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According to Circular No. 36/2018/TT-BYT, in the drug manufacturing industry, drug production and storage facilities need to comply with GSP standards. So what is GSP? How do GSP standards and warehouses achieve GSP in the pharmaceutical industry? Which consultancy unit applies the GSP standard? Find out and contact GMP Groups as soon as you ask!

01

GSP standards in Vietnam

1.1. What is the GSP standard?

GSP (Good Storage Practice) is understood as a standard of good practice for drug preservation. These standards include appropriate measures for the preservation and transportation of raw materials and products at all stages of production, storage, storage, transportation and distribution of drugs to ensure quality drug finished products reach users.

1.2. The introduction of GSP standards in Vietnam

To ensure the quality of medicines and ingredients for making medicines, the control must be started from the input material until the composition of the finished product. One of the stages that affects the quality of the product is the storage process. Materials purchased or finished products must be stored under appropriate conditions to maintain quality according to their longevity.

Recognizing the great role of preservation in pharmaceutical production activities, in the good manufacturing practice guide (GMP) there are separate items required for specific warehouse systems. Moreover, the World Health Organization (WHO) has drafted and issued a “Good Storage Practices” to clarify and in more detail the construction of facilities and quality management systems of warehouses for the preservation of pharmaceutical products,

In Vietnam, on the basis of GSP-WHO, the Ministry of Health has drafted and issued guidelines for good preservation. In particular, there are more specific and detailed contents and regulations in line with the reality in Vietnam applicable to drugs and raw materials for making drugs; traditional medicines and medicines, non-commercial establishments and medical examination and treatment establishments are shown in Circular No. 36/2018/TT-BYT.

View circular 36/2018/TT-BYT here.

02

When are businesses required to apply the GSP standard?

The 2016 Law on Pharmacy clearly states that all types of pharmaceutical business must meet the requirements of “good practice of preserving medicines and medicinal materials” including:

– Establishments importing drugs and raw materials for making drugs

– Export establishments of drugs and raw materials for making drugs

– Establishments trading in drug preservation services and drug-making raw materials.

03

GSP storage warehouse requirements

Just like good practice guidelines for drug production, in order to meet GSP standards the business establishment must build hardware and software. In which hardware is a factory system, machinery and equipment. Software is a process system, document records.

3.1. Requirements for GSP-standard storage warehouse hardware

Kho bảo quản tiêu chuẩn GSP

GSP Standard Storage Warehouse

Requirements for workshops and equipment are described in detail in Circular No. 36/2018/TT-BYT. In the scope of this introduction GMP Groups only emphasizes a number of important points:

a) The warehouse must have a certificate of fire prevention and fighting (FIREFIGHTING).

This is an important document in the inspection process, as well as a document that must submit a list of applications for GSP certification.

b) Functional areas must be clearly divided in accordance with GSP guidelines.

Storage warehouses must basically have the following functional areas:

– Warehouse office, costume replacement area

– Reception and cleaning area.

– Reserve area waiting for testing

– Approved material storage area

– Recovery-return storage area

– The storage area is removed.

– Sampling area

– Secondary labeling area (if necessary)

– Export area 

c) The warehouse area must be sufficient for storage activities

Some preservation activities require a mandatory minimum area such as the preservation of medicinal herbs and traditional medicines.

d) The layout of the areas in the warehouse must be optimized in a convenient one-way direction during the storage process.

e) Ventilation and air conditioning systems must determine the appropriate cold and wind capacity to ensure product conditions as well as working environment for humans.

f) Areas for storage of specially controlled materials and drugs must comply with security control, avoid confusion and loss.

g) The warehouse must be tight-kept, avoiding the penetration of insects, termites, special rodents in the receiving and exporting area.

h) In order to meet the requirements of preventing termite insects and rodents in the warehouse, it is recommended to arrange mosquito-catching lights in open areas with external environments such as reception and export doors, ventilation doors must have insect nets installed, around the warehouse must plan and arrange traps for rodents …

i) Forklifts, trolleys, weighing equipment, humid thermometers… You have to invest enough. Weighing, humid heating must be periodically tested and calibrated. Besides the usual humid heat at each important storage warehouse, there is a self-recorded humidifier to monitor temperature and humidity online during storage.

k) The shelf system must be determined based on the load of goods to be preserved, rated as a shelf price to recognize and install the pricemeter must take into account the height of warehouses, human paths, goods. At each shelf, a list of goods showing the goods being preserved on the next rack must be listed. 

l) The sampling area in the warehouse depends on the nature of the preserved material and finished product, which must be designed appropriately for sampling activities and maintain the quality of the product.

Mẫu giấy chứng nhận đáp ứng tiêu chuẩn GSP

Form of certificate meeting GSP standards

3.2. Requirements for GSP-standard storage software

GSP-compliant storage document documentation process system is divided according to a stratified structure with 3 main levels

Level 1: the overall documents include: overall profile, quality handbook

Level 2: Instructions, operation processes, technical standards

Level 3: Records, drawings, external documents.

Documents and application processes at different levels must be built so that there is alignment and consistency in accordance with reality, so that when training and applying in practice must be strict, easy to understand, easy to comply with for people. From there, it will create a team of personnel with a strong quality management system.

In addition to investing in good infrastructure, facilities/enterprises must pay great attention to building a system of document records and training personnel to apply the operation of that document system.

04

GMP Groups - a provider of consulting services to build GSP standards all-inclusive

4.1. Consulting, designing factories, auxiliary systems of GSP standard storage warehouses.

GMP Groups with a team of personnel with many years of operation in pharmaceutical companies, are regularly exposed and trained in a good practice environment (GMP, GSP, GLP). In addition, the design team has many years of experience in the field of clean room design – pharmaceutical storage guaranteed to advise and design for customers in the most reasonable way between customer requirements and GSP standards.

Bản vẽ thiết kế Kho bảo quản dược liệu phục vụ xuất khẩu

Design drawing of pharmaceutical storage warehouse for export

4.2. Construction of factories, auxiliary system of GSP standard storage warehouse

GMP Groups specializes in implementing projects to build pharmaceutical factories, TPBVSK. This includes GSP-standard storage warehouses. GMP Groups is committed to ensuring the quality of construction and construction schedule with the highest sense of responsibility.

4.3. Services to set up document records system, standard operation process

GMP Groups provides customers with the most streamlined and complete set of processes and documentation. Thereby, customers understand the process system, document records for GSP standard storage warehouse.

4.4. Service to prepare applications for GSP certificate

GMP Groups will assist customers in preparing applications for GSP certification. We monitor and help customers replenish documents as needed.

GMP Groups is committed to ensuring that customers obtain GSP certifications. We support customers to overcome the backlog after each inspection and maintenance of the factory during production activities, renovate the factory according to the customer’s requirements.

For more information about GSP 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