Reference standards storage

To test further this hypothesis, a simulated cell/tissue model system has been devised using quantitatively comparable cell fines, in which the amount of selected antigen (potential reference standard) can be measured accurately on a cell-to-cell basis in fresh and FFPE specimens that are processed under clearly defined but variable conditions, including periods of formalin fixation, delay times of fixation (prefixation time or warm ischemic time), storage conditions, and other technical issues such as thickness of each tissue section, in... 

Hodgson DW, J.F. Thompson, Watts, RR. 1982. Accuracy of pesticide reference standard solutions. Part II Chemical stability under four storage conditions. J Assoc Off Anal Chem 65 94-102. 

Equipment Maintenance/Calibration/Monitoring Method Validation Standard/Reference Material Storage of Labile Components Laboratory SOPs Testing Quality Identity... 

The laboratory shall have procedures for safe handling, transport, storage and ttse of reference standards and reference materials in order to prevent contamination or deterioration and in order to protect their integrity. 

As it is imperative that the plant-derived hiopharmaceutical product must be obtained repeatedly and on a consistent basis, a master cell culture bank, seed bank for transgenic plants, or virus seed stock for transient expression systems must be constantly maintained. Storage conditions must therefore he optimized to prevent contamination and ensure viability. Both transgene stability (e.g., reversion to wild type or sequence drift of plant virus expression vectors) and protein expression levels must be monitored in a representative plant of a given bank or stock to minimize any possible variation in expression levels that may affect safety and consistency of the hnal product. A program that monitors lot-to-lot consistency of the hiochemical and biological properties by comparing the product with appropriate in-house reference standards could he implemented as a fundamental component of product development. 

A modem monograph is devoted to a drug substance and starts with a concise description of the product. This is followed by instructions for packaging and storage, relevant USP reference standards, identification, and procedures for the assay of the drag or the product components. There is sufficient information for those skilled in the arts to be able to analyze the drug and its components, making the compendium... 

Reference standards must be characterized as to purity, batch or lot nuntoer, source, storage requirements, and traceability, and... 

Maintenance records of reference standards, stock standard solutions, and working standards are not complete, and a method of handling these standards is not properly documented. Storage of stock and working standards, labeling of all standards, and a plan for disposal are not well defined. 

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. 

Reference standards are labeled such that their identity, potency, correct use, and correct storage can be assured at all times. Reference standard labeling must also ensure that laboratory personnel handling the material are properly informed of safety risks associated with potentially harmful chemicals. 

Sample tracking and storage Reference standard control... 

Standard/Reference Material Storage of Labile Components Laboratory SOPs... 

A pure, stable, and well-characterized reference standard is a vital component of a validated PK assay. When accompanied by appropriate sample collection and storage procedures, such a validated assay is the only means to accurate quantitation of protein therapeutics in biological samples. 

Reference Standard and Critical Reagents Source records should document lot numbers, date of receipt or preparation (as appropriate), the identity, purity, and stability at the time of use, expiration date (as applicable), storage location (e.g., equipment identifiers), and temperature conditions. 

A reference standard should be developed and appropriately quahfied for defined physico-chemical characteristics, specificity, and potency [34, 35]. Storage under conditions that maximize stability (e.g., -80 °C as appropriate) and periodic testing will document the reference standard s continued physico-chemical integrity and justify its continued use. The reference standard should be used for lot-to-lot comparisons performed for product release and stability studies [34, 35]. Major manufacturing changes often warrant estabhshment and qualification of new reference standards. 

Control laboratories should be designed to suit the operations to be carried out in them. Suffident space should be given to avoid mix-ups and cross-contamination. There should be adequate suitable storage space for samples, reference standards (if necessary, with cooling), and records. 

For reference standards, the label or accompanying document should indicate concentration, date of manufacture, expiry date, date the dosure is first opened, and storage conditions, where appropriate. 

Where necessary, the date of receipt of any substance used fortesting operations (e.g., reagents and reference standards) should be indicated on the container. Instructions for use and storage should be followed. In certain cases it may be necessary to carry out an identification test and/or other testing of reagent materials upon receipt or before use. 

The label of reference standard should indicate the concentration, date of manufacture, expiration date, date the close is first opened and storage conditions where appropriate. 

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