GLP

GLP

What is good laboratory practice?

Nowadays, due to the expansion of pharmaceutical companies, laboratories of cosmetic companies and laboratories that perform toxic tests, the need to control the quality of products and data is felt more than before.

During its activities, any laboratory may encounter problems such as missing information, reports that are not accurate enough, reports verified by unauthorized persons, uncalibrated devices, etc. To solve such problems, laboratories need to follow a series of rules known as good laboratory practice or GLP.

Good Laboratory Practice (GLP) is a quality control system including management controls for laboratories and research organizations to ensure the uniformity, consistency, reliability, quality, and integrity of chemicals from This includes drugs as well as non-clinical safety tests for physico-chemical properties.

In other words, the data produced using GLP methods are a true reflection of the work or study and are traceable to internationally accepted standards.

In this article, we want to talk about GLP and the correct methods of doing it in the laboratory and how FG products are useful for achieving GLP standards in the laboratory environment.

GLP was first introduced in 1972 in New Zealand and Denmark. GLP was established in the United States following cases of fraud by toxicology laboratories in data submitted by pharmaceutical companies to the FDA. Among industrial Bio Test laboratories, IBT was the most prominent case, where thousands of safety tests were falsely claimed to have been carried out for chemical manufacturers. So that the data was so poor that the police investigators could not understand what tests were done.

This issue led the US Food and Drug Administration to present regulations under the title of Good Laboratory Practice in 1976.

GLP applies to non-clinical studies conducted to evaluate the safety or efficacy of chemicals (including drugs) in humans, animals, and the environment.

  • Improving the quality of test data
  • Preventing repetition of experiments and reducing the time spent on research activities
  • Improving the protection of human health and the environment
  • Facilitating acceptance of test data by international organizations and traceability of results
  • Preventing the creation of commercial technical barriers

The GLP Code sets out the rules for good practice, which are generally summarized in 5 principles, and help researchers to conduct their experiments according to predetermined plans and standard procedures.

  1. Sources: Including human resources, organization, facilities and equipment
  2. specifications: Including test material and test system
  3. Current rules and regulations: including protocols, SOP and various strategic aspects of tests
  4. Documenting the results: Raw data, final report and archives
  5. quality guarantee

 

1 Resources

 

human resources

GLP regulations require that the number of personnel is proportional to the scope and volume of laboratory activities. The competence of the employees to carry out the assigned responsibilities must also be confirmed by the technical director of the laboratory.

All personnel upon arrival and according to the responsibilities assigned to them, must go through the necessary specialized and safety training. The records of these trainings and their effectiveness evaluation should be recorded and archived, and the technical manager should be sure of the effectiveness of the trainings.

organization

The infrastructure and design of the laboratory should be such that it provides favorable conditions for testing and the safety of personnel and makes it easy to perform the test correctly. For this purpose, it is necessary to pay attention to the following points:

  • The size, structure and location of the laboratory should be appropriate to the scope of activity.
  • Sources of environmental pollution should be considered and any pollution should be prevented as much as possible.
  • Sources of environmental pollution should be considered and any pollution should be prevented as much as possible.
  • The space of the laboratory should be such that the maintenance of materials and equipment, cleaning and disinfection are easily possible.
  • The laboratory must have a suitable environment for receiving and storing samples so that there is no possibility of contamination of the sample and the sample is kept in suitable and controlled environmental conditions as needed.
  • The place for performing microbiological experiments should include at least 3 separate sections for preparation and sterilization of culture medium, culture room and incubation room.
  • Hazardous materials such as chemicals and microbial strains should be stored in a suitable place and safety cabinets and special shelves should be used to store them.
  • Chemicals that may react with each other should be stored separately.
  • The place where the records are kept, the personnel locker room, etc. should be proportional to the amount of documents and the number of employees.
  • The space inside the laboratory, based on the type of activity, should be made of resistant materials suitable for the type of experiment. For example, the walls, ceiling and floor should be easy to clean and their surface should not be slippery. The design of the windows should prevent the entry of dust.

Materials and equipment

Each laboratory must have an implementation method to purchase and prepare the necessary equipment and supplies that affect the quality of the test. It is also necessary to develop a suitable method for evaluating suppliers and contractors. This evaluation should be done based on a set of predetermined criteria. The records of these evaluations should be recorded and archived so that they include the supplier’s name, address and scope of activity. Equipment repair and calibration records should also be recorded and archived in the same way.

