We understand the concerns of investors when implementing GMP projects. With a team of experienced experts and good relationship with the authorities, INTRACO E&C is committed to providing a complete solution for technology, design, construction and GMP certification services.

1. WHAT IS GMP?

GMP stands for Good Manufacturing Practices, is a guide to good manufacturing practice, applied to manufacturing and food processing and pharmaceutical establishments, in order to control factors affecting the process. forming product quality from the design, construction and installation of factories, processing tools and equipment; conditions of service, preparation for processing to the processing process; packaging, preservation and human control activities during processing and processing.

In a nutshell, GMP covers every aspect of the manufacturing process and quality control.

2. WHAT IS GMP STANDARD?

GMP standard is a system of production practice standards with the aim of controlling factors that can affect the quality formation process of products, in order to ensure that products reach consumers with quality. the best.

It can be said that “what is GMP standard” is a basic standard, a necessary condition for the development of a food safety management system according to ISO 22000.

“What is a GMP standard” needs to be clearly defined, it is a standard that is relevant to all aspects of the manufacturing process and quality control, as well as the management of hazards from the design and installation of buildings. workshop, equipment and machinery, processing tools, input materials to packaging, packaging, processing, preservation as well as training and hygiene of staff, etc. This control helps bring quality management method according to logic, systematic, scientific work and reduce risks in business.

In particular, drug manufacturing enterprises need to comply with GMP standards. With the strict requirements of the current drug market, pharmaceutical enterprises need to apply GMP standards to be able to ensure technical and management conditions to create quality medicinal products to consumers. quality, safety.

3. GMP certification

3.1 Types of GMP certificates

According to the different standard conditions for the production process and the factory, there are different types of GMP certificates:

a. Certified WHO-GMP

WHO-GMP is a mandatory standard for pharmaceutical manufacturing enterprises with the aim of ensuring quality and safe products according to the provisions of Circular 35/2018/TT-BYT on Food and Drug Administration. Good manufacturing practices for drugs and medicinal ingredients. The assessment and grant of GMP-WHO certification are directly implemented by the Drug Administration of Vietnam and the Administration of Traditional Medicine and Pharmacy for each type of scope registered by enterprises.

b. ASEAN-GMP certification.

ASEAN-GMP are the principles required to meet the requirements of manufacturing conditions in the ASEAN Guidelines for Cosmetic Good Manufacturing Practice (ASEAN Guidelines for Cosmetic Good Manufacturing Practice) specified in the “Agreement on ASEAN Harmonized System in Cosmetic Management” is responsible for implementation by the ASEAN Cosmetic Committee.

c. EU-GMP certified.

EU-GMP is a guideline for good manufacturing practice issued by the European Medicines Agency (EMA) – an agency under the European Union EU, responsible for scientific evaluation, testing and drug safety monitoring within the EU.

d. PIC/S-GMP certified.

PIC/S-GMP is the Convention on Drug Inspection and the Good Manufacturing Practices (GMP) Inspection Cooperation Program.

GMP meets the following market and statutory requirements:

1. Ensuring product quality and safety;
2. Ensure jobs are done “right from the start”; Minimize waste and errors.
3. Preventing risks such as product recalls, fines, even legal liabilities,
4. Increased productivity and safety because production processes are streamlined,
5. Increase brand reputation, market share, revenue and profit.
6. The basis for continuous improvement.

3.2 Steps to apply GMP

1. Determining the purpose of applying GMP
2. Define product regulatory & statutory requirements
3. Define quality policy and quality objectives
4. Investigate and identify differences between existing systems and statutory and GMP requirements
5. Establish a GMP system, including ensuring infrastructure and standard operating procedures (SOPs, Standard Operating Procedures)
6. Verify and confirm the use value of the system
7. Implement corrective and improvement actions.

4. GMP consultation process

4.1 Prepare report on investment project of WHO GMP factory

This is the first important work and implementation step for a project to renovate or invest in a new construction of a GMP factory. This work means:

• Systematize the needs and requirements of the Project;
• Making the overall implementation plan, Key Issues on Technology, Production Process and Site Planning;
• Total Investment Cost Estimate, Analyze and consider the effectiveness and feasibility of the Project…

For a GMP factory, regardless of its size, it is considered an investment project and it is necessary to set up an investment project.

 4.2 Consulting on selection of technology and equipment for production and testing

After clearly defining the list and product specifications the project will produce, and the future product development orientation, enterprises need to

• Selecting the technically optimal production technology/process
• Selecting equipment suitable for production technology/process with reasonable investment and operating costs.

Selecting the right process, technology and equipment will ensure the system’s consistency, optimize investment costs and bring about long-term effects during the project’s operation.
Selecting the correct Technology and Manufacturing Process from the very beginning helps in the Design of the Technological Site, Construction solutions, and the selection of the appropriate Auxiliary System, meeting the requirements of the Manufacturing

4.3 Design construction drawings and M&E . electromechanical drawings

M&E infrastructure and systems must be optimally designed according to the specific requirements of technology and production processes and in accordance with GMP principles and standards. When implementing the design of Construction drawings and M&E M&E drawings, the implementation team needs to understand:

• Technology, product manufacturing process
• Requirements of EU, WHO, PIC/S GMP, for Facilities and Ancillary Systems for the production of this type of product
• Actual operating process of the Factory when put into operation

INTRACO E&C is proud to be a pioneering Consultant in Vietnam combining and building a team of experts including Managers, Pharmacists, Bachelors of Chemistry, Biotechnology, Refrigeration and Mechanical Engineers, Architects. Architects, Construction Engineers,….capable, years of experience in both the role of User, Operator (Investor) along with the role of Design Engineer (Consultant) will simultaneously Accompanying customers from the first process to putting the plant into operation and maintenance

4.4 Management – ​​Supervision of construction Construction and equipment installation

The construction and equipment installation phase includes many items such as:

• Workshop: Ensure to minimize the possibility of infection, cross-contamination, easy to clean, against outside intrusion (dust, insects, ..)
• HVAC system with requirements: Temperature, Humidity, Pressure, Air exchange frequency, Cleanliness
• RO water system/Distilled water/wastewater treatment: Compliant with GMP, Pharmacopoeia, product specific requirements during production and testing, etc.
• Pneumatic, Vapor, …: Suitable for the characteristics and usage needs of production and products,..
  Strength of INTRACO E&C is factory construction. The above process not only requires Quality Assurance, Progress, Cost, Construction Safety in accordance with the design documents, but also parallels the preparation of IQ, OQ, and PQ Records.

4.5 Training and practical guidance on WHO GMP standards

Personnel of all departments at the factory unit need to be trained in basic theory of GMP/GLP/GSP, combined with Practice specific jobs of each specific employee to ensure the proper operation of the job. standard

4.6 Initial Documenting/Re-Assessment WHO GMP

The preparation of the application for the first WHO GMP (EU GMP, PIC/S GMP) assessment (or GMP re-assessment) is the final stage of the process of preparing for the plant to be put into operation and application. according to WHO GMP principles and standards (EU GMP, PIC/S GMP)

Application for GMP Assessment (GMP Assessment Report) is a document that covers the entire process, from the preparation stage to the actual activities of the Enterprise in order to prove to the Management Authority that, the Factory Designed, Built, Operated in compliance with GMP/GLP/GSP principles and standards. The GMP assessment dossier will be submitted to the Management Authority (Drug Administration, Department of Animal Health, etc.) to review and decide whether the factory is eligible for GMP assessment or not?