Batch-certification

Identification of dyes on dyed textiles is traditionally carried out by destructive techniques [493], TLC is an outstanding technique for identification of extracted dyestuffs and examination of inks. Figure 4.9 shows HPTLC/SERRS analysis of acridine orange [492], Wright et al. [494] have described a simple and rapid TLC-videodensitometric method for in situ quantification of lower halogenated subsidiary colours (LHSC) in multiple dye samples. The results obtained by this method were compared with those obtained by an indirect TLC-spectrophotometric method and those from HPLC. The total time for the TLC-videodensitometric assay of five standards and four samples applied to each plate was less than 45 min. The method is applicable for use in routine batch-certification analysis. Loger et al. [495,496] have chromatographed 19 basic dyes for PAN fibres on alumina on thin-layer with ethanol-water (5 2) and another 11 dyes on silica gel G with pyridine-water... 

A MRA on standards and conformity assessment between Australia and the EC came into effect from 1999, covering eight industry sectors including GMP inspection and batch certification of medicinal products, and conformity assessment of medical devices. 

Annex A Internationally Harmonized Requirements for Batch Certification... 

The final cost and time saving to be discussed is the batch certification provision. The important aspect of this provision is that FDA, not industry as in the past, will now be responsible for certifying the quality of batches of such drugs as antibiotics. Hence, given that FDA would be paying the bill and would be responsible in part for an adequate supply of drugs such as antibiotics, the certification process is expected to be timely. Furthermore, under this provision, companies can establish a certification record that will allow them to be exempted from this requirement—a time as well as cost savings. 

A similar agreement to the MRAs is the Protocol to the European Agreement on Conformity Assessment and Acceptance of Industrial Products (PEC A) made public by the EC in March 2002. It was prepared in order to facilitate the operation of the annex on GMP for medicinal products inspections and batch certification to such PECAS. The type of information that should be exchanged between the EU and associated countries and the obligations with respect to joint inspections and inspector training are also delineated. 

To be used or sold in the United States, this color additive must be batch certified by the U.S. Food and Drug Administration. The monograph title is the name of the color additive only after batch certification has been completed. 

FDA-certifiable color additives are batch certified by the United States Food and Drug Administration using analytical chemistry methods developed for this purpose by the FDA. The color additive regulations are described in Title 21, Parts 70 to 82, of the United States Code of Federal Regulations (21 CFR Parts 70 to 82). The batch certification process is described in 21 CFR Part 80. Current certification analytical methods are available from the Office of Cosmetics and Colors, Colors Certification Branch (HFS-107), U.S. Food and Drug Administration, 5100 Paint Branch Parkway, College Park, Maryland 20740. 

Factory cahbration certificates (full certificate or batch certificate of conformance)... 

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