Stability Operating Procedures standard

Hazardous Materials Response Team An organized group of trained response personnel operating under an emergency response plan and appropriate standard operating procedures, who are expected to perform work to handle and control actual or potential leaks or spills of hazardous materials requiring close approach to the material to control or stabilize an incident. 

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. 

Thermal stability. A manual, semiautomatic or automatic CFR fuel coker shall be used. The equipment and operating procedures shall be in strict accordance with Method 3464 of Federal Test Method Standard No 791. No deviation from this method is aUowed... 

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... 

To determine the stability and, when relevant to the conduct of the experiment, the solubility of the test, control, or reference substance in the mixture before the experimental start date. Determination of the stability and solubility of the test, control, or reference substance in the mixture shall be done under the environmental conditions specified in the protocol and as required by the conditions of the experiment. Where periodic analysis of the mixture is required by the protocol, there shall be written standard operating procedures that shall be followed. 

Each immunoassay must have a standard operating procedure (SOP). The SOP must address the entire analytical procedure (i.e., extraction, cleanup, detection, and data analysis and interpretation). Reagent stability and procedural precautions must also be included in the SOP. 

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. 

In the final operating procedure adopted for preparation of liquid Diazyme L30, the mycelium was removed on the vacuum precoat filter, the calculated amount of sodium benzoate to give 0.1% in the final product was added to the filtrate, it was evaporated under vacuum, standardized to 30 DU/ml. potency, and drummed for shipment. Stability assay data for ten different commercial batches are shown in Table VIII. 

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... 

The trend identification can be qualitative and performed by graphing the stability data or could be performed by statistical analysis of the collated data. In both cases, the site OOT Standard Operating Procedure (SOP) defines criteria for designating a data deviation from the norm as an OOT incident. The OOT criteria must be set in such a way that all significant OOT incidences are identified, ideally without false positives. 

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. 

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