Essentials of Good Laboratory Practices (GLP)

Quality Product testing is the backbone for promotion of global trade. A product tested and approved to meet defined specifications should qualify when tested in any other laboratory.

Good laboratory practices (GLP) are an essential ingredient of a quality system that ensures uniformity, consistency, reliability and reproducibility of data. In other words the data generated using GLP practices is a true reflection on work or study and is traceable to internationally accepted standards.

ISO has evolved several standards that strengthen GLP practices.ISO 17025:2005特别是制定了校准和测试实验室认证的准则。

毒品和化妆品规则laid down by government of India refer to GLP guidelines in schedule L – 1.
经济合作与发展组织（OECD）national guidelines promote the quality and validity of test data used for chemicals and chemical products.

GLP Requirements

GLP requirements fall under different heads and the essentials of each are briefly outlined below:

一般要求

这些与涉及的计划过程有关：

• Developing policy and quality plan to achieve organization objectives
• 设计组织结构以执行计划
• Dividing the total work in logical pattern and assigning responsibility for each activity
• 定义内部部门工作的关系和协调以及与外部机构的互动以实现公司任务
• Design system for quality evaluation, audits and surveillance of products

Premises

• Laboratory should be located in area free from noise, dust and vibrations
• Layout planning for different sections to avoid cross contamination
• 测试和存储区应分开，仅限于授权人员
• 应该提供足够的空间来执行测试程序
• An effluent treatment plant is necessary if laboratory waste contains harmful pollutants
• 建议进行集中空调以减少交叉污染和控制水分水平
• Floors should be impervious and washable

动物屋设施

在这方面，应考虑与预防虐待动物有关的所有规则

人手

人员是任何组织中最重要的资源。实验室应拥有足够的员工，具有所需的教育背景，并能够履行质量经理的所有责任。应进行熟练程度测试和各种培训计划，以提高个人知识和技能。

Equipment

• 测试实验室应提供并维护测试程序所需的合适设备。
• Maintenance, calibration and validation of equipment is necessary to keep equipment in good working condition and improve both the efficiency and accuracy of results
• 应为所有新工具以及添加主要配件时，应执行安装资格智商，运营资格（Oó）和绩效资格（PQ）。
• Analytical instruments should be kept in clean environment with controlled temperature and humidity. Records of temperature and humidity should be maintained and made available whenever required.
• 仪器应在整个过程中进行校准，并应将有缺陷的仪器标记为“ Out Out Out”直到修理

化学和试剂

化学和试剂should be stored and labeled according to their physicochemical properties. The label should clearly indicate date of expiry.

SOP应该在那里准备解决方案和标准化

Reference Materials

Reference materials use is recommended due to their due to their high purity, critical characteristics and suitability

参考标准可用于准备辅助标准或具有可追溯性的工作标准

Quality Systems

质量手册是有助于主文档maintain the product quality and is the permanent reference for the implementation and maintenance of quality system which describes both the management requirements as well as customer requirements.

标准作业程序

标准作业程序are documented procedures in chronological order listing established procedures and processes essential for upkeep of established quality management systems.

良好的管家和安全

Written instructions for good housekeeping and should be communicated to the staff through handouts, audio visuals or other methods.

Audits

Both internal and external audits should not be considered additional burden but on the contrary help maintain and improve quality standards.

简要介绍了概述要求。GLP本身就是一个广阔的领域，可能会有变化，使个人实验室的创新范围在定义自己的质量政策时进行创新。

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关于the Author:

Mahima Agarwal is a pharma professional specializing in Pharmacognosy. After her postgraduation from Rameesh Institute, Greater NOIDA, India she is working with Arbro Pharmaceuticals, New Delhi for last 2.5 years. Mahima has rich exposure to analysis and standardization of herbal medicines and health supplements.