答:声明应简洁,并指出研究是GLP豁免的。
3.对于合同非临床实验研究,谁负责准备依从性修正案中所要求的GLP说明?
答:制定依从性修正案声明是产品项目资助者的职责,而此声必须作为研究许可证申请或上市许可证申请的一部分而提交。然而,合同人必须为主办者辨别每一非临床实验研究中的非GLP行为,以便编写正确的依从性修正案声明。
4.谁在依从性修正案声明上签字?
答:在依从性修正案声明上签名的人与在法定的研究许可证申 请或上市许可证申请上签字的人,可以是工厂里的同一个人。
5.每一非临床试验研究都必须准备有关条款所要求的特定的依从性修正案声明吗?
答:是的。对于所有非临床实验室都必须鉴定GLP偏差。任务的完成可以通过制定一份说明,其中包括各个正式档案中的所有安全性研究。正式档案中的依从性修正案声明与动物安全性研究的档案必须安排在相接近的位置。
十三、总则
1.自1979年6月20日以来,是否有过不合格的非临床实验室? 答:没有。
2.FDA是否拒绝没有完全按照GLP进行的非临床实验研究?
答:不一定。GLP的实施计划对这个问题提供了指导。FDA 要想拒绝一项研究,必须找到与GLP不相依从之处,而且FDA必须在检查时发现,与GLP的偏差实质上损害了研究的质量和完整性。
3.SOP的副本必须与研究许可证申请或上市许可证申请一同呈送吗? 答:不必。
4.对于在完成以前就被中止的非临床实验研究应该做些什么?
答:主管机构承认许多情况(疾病暴发、停电等)都可能导致非临床实验研究的过早中止。在这些情况中,必须拟定短期的总结报告以说明研究中止的原因。
5.对于动物设施的环境控制(温度、湿度和照明),主管机构是否制定了允许限度? 答:没有。这是科学问题,必须在实验方案中予以说明。当然,必须保存准确记录。
来源: 国家认证中心
美国FDA对GLP常见问题的答复(英文版)
FREQUENT QUESTIONS AND ANSWERS (FQA)
OF FDA ON GLP
FREQUENT QUESTIONS AND ANSWERS （Chinese Version）
Since June 20, 1979, the agency has been asked many questions on the Good Laboratory Practice regulations (GLP's, 21 CFR 58). In accord with agency procedures, responses have been prepared and copies of the associated
correspondence have been filed in the Dockets Management Branch (HFA-305). The responses have also been provided to the bioresearch monitoring program managers and to the district offices in order to ensure consistency of interpretation and equity of program operation. Unfortunately, the numerous filed
correspondences contain many repeat questions that are not categorized to relate to the specific GLP suppart and section. On occasion, the answers appear to be somewhat cryptic. These disadvantages serve to limit the utility of the correspondences as advisories to our headquarters and field offices.
This document, therefore, consolidates all GLP questions answered by the agency during the past 2 years, clarifies the questions and answers as needed, and relates the questions and answers to the specific pertinent provisions of the GLPs. It represents a digest of some 30 letters, 160 memoranda of telephone conversations, 34
memoranda of meetings and 30 miscellaneous correspondences that have been issued by agency personnel. The document does not duplicate questions and answers that were dealt with in the August, 1979 Post Conference Report on the Good Laboratory Practice Regulations Management Briefings.
This document should be reviewed by field investigators proir to making GLP
inspections and by headquarters personnel involved in the GLP program. Questions should be directed to :
Dr. Paul D. Lepore
Bioresearch Monitoring Staff, HFC-30
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
301-443-1390
SUBPART A
GENERAL PROVISIONS
Section 58.1 Scope.
1. Do the GLPs apply to validation trials conducted to confirm the analytical
methods used to determine the concentration of test article in animal tissues and drug dosage forms? No.
2. Do the GLPs apply to the following studies on animal health products:
overdosage studies in the target species, animal safety studies in the target species, tissue residue accumulation and depletion studies, and udder irritation studies? Yes.
3. Do the GLPs apply to safety studies on cosmetic products?
No. Such studies are not carried out in support of a marketing permit. However, the GLPs represent good quality control; a goal that all testing facilities should strive to attain.
4. Do safety studies done to determine the potential drug abuse characteristics of a test article have to be done under the GLPs?
Yes they do, but only when the studies are required to be submitted to the agency as part of an applicaion for a research or marketing permit.
5. Do the GLPs apply to the organoleptic evaluation of processed foods? No.
6. Do the GLPs apply to all of the analytical support work conducted to provide supplementary data to a safety study?
The GLPs apply to the chemical procedurs used to characterize the test article, to determine the stabilitly of the test article and its mixtures, and to determine the
homogeneity and concentration of test article mixtures. Likewise, the GLPs apply to the chemical procedures used to analyze specimens (e.g. clinical chemistry,
urinalysis). The GLPs do not apply to the work done to develop chemical methods of analysis or to establish the specifications of a test article.
7. Is it possible to obtain an exemption from specific provisions of the GLPs for special nonclinical laboratory studies?
Yes. The GLPs were written with the aim of being applicable to a broad variety of studies, test articles and test systems. Nonetheless, the agency realizes that not all of the GLP provisions apply to all studies and, indeed, for some special studies certain of
the GLP provisions may compromise proper science. For this reason, laboratories may petition the agency for exemption for certain studies from some of the GLP provisions. The petition should contain sufficient facts to justify granting the exemption.
8. Are subcontractor laboratories that furnish a particular service such as
ophthalmology exams, reading of animal EDGs, EEGs, EMGs, preparation of blocks and slides from tissues, statistical analysis and hematology covered by the GLPs?
Yes, to the extend that they contribute to a study that is subject to the GLPs.
Section 58.3 Definitions.
1. Are animal cage cards considered to be raw data?
Raw data is defined as \are the result of original observations and activities?.and are necessary for the reconstruction and evaluation of the report of that study.\ Cage cards are not raw data if they contain information like animal number, study number, study dates, and cage number (information that is not the result of original observaions and that is not necessary for study reconstruction). However, if an original observation is put of the cage cards, then all cards must be saved as raw data.
2. Are photo copies of raw data which are dated and verified by signature of the copier considered to be \ Yes.
3. Are records of quarantine, animal receipt, environmental monitoring, and instrument calibration considered to be raw data? Yes.
4. A laboratory conducts animal studies to establish a baseline set of data for a different test species/strain. No test article is administered but the toxicology
laboratory facilities and procedures will be used and the resulting data may eventually be submitted to the agency as part of a research or marketing permit. Are the studies considered to be nonclinical laboratory studies that are covered by the GLPs?
Generally, a nonclinical laboratory study involves a test article studied under
laboratory conditions for the prupose of determining its safety. The cited example does not fit the definition so it would not be covered by the GLPs. Since the data from the baseline studies may be used to interpret the results of a nonclinical