Good Laboratory Practice(GLP) is related to drug registration. It is a regulatory document that non-clinical trials used to evaluate drug safety need to comply with. Many new drugs entered the clinic after simple animal experiments showed that they had certain effects and were not very toxic. At the same time, the clinical trial was too hasty and caused serious medication accidents. In a sense, GLP and other related drug legislation were born with repeated pharmacological incidents. In recent years, biotechnology drugs have become the focus of research and development, and bioanalysis has gradually been valued by companies because of its important role in the early development of biotechnology drugs. It is also important to do a good job of GLP bioanalysis in the laboratory. The experimental research of Medicilon’s biological analysis service department meets the requirements of FDA/CFDA GLP standards. The service content covers pharmacokinetics, pharmacodynamics, immunogenicity and bioequivalence research, and provides customers with small molecule drugs and biological preparations. , The screening and development of vaccines and biomarkers, as well as preclinical and clinical research.
GLP is mainly divided into two parts: hardware and software. Its core is to ensure the authenticity, completeness and reliability of research materials. Hardware requirements: A complete set of experimental facilities and automated equipment is an important guarantee for the smooth progress and high-quality completion of the toxicity evaluation work.
Feeding and management facilities of different species of animals or different experimental systems. Small animals: barrier system (ten thousand), suitable for SPF grade animals; large and small animals: sub-barrier system (100,000 grade), suitable for clean grade animals; large and small animals: open system, suitable for ordinary grade animals.
Animal quarantine and isolation treatment facilities for sick animals.
Facilities for collecting and processing test waste.
Cleaning and disinfection facilities.
Corresponding breeding and management facilities should be set up when the test product and reference product contain volatile, radioactive and biohazardous substances.
The temperature is controlled at 20±3℃, the relative humidity is 30%~70%, the air is circulated and filtered, and the light is 12h to control noise.
According to their performance characteristics, laboratory equipment can be divided into: functional technology, and its corresponding equipment configuration requirements: 16 items such as electrocardiograph, constant temperature water bath perfusion system, microcirculation microscope, etc.; morphological and technical equipment configuration requirements: stereo microscope , Inverted microscope, ultra-clean workbench, etc. 23 items; equipment configuration requirements for analytical technology: high-speed centrifuge, spectrophotometer, precision analytical balance, high performance liquid chromatography, etc. 22 items; synthesis (extraction) and preparation process technology Equipment configuration requirements: 35 items such as vacuum drying oven, rotary evaporator, and gas chromatograph.
Corresponding equipment should be kept by a dedicated person, and a label indicating whether it has passed the measurement inspection, the name of the person in charge, the manufacturer, and the date of delivery should be affixed.
Instruments and equipment should be regularly verified, verified, tested and calibrated, and maintained and maintained to ensure stable and reliable performance of the instruments and equipment.
Standard operating procedures for the maintenance, calibration and use of the equipment should be prepared.
For the use, inspection, testing, calibration and fault repair of equipment and equipment, the date, relevant conditions and the name of the operator should be recorded in detail.
Reagents and solutions should be labeled with product name, concentration, storage conditions, configuration date and expiration date.
The test product and reference product should be labeled with the product name, abbreviated name, batch number, expiry date and storage conditions.
Corresponding ventilation, anti-acid and alkali and fire prevention facilities should be provided.
Establish a complete organization and management system: appoint the person in charge of the organization, the person in charge of the quality assurance department and the corresponding quality assurance staff; have the corresponding researchers; develop a complete management system, and the responsibilities of personnel at all levels are clear.
A high-quality staff team: with rigorous scientific style and good professional ethics; with corresponding academic qualifications, professional training, with the knowledge structure, work experience and business ability required to complete the research work undertaken, the staff Only after professional training is required; familiar with the basic content of GLP, and strictly perform their respective duties.
The standard operating procedures (SOP) safety evaluation research results of various tasks can be affected by a variety of subjective and objective factors. In order to minimize these effects and prevent the occurrence of “false positive” or “false negative” results, In order to facilitate the “cause” inspection, SOPs must be drawn up for all aspects involved in the safety evaluation research experiment. The SOP must be practical, specific, and easy to implement. Its content should at least include title name, number, text, reference, revision number, maker, reviewer, approver, approval date, page number, and total number of pages.
Making test record documents
The possibility of accidental errors in various recorded documents exists in all aspects of the experimental process. It is required that all operations and all situations that occur at all times during the implementation of the experiment should be recorded regardless of size. These records become very important evidence when evaluating the credibility of experimental results objectively afterwards. There are many types of documents and materials to be produced, and each research institution needs to adopt effective methods to produce record documents suitable for the application of the organization in accordance with the actual situation of the organization and according to its own purposes.
There must be a good experimental facility and equipment, a strict management system, a strict design plan and a reasonable SOP, and the implementation must be carried out without compromise, so as to ensure The research work was completed normally, smoothly, on time and with high quality. The Quality Assurance Department (QAU) is an independent organization. Its personnel do not participate in the experimental process. Its supervision and inspection is an important measure to ensure the quality of experimental data. Supervise and inspect whether the operation, original data and summary report comply with GLP specifications. With the expansion of the scope of GLP application, the establishment of a GLP system and GLP laboratory that meet international standards as soon as possible can ensure the authenticity and accuracy of experimental results and ensure the safety of clinical medication. It can further improve the strength and level of my country’s new drug research and development, integrate with international standards as soon as possible, participate in international competition, and ensure human health.
Medicilon successfully passed the US FDA GLP on-site inspection
Relevant
news
marketing@medicilon.com