The records of each equipment must include at least the following:

  • Equipment identification code
  • The name of the manufacturer and the unique specifications of the equipment such as the serial number
  • Location
  • Environmental conditions
  • How to work with the device and manufacturer’s instructions
  • Repair and calibration records

 

2-Specifications

 

To perform the test correctly, it is necessary to know as much as possible about the sample and the equipment used during the test. One of the principles of good laboratory operation is knowing and properly handling the test substance (often a chemical compound) and the test system (often a living animal).

 

3 Current laws and regulations

 

The rules that an organization has established for good laboratory operations should be defined and recorded in the form of documents that are approved by management. These rules clearly define what each person is responsible for and how the processes are carried out. These documents are classified into 2 groups:

  • The protocol (or study design) that describes how to design and conduct the study. For example, the time period considered for conducting the study or experiment.
  • A standard operating procedure (SOP) that provides detailed instructions on how to perform each test and properly organize its environmental conditions and data.

 

4 Documenting the results

 

Each of the test steps follows data. These data are recorded in the final test report and represent the final result of a test. For this reason, it is very important that the data is collected completely and has accuracy and integrity. This section of the Good Laboratory Practice Rules deals with the collection, documentation, and reporting of test results.

What are the principles of final reporting of the test?

The test results must be recorded and reported with full accuracy and clarity without any ambiguity. The documentation of these reports can be done both in written (paper) and electronic form, and the minimum information that should be included in it includes the following:

  • Name and address of the test center
  • Identification number and test start and end date
  • Details of test materials and equipment
  • Method and reference used
  • Name and place of sending the sample
  • Specimen specifications (production series, production date, expiration date, weight, etc.).
  • summary of results
  • Signature of Quality Assurance Manager
  • Examiner’s signature

 

5 Quality assurance

 

One of the important principles of good laboratory operations is quality assurance, which, as an independent internal entity, controls all policies and procedures related to testing.

The Quality Assurance (QA) unit is a group of people with a set of defined tasks that oversee the correct performance of all processes related to quality control implemented in the test. In fact, it can be said that the main mission of the quality assurance system is independent monitoring of the entire research process and its organizational framework.

All laboratory equipment produced by FG ​​has the necessary standards for good laboratory operation. In the rest of this article, we take a look at FG laboratory equipment and their standards in good laboratory operation.

Stability test chambers in ‘Good Laboratory

 

Drug stability test chambers or temperature and humidity chamber (STABILITY TEST CHAMER) is a device that is very important and necessary by creating special environmental conditions for pharmaceutical ICH tests. Drug sustainability tests are an important part in the development of pharmaceutical and medical sciences, which doubles the importance and sensitivity of the chambers. From stability chambers, mainly for taking tests ICH GUIDLINE Q1A It is used to place the drug in different temperature and humidity conditions, for example, 40 degrees Celsius and 70% humidity, and measure the stability of the drug, which must follow the strict requirements of quality assurance systems. These requirements may include installation and operational qualification, calibration certificates (including light certificates) and independent parameter recording.

 

Another important point of the FG stability test chamber is the ability to calibrate the device. If the calibration is 1 point, the device is calibrated only at the same point, and by calibrating at one temperature, the calibration of other temperatures is out of adjustment. Some devices are calibrated in two temperatures, in this case, the device considers a hypothetical line based on these two temperatures and calibrates the rest of the temperatures based on this hypothetical line. Since some points may not be in accordance with the assumed line of the device, calibration in two points cannot be a guarantee of high accuracy of the device, therefore, the more calibration points, the more accurate calibration is performed and the device works accurately in the entire temperature range. FG equipment is calibrated in 6 temperature points.

According to today’s world standards, the temperature of the chamber should be controlled by an independent thermostat, so that when necessary, by cutting off the voltage of the element, they prevent the increase of the temperature of the chamber and avoid possible damages. The safety thermostat is separate. The ability to connect to FGLAB software is another advantage of this device. By connecting to this software, you can view all device information including temperature, humidity and fan speed in the form of graphs and tables. Also, according to the requirements of pharmaceutical factories, it is possible to provide QUALIFICATION documents including IQ, OQ, PQ for FG products.

 

cooled Incubator for Microorganisms in ‘Good Laboratory

 

A cooled incubator should enable GLP-compliant testing of samples such as bacteria and fungi. Achieving this goal requires a very precise method of temperature control.

One of the most important advantages of FG incubators is isothermal at all points of the chamber and thermal stability, and for the first time in Iran, it has brought uniformity at 27 points of the chamber. Another important advantage is temperature stability even in cooling mode, which is made possible by using NON-CUT technology.

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