Retest dates

Laboratory Controls General Controls Testing of Intermediates and APIs Validation of Analytical Procedures Certificate of Analysis Stability Monitoring of APIs Expiry and Retest Dating Reserve/Retention Samples Validation... 

For drug substances, a retest date is generally determined. The period up to the retest date is a period during which the material is known to adhere to its specification, for example, for assay or degradants. The retest date may be assigned on the basis of real-time stability data obtained at the recommended storage conditions or on the basis of accelerated stability data obtained under more stressful conditions. 

Labeling requirements in 58.105(c) are not controversial and are the minimum to ensure against mix-up of test or control articles. The Expiration date needs to be included on the label only if one has been established. Some laboratories include a retest date on the label as a reminder of the need for periodic stability analyses. Only special storage conditions (e.g., refrigerate, protect from light, protect from freezing ) need to be included on the label. 

To ensure safe and effective finished drug products, the excipients must be stable. Some excipients may be stable and may not require extensive testing, while others may be less stable and require more scrutiny. A retesting or expiration date should be identified on the container label and the COA of the raw material at the time of use. Expiration or retest dates should relate to any storage conditions stated on the label and should be supported by appropriate stability studies. 

Also stamped on the cylinder will be the retest dates. A cylinder must have a current (that is, within 5 or 10 years) test stamp. On the collar of the cylinder, the owner of the cylinder may be... 

Perhaps the most important criterion for registration stability studies (i.e., the studies used to determine the retest date for an API and the expirationdating period for a drug product) is the selection of batches, which must be representative of the material to be marketed. 

Solution stability is as expected (per expiration/retest dates). 

Pilot facility lab scale Preliminary data retest date Proscribed suppliers Varies according to protocol guide lines documented and adequately justified... 

If the intermediate or API is intended to be transferred outside the control of the manufacturer s material management system, the name and address of the manufacturer, quantity of contents and special transport conditions, and any special legal requirements should also be included on the label. For intermediates or APIs with an expiry date, the expiry date should be indicated on the label and certificate of analysis. For intermediates or APIs with a retest date, the retest date should be indicated on the label and/or certificate of analysis. 

Table 24. Minimum stability ( retest date ) of povidone stored in the original containers (max. 25°C, Ph.Eur. and USP requirements)...

All reference standards entering the laboratory are properly logged. Information typically logged is identification (compound number or name), lot number, storage conditions, retest date, and the analyst to whom the standard is assigned. 

Permanent records, written or electronic, should exist for each stored product indicating recommended storage conditions, any precautions to be observed and retest dates. Pharmacopoeial requirements and current national regulations concerning labels and containers should be respected at all times. 

All containers should be clearly labelled with at least the name of the material or product, the batch number, the expiry date or retest date, the specified storage conditions and reference to the relevant pharmacopoeia where applicable. Only authorized abbreviations, names or codes should be used. 

A reference standard must have documentation to support its use as a standard, establish its assigned assay, and defend the retest date (or expiry date for chemical standards). 

A retest period should be derived from the stability information, and a retest date should be displayed on the container label if appropriate (Table 7). 

When an intermediate is intended to be transferred outside the control of the manufacturer s material management system and an expiry or retest date is assigned, supporting stability information should be available (e.g., published data, test results). 

An API expiry or retest date should be based on an evaluation of data derived from stability studies. Common practice is to use a retest date, not an expiration date. 

Preliminary API expiry or retest dates can be based on pilot-scale batches if (z) the pilot batches employ a method of manufacture and procedure that simulates the final process to be used on a commercial manufacturing scale and (zz) the quality of the API represents the material to be made on a commercial scale. 

Retest date The date after which samples of the drug substance should be examined to ensure that the material is still in compliance with the specification and thus suitable for use in the manufacture of a given drug product. 

A summary, including tabular and graphic presentations of results, of the stability studies undertaken on a drug substance is to include information on testing conditions, batches, and analytical procedures and a discussion of the results and conclusions. Also to be included are the proposed storage conditions, retest dates, or shelf life (where relevant) and a summary of the postapproval stability protocol. 

Satisfactory retest results on a drug substance batch after the retest date do not mean that the retest period can be extended for that batch or any other batch. The purpose of retest is to qualify a specific batch of a drug substance... 

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