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the various time points during accelerated stability study and at intermediate storage conditions when they are used and evaluation of long-term stability data Different scenarios for retest period and shelf life determination are presented based on the results observed under accelerated, intermediate, and long-term storage conditions [11], as described below Long-Term and Accelerated Stability Data Show Little or No Change over Time and Little or No Variability The drug substance or drug product can be considered stable if the long-term and accelerated stability data show little or no change or little no variability over time In this scenario, no statistical analysis is required but a justi cation should include a discussion of the pattern of change or variability or lack of change or variability, supportive accelerated stability data, mass balance of drug substance in samples, and/or other supporting data.

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The retest period or shelf life in this scenario can be up to twice as long as but not more than 12 months beyond the period covered by long-term storage stability data However, extrapolation of the retest period or shelf life beyond the period covered by long-term data can be proposed Long-Term and Accelerated Stability Data Show Change over Time and/or Variability In this scenario, statistical analysis of the long-term data can be useful in establishing a retest period or shelf life When there are differences, for example, among batches or among dosage strengths, container sizes, and/or ll or any combination thereof that preclude combining the data, the proposed retest date or shelf life should not exceed the shortest period supported by long-term studies of any batch, other factors, or combinations of factors.

The cGMP regulations are written to address the primary potential sources of product variability. Subpart B establishes the quality control unit and the duties of that unit, establishes personnel requirements and addresses personnel practices (e.g. sanitation) intended to reduce the likelihood of product contamination. Subparts C and D establish requirements for buildings and facilities and equipment used in the manufacture, processing, packing, or holding of a drug product. Subparts E through H establish controls over the major processes associated with the production of a nished and packaged drug product that is ready to be shipped for distribution to users. Controls are established for incoming raw materials and components and continue through manufacturing, packaging, labeling, holding, and distribution of nished, packaged, labeled, and released drug product. Subpart I requires the establishment of scienti cally sound and appropriate speci cations, standards, sampling plans, and test procedures; requires instrument speci cations and calibration; and establishes lot or batch testing and release requirements. Subpart J establishes documentation requirements including master and batch records, and Subpart K addresses the control and disposition of returned drug products and places limitations on the salvage of drug products that have been subjected to improper storage conditions (e.g., smoke, heat, re, moisture). 3.2.1.1 Duties of Quality Control Unit under cGMP Regulations

In t h i s section, properties of the weighted linear least squares estimator (5.242)are presented in the form of theorems.

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