Good tissue practices

FDA resources are expended in areas based not on their absolute importance but on the lack of industry capability to control a particular concern. When manufacturing processes were primitive, unclean, and uncontrolled, the FDA issued the Good Manufacturing Practices and eventually the Good Laboratory Practices, Good Clinical Practices, and Good Tissue Practices. Together these Practices provide standards for the industry operations. 

Guidance for FDA Review Staff and Sponsors Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) (draft guidance) (November 2004) Current Good Tissue Practices for Human Cell, Tissue, and Cellular Tissue-Based Product Establishments Inspection and Enforcement (November 2004)... 

FDA implements Good Tissue Practice final rule www.fda.gov/Biolog- icsBloodVaccines/ TissueTissueProducts/ QuestionsaboutTissues/ ucml02994.htm... 

FDA Proposed Rule Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products Inspection and Enforcement (66 FR 1508 January 8,2001)... 

FDA Final Rule Current Good Tissue Practice for Human Cell, Tissue and Cellular Tissue-Based Product Establishments Inspection and Enforcement (69 FR 68612 November 24,2004)... 

Regulations now in effect compel the registration of sponsors and other persons engaged in production and distribution of such products, to screen donors of tissues used to produce HCT/Ps, and to observe Good Tissue Practices in their manufacturing or processing of such products. 

Dinitroaniline herbicides show minimal plant systematic translocation properties with the majority of the absorbed residues in the root tissues. Metabolites identified include traces of Al-dealkylation, alkyl and aryl hydroxylation and nitro reduction products. Low levels of dinitroaniline herbicide residues have been reported in raw agricultural commodities according to Good Agricultural Practice. 

The above list of potential advantages of automated immunostainers summarizes their strengths. Automation cannot, however, correct faulty cell or tissue preparahve techniques, which would lead to the failure of any immunostaining method. Automated staining also cannot correct for the improper selection of tissue to be examined, or for selection of antisera and associated reagents that produce nonoptimal or inconclusive results. Automation is no panacea for laboratories that have poor quality control procedures, since good laboratory practices are required to operate automated Stainers successfully. 

An example of the application of this procedure for testing the equivalence of the albendazole or ivermectin MRLs for which differences exist between the United States and JECFA is presented in Table 12.5. Differences between US and JECFA MRLs for albendazole are due to use of different safety factors and to the JECFA consideration of good veterinary practice. That is, JECFA considered practical conditions of use of the drug and set MRLs consistent with that use accordingly, the entire ADI is likely not to be consumed. On the other hand, the United States always uses the entire ADI in setting MRLs for edible tissues. 

Animal tissues used to produce enzymes must comply with the applicable U.S. meat inspection requirements and must be handled in accordance with good hygienic practices. 

A9.5.2.3.4 High quality data are defined as data where the validity criteria for the test method applied are fulfilled and described, e.g. maintenance of constant exposure concentration oxygen and temperature variations, and documentation that steady-state conditions have been reached, etc. The experiment will be regarded as a high-quality study, if a proper description is provided (e.g. by Good Laboratory Practice (GLP)) allowing verification that validity criteria are fulfilled. In addition, an appropriate analytical method must be used to quantify the chemical and its toxic metabolites in the water and fish tissue (see section 1, Appendix III for fiirther details). 

Meat and Bone Meal is the rendered product from mammal tissues, including bone, exclusive of any added blood, hair, hoof, horn, hide trimmings, manure, stomach, and rumen contents, except in such amounts as may occur unavoidably in good processing practices. It shall contain a minimum of 4.0% phosphorous (P), and the calcium (Ca) level shall not be more than 2.2 times the actual phosphorous (P) level. 

---