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Any product before launching to the market must pass quality control and meet GLP standards. Let’s see what the GLP standard is with GMP Groups. What requirements do GLP-standard laboratories meet!

01

What is the GLP standard?

GLP (Good Laboratory Practice) or “Good Laboratory Practice” is a set of principles and standards for quality management systems related to the organization process and conditions for conducting non-clinical research in pharmaceutical activities for human health and environmental safety planned, implementation, monitoring, recording, storage and reporting.

GLP is applied in many different fields of testing activities, especially for the pharmaceutical industry, GLP means “Good practice in the drug testing laboratory”.

02

Subjects applying glp principles in the laboratory

+ Drug testing establishments, self-selected drug ingredients apply and meet GLP standards.

+ Testing establishments of vaccines, medical products, blood products, bio-service products and trading establishments are applied and meet GLP standards.

+ The basis for applying GLP standard documents.

03

Requirements of the glp standard laboratory?

3.1. Laboratory requirements

The laboratory is full of functional areas such as:

+ Physiological, microbiological and chemical testing area

+ Machine room for analytical equipment

+ Room for thermostats

+ Chemical warehouse, sample storage room, dressing room …

– The laboratory needs to ensure that it meets the standards of temperature, light, humidity. The temperature should be less than or equal to 30°C. Humidity is less than or equal to 75% compared to devices such as infrared spectrometers, Karl Fischer machines…

– The laboratory must not be unedited, smog, affected by noise or electromagnetic infection … Make sure not to falsify the results or affect the accuracy of the measurements.

In addition, in order to comply with GLP’s principles, the laboratory needs to have requirements such as:

+ Equipment system

+ Qualified staff, suitable to job requirements and continuously trained

+ System of records, documents, clear implementation instructions for easy implementation

To conduct effective and accurate testing, it is necessary to understand the requirements of the principles of the GLP standard.

Phòng QC công ty sản xuất dược phẩm

QC Department of Pharmaceutical Manufacturing Company

3.2. Inspection supervision of the maintenance of meeting the standard of Good Laboratory Practice::

– Every year, on the basis of assessing the risk of the impact of meeting glp principles and standards, the results of drug quality monitoring monitoring, the Drug Administration shall develop a plan and carry out inspection and supervision, unscheduled inspection of the maintenance of compliance with the principles, GLP standard at the facility.

– In case the facility does not meet the GLP, the Drug Administration will take one of the measures:

Pause part or all of the testing.

+ Submit to the Minister of Health to suspend the effectiveness

+ Revoke the Certificate of eligibility for pharmaceutical business

+ Narrow the scope of testing activities stated on the Certificate of eligibility for pharmaceutical business.

+ Suspend operations, narrow the scope of operation for non-commercial testing facilities.

04

GLP applied training and consulting services of GMP Groups

4.1. Prestigious GLP Standard Consulting Unit

+ Confirmation of laboratory information: location, scale of number of tests, scope of application.

+ Consulting on completing the technology of the testing area.

+ Assessment of operating conditions of ptn.

+ Catalog equipment for testing.

+ Support the selection of equipment, tools and consumables for you.

Giấy chứng nhận đạt tiêu chuẩn GLP

FORM of certificate meeting GLP standards

4.2. GLP Standard Basic Training Unit

+ Develop a training plan.

+ Conduct glp drug testing laboratory awareness training course. 

+ Training experts to internally evaluate the management system of good laboratory practice.

Đội ngũ chuyên môn tư vấn hệ thống quản lý chất lượng của GMP Groups

GMP Groups’ quality management system consulting team

4.3. GMP Groups guide the drafting of dossiers, documents

+ Make a list of SOP records and documents.

+ Guidance on the development of a system of process documents / SOP, instructions for the implementation of GLP drug testing laboratory.

+ Guidance on the application of the process text system and how to maintain the document of the results of implementation.

+ Instructions for building IQ, OQ, PQ for testing equipment.

4.4. Completing the application for assessment and issuance of certificates

+ Instructions for completing IQ, OQ, PQ assessments for testing equipment.

+ Instructions for completing ISO documents.

+ Instructions for completing the application for evaluation.

In addition, we offer additional services as follows:

– Guidance on conducting self-inspection and overcoming the existence after self-inspection.

– Guidance on overcoming inappropriate points after the glp evaluation team.

Maintain a glp documented system for subsequent evaluations.

GMP Groups’ training and consulting services help you firmly grasp the basic requirements of the regulations on good practice of GLP drug testing laboratory, ensuring the capacity to implement effectively, effectively, minimizing risks and waste.  At the same time, the benefits are gained from the application of glp drug testing laboratory management system. Thereby improving the performance of operational processes in the organization.

For more information about GLP Advice – Training – Application Guide please contact: 

GMP Groups Joint Stock Company 

Head office: Lot LK20.8, Ecoriver Eco-Investor, Hai Tan Ward, Hai Duong City, Hai Duong Province

Hotline: 02203857968 ~ 0972345486

Website: gmpgroups.com.vn

Email: info@gmpgroups.com.vn

0972 345 486