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Overview of GMP Standards and Building GMP Processes through ERP Management System

In the pharmaceutical and food industries, adherence to Good Manufacturing Practice (GMP) standards is an extremely crucial factor in ensuring product quality and safety. But have you ever wondered, "How can we effectively build and manage GMP processes?" This article will provide you with an overview of GMP standards and detailed guidance on integrating GMP processes into an Enterprise Resource Planning (ERP) system.

Let's explore how an ERP system can be a reliable companion in monitoring and complying with GMP standards.

Overview of GMP Standards and Building GMP Processes through ERP Management System

  1. 1. What is GMP Standard?

GMP stands for Good Manufacturing Practice, also known as Good Production Practice. It is a system of principles and procedures aimed at ensuring the quality, safety, and efficiency of various products, including pharmaceuticals, food, cosmetics, and medical devices. Additionally, GMP is applied in other fields such as veterinary drugs, aquaculture, tobacco, organic agriculture, and more. GMP is implemented throughout the entire production process, from raw materials, equipment, personnel, and environment, to the final output.

The history of GMP dates back to 1938 when the United States enacted the Food, Drug, and Cosmetic Act to regulate the quality of pharmaceutical products after an incident where hundreds of people died from using pain relievers containing the toxic substance diethylene glycol. Subsequently, in the 1960s, the World Health Organization (WHO) established basic GMP principles for pharmaceutical products. In 1996, the countries in the ASEAN region adopted the ASEAN GMP standard for pharmaceutical and healthcare product manufacturing.

Currently, GMP requirements have been adopted in various other fields. In agriculture, there is GAP - "Good Agricultural Practice." In the cleaning industry, there is GHP - "Good Hygiene Practice" or GPP - "Good Pharmacy Practice."

  1. 2. Why do Vietnamese manufacturing businesses need to comply with GMP standards?

Vietnamese Manufacturing Businesses Need to Comply with GMP Standards for the Following Reasons:

Firstly, GMP helps businesses improve product quality, minimize risks, and enhance credibility in the market. By adhering to GMP, companies establish a rigorous control system from raw materials to final products, ensuring there is no contamination, errors, or fraud during the production process. Additionally, GMP also aids in cost and resource-saving by reducing waste, damages, and product recalls.

Secondly, GMP facilitates the expansion of export markets and international competitiveness for businesses. Currently, many countries require imported goods to be GMP certified to ensure product quality. Therefore, if Vietnamese businesses have GMP certification, they can easily access demanding markets such as the United States, Europe, Japan, or South Korea.

Thirdly, GMP helps businesses meet legal and societal requirements. Decision No. 3886/2004/QD-BYT issued by the Ministry of Health on drug production and business states that pharmaceutical companies must implement and apply GMP-WHO principles and standards from the effective date of the decision. Moreover, according to Decree, No. 15/2018/ND-CP by the government on food quality management, food manufacturing businesses must comply with GMP/GHP (Good Hygiene Practice) requirements to obtain a food safety certification. Therefore, GMP is not only a technical standard but also a legal obligation and social responsibility for Vietnamese businesses.

  1. 3. How does an ERP Management System help monitor and comply with GMP processes?

An ERP (Enterprise Resource Planning) system is an integrated technological solution that manages various functions of a business, including manufacturing, accounting, sales, inventory, human resources, and strategic management. ERP helps businesses optimize business processes, enhance efficiency, and improve product and service quality while ensuring compliance with industry standards and regulations.

So, how does an ERP Management System help monitor and comply with GMP processes? Let's explore some specific benefits of ERP in supporting GMP:

  • - The ERP software system helps track and control the origin, quantity, and quality of raw materials from the point of receipt in the warehouse to their use in production. It also assists in storing and managing information related to the business's suppliers, distributors, and customers.
  • - The ERP software system aids in planning and coordinating production activities in line with GMP standards. This includes formulating recipes, setting technical specifications, task assignments, and quality control checks and confirmations. ERP also records and tracks any incidents, errors, or complaints during the production process.
  • - The ERP software system generates and maintains reports and documents relevant to GMP, such as inspection records, inventory receipts, product labels, and quality certifications. ERP also ensures the secure storage of these data for easy retrieval when needed.

  1. 4. What are the basic steps to integrate GMP standards into the ERP Management System?

To integrate GMP standards into the ERP Management System, businesses need to follow the following basic steps:

Step 1: Assess the needs and objectives of the business regarding GMP compliance. Businesses should identify legal requirements, market demands, and customer expectations related to GMP standards, as well as the benefits and risks of implementing GMP.

Step 2: Choose an experienced and reputable ERP provider for GMP implementation. Businesses should research the features, functions, and customization capabilities of the ERP system, as well as the support, training, and maintenance services offered by the ERP provider.

Step 3: Design and set up the ERP system according to GMP standards. Businesses need to collaborate with the ERP provider to determine the technical requirements, processes, and data of the ERP system to align with GMP standards. They also need to ensure that the ERP system can communicate and integrate with other systems within the business, such as quality management systems, batch tracking systems, and product inspection systems.

Step 4: Test and validate the ERP system before deployment. Businesses should test the functionality, safety, and efficiency of the ERP system against GMP criteria. They should also review the data, processes, and reports generated by the ERP system to ensure accuracy, completeness, and consistency.

Step 5: Train and educate employees to use the ERP system. Businesses need to train and educate employees on GMP principles and rules, as well as how to use the ERP system effectively and safely.

Step 6: Continuously evaluate and improve the ERP system according to GMP standards. Businesses should monitor and evaluate the effectiveness of the ERP system in complying with GMP standards, using key performance indicators, reports, and feedback. They should also update and improve the ERP system to adapt to changes in GMP standards, market demands, and customer expectations.

In summary, GMP standards are crucial in the pharmaceutical and food industries to ensure product quality and safety. The ERP management system supports effective monitoring and compliance with GMP processes. Integrating GMP standards into ERP requires identifying requirements, customizing the design, training employees, and establishing procedures. Continuous evaluation and improvement are essential to ensure the effectiveness of GMP processes within the ERP system. Besides the pharmaceutical and food industries, GMP and ERP can be applied in other fields to enhance product quality and production efficiency.

Contact us now for a consultation and a free trial of PharmaSoft ERP software. With PharmaSoft, you will have a comprehensive and efficient management system to closely monitor and comply with GMP processes in the manufacturing industry.

EnterSoft Software Solutions Joint Stock Company

Email: info@entersoft.com.vn - kinhdoanh@entersoft.com.vn

Phone: +(84) 28 625.88.511 - Hotline: 0985.200.060

Website: www.entersoft.com.vn

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