Quality assurance Amendments

The FDA established a GLP review task team to identify provisions in the regulations that could be amended or deleted, and this team recommended revisions to 36 GLP provisions. Recommendations were issued as a proposed rule on October 29, 1984 [15]. The proposal made various changes to definitions to reduce the amount of paperwork required for nonclinical laboratory studies and to clarify earlier GLP provisions. Similar clarifications were made to the provisions, delineating the definition and function of the study director and quality assurance unit. 

This may certainly prove to be difficult at times, especially in the context of a study of relatively short duration. In such a case, one can imagine that the Study Director would possibly have had to decide on the spot about some necessary (but nevertheless planned) change. To dictate the amendment and to have it typed by the secretary, or to go back to the office and to type it himself, to date and sign it, and to distribute the necessary copies to all the persons concerned, including the Quality Assurance, would in such a case take too much time. Unless the change could be immediately implemented (and the amendment written later), the study would in all probability have to be aborted. Thus, a certain latitude in the interpretation of the resemblance of an amendment with the study plan can certainly be exercised. When, however, in longer term toxicity or field studies amendments are uncovered that are concerned with some start parameters of the study, but which are written (or at least dated and signed) well after the experimental start date, or maybe even after the experimental study completion date, then the correct term for such a document is certainly not Amendment anymore, because in this instance it has failed the intentions of the GLP Principles, namely that the amendment... 

One such case may be the question of report amendments. If a report should have to be amended, because either further data from other studies may have invalidated some of the conclusions drawn in the original report, or because an error has been detected which had escaped earlier on the attention of the Study Director and the Quality Assurance, then this amendment to the report will again have to be audited by the Quality Assurance, which will furthermore have to prepare an amendment to the former Quality Assurance statement. 

The Clinical Laboratory Improvement Amendments (CLIA) set standards designed to improve the quality of all laboratory testing. In the first portion of this chapter, we discuss the CLIA requirements that apply to most Immunohistochemistry laboratories, and explain topics such as certification, test complexity, patient test management, proficiency testing, personnel, quality control, quality assurance, and compliance. 

Special form radioactive material manufactured to a design which had received unilateral approval by the competent authority under the 1973, 1973 (As Amended), 1985 or 1985 (As Amended 1990) Editions of these Regulations may continue to be used when in compliance with the mandatory programme of quality assurance in accordance with the applicable requirements of para. 306. All special form radioactive material manufactured after 31 December 2003 shall meet this Edition of the Regulations in full. 

The Safe Drinking Water Act (SDWA), enacted in 1974 to assure high-quality water supplies through public water system. The act is truly the first federal intervention to set the limits of contaminants in drinking water. The 1986 amendments came two years after passage of the Hazardous and Solid Waste Amendments (HSWA) or the RCRA amendments of 1984. As a result, certain statutory provisions were added to these 1986 amendments to reflect the changes made in the underground injection control (UIC) systems. 

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