A Comprehensive Pharmaceutical Stability Testing Laboratory II : Record and Control System Employed for the Laboratory

A description of a comprehensive record and control system employed as an integral part of the stability laboratory is presented. This is intended to facilitate the recording of the numerous data that become available from the products undergoing stability testing and to provide an accurate system for sending of samples for analysis at the correct time intervals. Stability evaluation cards used to record data of a product undergoing stability testing are described. Different color cards are employed for different storage conditions. The information preprinted on the cards varies according to the type of dosage form. The labels to be placed on the products being stored are shown to be similar in color to that of the stability evaluation cards. The captions preprinted on them are discussed. A simple foolproof control method for sampling preparations at designated time intervals is demonstrated. Simplified analysis report forms to be employed when samples are sent to the other groups for testing are illustrated and discussed. In order to have available a graphic icture of the progress for the various dosage forms being tested, the use of a visual low chart is described.