Final package validation

Shelf-life estimation involves developing a thermodynamic model of the dry reagent chemistry. This model is used to make projections of the shelf-life and the estimates are continuously compared with real time data to substantiate the validity of the model or to revise it. A typical study to create a database for shelf-life estimation may consist of subjecting a dry reagent chemistry, in its final packaging format, to continuous thermal stress for 2-3 years in the temperature range of 0-70 °C. An example of a schedule for such a study is shown in Fig. la. At each check point, dry reagent chemistries are removed from each of the stress conditions, allowed to come to thermal equilibrium, and analyzed, and the per-... 

FINAL SYSTEM VALIDATION APPROVAL The signatories below have reviewed the validation package for the [name of the supplier (vendor), and name of system] computer system. The review included the assessment of the phase reports listed below, including details of the execution of approved test scripts, test phase conclusions based on test phase acceptance criteria, and resolution of items listed in issues log. The determined validated status is derived as a culmination of this review process. ... 

Enhanced turn-over package Installation qualification protocols Operational qualification protocols Change control initiation Cycle development Performance qualification protocol Process validation protocols Validation final reports Validation package Certificate for use in manufacturing Required protocols and procedures for dry production Required protocols and procedures for liquid and semisolid products... 

ISO 11607 addr ses the package system validation in three phases, or clauses. Clause 4 specifies the basic attributes required for a wide range of materials as they combine and interact with various medical devices, packaging designs, sterilization methods, and distribution modes. Clause 5 defiites the framework of activities to qualify the processes used to make and assemble the final package... 

Homogeneity. Homogeneity assures that the analysis of all subsamples of the reference material taken for measurement will produce the same analytical result within the stated measurement uncertainty. This is particularly important in the case of certified reference materials. Reference material producers therefore must specify the minimum amount of sample for which homogeneity has been measured and is valid. Finally, the ease of re-homogenizing the material after packaging must be taken into consideration. 

A number of computer software packages are available to the analyst to assist in the planning and execution of both method development and validation experiments. The attraction of these systems is that they can automate the validation process from planning the experiment to test execution to the presentation of the data in a final report form. 

The aim of validation is not to correct or detect deviations in the packed product but to prevent deviations in the final packed products as far as is practicable and economic. The whole package in all its aspects must be considered from its manufacture throughout packaging of the drug substance to delivery to the patient and beyond (for environmental reasons). Some of the areas associated with packaging are listed in Table 1. 

The OQ final report is intended to summarize all relevant data that are collected during the validation run. The report gives a short description of all test functions and a discussion of the overall validation. This compilation is adequate documentation of assurance of the acceptability and validity of the packaging equipment. The basis for this assurance is the result of the data, test functions, and supporting documentation. A dossier in sections is provided in Table 5. 

After the design and manufacturing phases of the package, the final validation may be performed on actual-production scale batches. 

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