GMP standards for Pharmaceutical factories

Good Manufacturing Practice (GMP) is a manufacturing practice standard, including general principles, regulations, guidelines for basic content of production conditions; Applicable to establishments producing, processing, packaging food, pharmaceutical products, medical equipment, cosmetics, etc, to ensure the product’s quality and safety.

GMP is a fundamental part of the food safety management system, the basis for developing HACCP systems and ISO 22000 food safety management standards.

Applying the GMP standards also prevents the risk of misbranding, contamination or mixing of manufactured goods.

In the United States, GMP is enforced by the US FDA through the Current Good Manufacturing Practices (CGMP) provisions and covers a wide range of industries such as cosmetics, food, medical devices and prescription drugs. FDA conducts facility inspection in the US to ensure CGMP compliance. Serious violations can often result in product recall as required by the FDA.

In Europe, GMP-EU certification confirms that pharmaceuticals are manufactured from factories quanlity European standards.

In Vietnam, since 1997, the General Department of Standardization, Metrology and Quality has issued a Decision guiding general guidelines on basic contents of GMP applied in food production establishments. Since July 1, 2008, the Ministry of Health has also decided that all manufacturing establishments of western medicines permitted to produce must meet GMP-WHO principles and standards. Currently, the Ministry of Health has circulated a Guideline on Good Manufacturing Practices (GMP) in manufacturing and trading health food (the latest version was issued in July this year, 2019).

In 2010, Vietnam had 4 pharmaceutical factories meeting GMPs standards. By January 2019, 222 companies had met the GMP-WHO principle standard.

Benefits of GMP

GMP is not only required in Vietnam but also has many GMP levels to bring different benefits to pharmaceutical companies:

• Hau Giang Pharmaceutical Company plans to upgrade the factory under the current GPM-PICS standard to GMP-EU to have a competitive advantage in drug procurement and export.
• In Traphaco’s 2018 plan, the company has two goals that are considered to be very ambitious: Registering GMP-EU standards at Vietnam Pharmaceutical Factory and creating a breakthrough in the Southern market. With GMP-EU In addition to confirming that the pharmaceutical products manufactured from Traphaco factory are of European quality standards, equivalent to the world’s leading corporations, this is also a travel ticket for Traphaco to participate more strongly in the market drug procurement (treatment system) next to the pharmacy channel.
• GMP development process is a never-ending process that will develop continuously to improve product quality, enhance the reputation of businesses, protect consumers, so more and more businesses apply and maintain

In addition, the trend of manufacturing management in the coming time of pharmaceutical enterprises is to further promote the digitization in pharmaceutical production and distribution management, in particular, the application of ERP solutions to the pharmaceutical industry. Enterprises control the situation and provide timely and sufficient information to control the situation when making business and production management decisions.

10 basic principles of GMP

Rule 1: Design the factory right from the start

Rule 2: Evaluation process

Rule 3: Write down the procedures and follow the written procedure:

Rule 4: Determine who does what?

Rule 5: Good record keeping

Rule 6: Training and developing employees

Rule 7: Practicing good hygiene

Rule 8: Maintenance of workshops and equipment

Rule 9: Quality design based on the entire product lifecycle

Rule 10: Regular inspection

Productivity and Quality Office