Stability Operating Procedures study

To determine the stability of the test and control articles in the mixture as required by the conditions of the study either (i) before study initiation, or (ii) concomitantly according to written standard operating procedures which provide for periodic analysis of the test and control articles in the mixture. 

Test system sanples which are relatively fragile and differ markedly in stability and quality during storage shall be retained only as long as necessary to insure the validity of the study. There shall be appropriate standard operating procedures for disposal of test system sanples. Sanples of test or control... 

Clinical trial supplies which include full QC and supporting stability studies to show that product-pack is satisfactory for issue (i.e. IND stage in the USA). See also (8) below, paying usual attention to GMP, effectiveness of standard operation procedures (SOPs), etc. 

Every company must have a written stability program documented in a standard operating procedure (SOP). This program will define the requirements for stability studies to be put up to assess the stability profile and the expiry of the drug product. It is required to have the sample sizes and testing intervals defined along with storage... 

This chapter introduces day-to-day activities necessary to a successful stability program. It explains critical activities as well as most common practices to manage stability studies from the time that samples are delivered to the stability laboratories to the time that study ends. These activities are usually written into Standard Operating Procedures (SOPs). Many companies have a dedicated group of analysts to manage these operations. 

The data required for a kinetic formulation of the deactivation of the main reaction are probably best collected in a differential reactor. Some extrapolation to zero time is required when the reaction rate of the main reaction cannot be observed at zero coke content. The procedure can be hazardous with very fast coking, of course. In their study of butene dehydrogenation, Dumez and Froment [1976] were able to take samples of the exit stream of stabilized operation of the fixed bed reactor after 2 minutes, while the observations extended over more than 30 minutes. 

The objective of the present study is to develop a cross-flow filtration module operated under low transmembrane pressure drop that can result in high permeate flux, and also to demonstrate the efficient use of such a module to continuously separate wax from ultrafine iron catalyst particles from simulated FTS catalyst/ wax slurry products from an SBCR pilot plant unit. An important goal of this research was to monitor and record cross-flow flux measurements over a longterm time-on-stream (TOS) period (500+ h). Two types (active and passive) of permeate flux maintenance procedures were developed and tested during this study. Depending on the efficiency of different flux maintenance or filter media cleaning procedures employed over the long-term test to stabilize the flux over time, the most efficient procedure can be selected for further development and cost optimization. The effect of mono-olefins and aliphatic alcohols on permeate flux and on the efficiency of the filter membrane for catalyst/wax separation was also studied. 

Development studies, summarized within a distinct report on the physiochemical aspects, drug substance attributes, and finished product characteristics, become critical parts of the validation package. Such data is also valuable for future integration into a manufacturing operation. This includes the scientific rationale for formulating and bulk-handling procedures, lyophilization processing parameters, finished product analysis, and stability requirements. 

Our research in this field, which is summarised in this chapter, has been directed at obtaining a sensor modified with PB as electrochemical mediator which could avoid electrochemical interferences and could also couple the advantages of the screen-printed electrodes. For this purpose, an in-depth study of the modification procedure for PB deposition on the electrode surface was first conducted and then when an optimised procedure capable of providing an efficient and stable PB layer was obtained, it was applied with screen-printed electrodes in real analytical systems. Thus, our main goal has been not only to obtain a PB modification procedure suitable for a mass production of modified screen-printed electrodes, as already pointed out above, but also to achieve a stable PB layer in terms of operative and storage stability. 

Nuclear reactions producing exotic nuclei at the limits of stability are usually very non-specific. For the fast and efficient removal of typically several tens of interfering elements with several hundreds of isotopes from the nuclides selected for study mainly mass separation [Han 79, Rav 79] and rapid chemical procedures [Her 82] are applied. The use of conventional mass separators is limited to elements for which suitable ion sources are available. There exists a number of elements, such as niobium, the noble metals etc., which create problems in mass separation due to restrictions in the diffusion-, evaporation- or ionization process. Such limitations do not exist for chemical methods. Although rapid off-line chemical methods are still valuable for some applications, continuously operated chemical procedures have been advanced recently since they deliver a steady source of activity needed for measurements with low counting efficiencies and for studies of rare decay modes. The present paper presents several examples for such techniques and reports briefly actual applications of these methods for the study of exotic nuclei. 

Failure to establish yields or acceptable levels of rejects for both in-process and finished product Failure to conduct stability studies Manufacturing equipment not identified and/or qualified Inadequate training of employees working in aseptic operations Inadequate process change procedures Validation protocols that lack acceptance criteria Incomplete investigations of laboratory failures Failure to follow United States Pharmacopeia (USP) procedures for the bacterial endotoxin test... 

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