination Service from Stability Testing Data"},"content":{"rendered":"
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Many operators in Thailand’s health and beauty industry set product expiry dates by reference to competitors or default to 24 months as commonly seen in the market, without empirical test data to support the claim. The consequences are documentation rejected by the Food and Drug Administration (FDA) during registration, international importers declining purchase orders, or product recalls when active compounds fall below the label-stated quantity before the announced expiry date.<\/p>\r\n

The cost of a Shelf Life Determination study is significantly lower than the cost of a product recall, consumer compensation, formula reformulation, or lost export market opportunities. Stability Data is the tool that transforms “estimated shelf life” into “data-backed shelf life determination,” which is the international standard under ICH Q1A(R2) and the ASEAN Stability Guideline for ASEAN Zone IVb (30\u00b0C \/ 75% RH).<\/p>\r\n

TIBD’s service covers stability protocol design, sample storage management under defined conditions, statistical data analysis per ICH Q1E, and data interpretation in partnership with VISBIO as an Independent Quality Assurance Verifier (IQAV) using Validated Methods per ICH Q2(R1), to produce a shelf life report that can be used for Thai FDA registration, for negotiating with international importers, and for product labeling.<\/p>\r\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column]\n\t\t

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<\/span>What is Shelf Life? Definition and Importance for Health and Beauty Products<\/span><\/h4>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t\t\n\t\t[vc_column_text css=”” woodmart_inline=”no” text_larger=”no”]\r\n

Shelf Life is the period during which a product maintains the quality, safety, and efficacy stated by the manufacturer, when stored under normal conditions as specified on the label. Under the ICH Q1A(R2) definition, shelf life is the period during which the key attributes of a product, physical, chemical, microbiological, and pharmaceutical efficacy, remain within the Specification stated in the registration documents.<\/p>\r\n

The importance of shelf life has three primary dimensions. The first is consumer safety: expired products may generate degradation products or microbial contamination that could be harmful. The second is regulatory registration: the Thai FDA, Indonesia’s BPOM, Malaysia’s NPRA, Singapore’s HSA, and Vietnam’s DAV all require stability data based on ICH Q1A(R2) and the ASEAN Stability Guideline before approval. The third is commercial credibility: international importers, retailers, and pharmacies use shelf life as a condition for purchasing products.<\/p>\r\n

Products without shelf life data based on actual testing have a high probability of being rejected at the documentation stage, or must accept a disadvantage in price negotiations because buyers need to manage the additional risk themselves.<\/p>\r\n[\/vc_column_text][vc_single_image image=”18937″ img_size=”full” alignment=”center” css=”” parallax_scroll=”no” woodmart_inline=”no”][\/vc_column][\/vc_row][vc_row][vc_column]\n\t\t

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<\/span>Differences between Expiry Date, Best Before, Use By Date, and Period After Opening (PAO)<\/span><\/h4>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t\t\n\t\t[vc_column_text css=”” woodmart_inline=”no” text_larger=”no”]\r\n

Operators often confuse these terms. Using the wrong term on the label can result in registration documents being rejected or consumers being misled.<\/p>\r\n\r\n