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Analytical documentation development

Arctium lappa L. (burdock) is used as food, preventive and medical remedy. East medicine usually uses it as a fresh root of its first year of vegetation. In some countries burdock is cultivated for use as food and a medicinal herb. Thus the development of analytical documentation for this plant raw material is essential. [Pg.372]

D) Hazardous Waste Emissions The Commission requests the Committee include a review of EPA s June 1998 document. Development of a Hazardous Waste Incinerator Target Analyte List of Products of Incomplete Combustion, which concluded that current sampling methods for characterizing hazardous waste incinerator emissions provide an incomplete picture of the emission profile, and that a large number of products of incomplete combustion (PICs) remain unidentified therefore the health effects of these compounds are unknown. [Pg.110]

TABLE I Analytical Documentation Key Product-Specific Documents during Development... [Pg.503]

Analytical documentation during phase 2 includes IND amendments and internal development reports ... [Pg.507]

The standard operating procedure (SOP) manual contains the procedures validated by the laboratory it is a complete set of instructions for pre-analytical, analytical and post-analytical methodology and also procedures for quality assurance/control, chain-of-custody and security. Each step in the handling of the specimen should be evaluated, optimized where possible and documented in the SOP. Important steps in the analytical process include collection, transport and accessioning of the specimen, sample preparation, isolation and detection of the analytes, production of the report and disposal of the specimen. This chapter focuses on the quality assurance and control issues for analytical method development and validation as well as statistical representation of the data. [Pg.5]

Validation today is a key issue, and we may ask whether the work we do in formulating and developing a process has anything to do with industrial validation. The validation of a formulation or process, or for that matter, an apparatus or analytical method, is the demonstration (documented) that it behaves as it is intended to. It is therefore logical to conclude that if the documented development work (including that carried out using statistical design) supports the process and formulation, it must be considered a part of validation. [Pg.299]

Method Transfer. Method transfer involves the implementation of a method developed at another laboratory. Typically the method is prepared in an analytical R D department and then transferred to quahty control at the plant. Method transfer demonstrates that the test method, as mn at the plant, provides results equivalent to that reported in R D. A vaUdated method containing documentation eases the transfer process by providing the recipient lab with detailed method instmctions, accuracy and precision, limits of detection, quantitation, and linearity. [Pg.369]

There ar e many documents of biographic char acter in firnd the certificate of the professor, the diploma, materials about A.K. Babko s participation in conferences, symposiums, in lUPAC photos of the scientist during the various periods of a life correspondence with lar ge scientists of the world concer ning development of analytical chemistry as a whole, and in Ukraine. [Pg.406]

Some internationally harmonized guidelines regarding specifications and tests, impurities and validation of analytical methods have particular relevance to the development of chiral drugs and are discussed below. In addition, the impact of work on the common technical document is considered. [Pg.333]

Hi) Specialized Analytical Methods. Analytical methods for metallic impurities are well documented and are not covered here. A major advance in the continuous monitoring of impurities in liquid sodium down to the lowest levels of detection has been the development of analysis using electrochemical cells. Oxygen analysis in sodium may be carried out using a cell of the type... [Pg.337]

Product specification documents and analytical test methods—In preclinical development, these are important documents and they evolve along with the development phases. Drug substances and products for clinical trials are tested based on these documents, and so are the stability samples. It is critical to ensure that the analyst will perform the right tests against the right specifications with the correct version of the test method. Therefore a mechanism must be in place to control these documents. This can be done manually or with TIMS. A manually controlled system would require the analyst to sign out hard copies of the documents from a central location. After the testing is done, the analyst would have to return these controlled documents to the... [Pg.62]

For analytical methods used for generating data required in the field of residue behavior, environmental fate, and other fields, the guidance document SANCO/3029/99 rev. 4 was developed."... [Pg.20]

Reliable residue data are generated during the development of an a.i. to support the assessment of the consumer risk (residue data and toxicological data) and the impact on the environment (fate and behavior, efficacy and ecotoxicological data). It is critical that these analytical methods are reliably validated. In the guidance document SANCO/3029/99 rev. 4 (11/07/00), harmonized requirements for the residue analytical method are described. Validated analytical methods are required for the following studies ... [Pg.32]

Until 1991, manufacturers seeking authorizations for pesticides had to fulfil country-specific requirements of validation of enforcement methods. The term enforcement method means analytical methods which are developed for post-registration control and monitoring purposes. The harmonization of these requirements was initiated with the European Economic Community (EEC) Council Directive 91/414/EEC and temporarily finalized with the Guidance Document on Residue Analytical Methods SANCO/825/00 rev. 6, dated 20 June 2000 [Santd et Protection des Consommateurs (SANCO)]. The evaluation of validation studies by the competent authority is conducted by comparison of these European Union (EU) requirements with the study results and most often without any practical experience of the method. Some details of this evaluation are discussed below. [Pg.96]


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