What is GMP – 10 Principles of GMP ?
Good Manufacturing Practices (GMP)
Nature is the primary source of food materials consumed by humans. Not all foods provided by nature
are 100% safe during the period of harvesting. Processing is necessary for those food materials which
helps to eliminate the negative components from these materials and make them safe for consumption.
Based on the nature of food and the processing processes, it is determined whether the food is edible or
not. Not only the processing stages, post processing stages such as storage, transportation and
distribution also plays a crucial role in maintaining the safety of the food materials.
Minimum standards must be followed while completing the processing of food products. Nowadays,
modern food processing industries are operating on a very large scale. How many of them are operating
in compliance with the standards, this is a primary issue of concern.
Let’s talk about the herbal based food materials. It is found that the industries that process herbal food
products basically process the substances found in nature according to their needs. The food products
processed and produced by them finally reach the consumers. It is important to complete the cycle in
such a way that the quality of natural food products is not degraded or minimally degraded.
The products produced from this way should not affect the health of consumers in any way. For this
reason, manufacturers of herbal products and food supplements must necessarily follow ‘Good
Manufacturing Practices’ i.e. ‘GMP’. Food products produced by adopting good production processes are
and should be safe and wholesome. Such foods are considered best for consumption as they are safe
and of good quality.
In today’s world, the production and sale/distribution of modern medicinal materials is done by
following good manufacturing practices. GMP is and should be applied not only in the context of
pharmaceutical materials but also in the production process of various other types of daily consumables
food materials.
Good manufacturing practice is a part of ‘quality assurance’, which ensures that products are
consistently manufactured with controlled standards to appropriate final quality. Maintaining quality
from production to end consumption is good manufacturing practice. GMP is a combination of
production and management practices to ensure that food products meet the needs and expectations of
consumers being under certain standards. Consumers undoubtedly benefit from good manufacturing
practice as they are quality manufacturing processes in themselves.
Principles of GMP
Generally speaking, the basic principle of good manufacturing practice is that food should be clean and
safe to consume. This also means that the environment around the food should be clean and healthy.
It is said that ‘Proactive Measures for Food Quality and Safety’ is the basic principle of GMP. This is the
concept of ‘prescriptive regulation’ introduced by the Food and Drug Administration (FDA) in 1970. The
FDA describes it as the ‘minimum sanitary and processing requirements for food manufacturers’.
What is GMP for?
The basic objectives of Good Manufacturing Practices i.e. GMP can be summarized as follows:
• To produce clean and safe food.
• Helping to protect human health by minimizing the risks that may occur from food.
• Maximize the use of food.
• Adopting reliable and trustworthy production processes, etc.
Basic requirements of GMP
• All production processes are clearly defined and capable of achieving desired end products.
• All resources and facilities required for the basic requirements of good manufacturing practice
are provided; which can be mentioned as follows:
– Properly trained staff;
– appropriate tools and services;
– correct ingredients, containers and labels;
– approved procedures (including cleaning procedures);
– suitable storage and transportation;
•Operators are trained to perform the procedures correctly.
GMP Basics
Food handler
A person who handles directly packaged foods, food equipment and utensils or surfaces that come into
contact with food. S/he should have a good knowledge of food hygiene requirements.
Food hygiene
It is a concept in which the intended use (preparation or consumption) of food does not cause any harm
to the consumer.
Food Safety Risks
Biological, chemical or physical factors that can be harmful to health when exposed to food.
Quality and quality control
Quality refer to attributes of a product or service that fulfill certain needs. Quality control is a system of
maintaining standards in prepared food products by testing samples based on certain standards.
Contaminants
Any biological or chemical agent, extraneous matter or other substance unintentionally mixed with food
may impair food safety or suitability.
Label
“Label” means any description or indication written, printed or engraved on the container or cover of
any foodstuff placed for sale or being transported.
Batch and Batch Number
Batch: Materials prepared by using certain raw materials, packaging materials or products in a single
process to achieve uniformity. Materials produced in certain quantity at certain time.
Batch Number: A unique combination of numbers or letters that identifies the batch on the label.
Production
Various processes used in the preparation of a product. Production is the collective form of all activities
including entry of raw materials, processing, packaging, re-packaging etc.
Certification
According to the principles of GMP, it is verified that a procedure, process, equipment, material, activity
or system actually produces the expected result. This is a mandatory process for good production.
10 Principles of GMP
- Written Procedure: What to do and how to do, it should be clearly written.
- Following Procedure: When producing food items, the written procedures should be followed.
- Documentation: Write what you do, do what you write. Documentation is the act of writing and
documenting what is done in the production process. - Validating: It should be checked whether the work has been done as stated or not.
- Facilities and Equipment: Ensuring adequacy, convenience, efficiency and proper functioning.
- Maintenance: Proactive and Reactive service and maintenance of materials and equipment.
- Job Competence: The experience, knowledge, quality, goals, performance and skills of the people
involved in the work. - Ensuring environment free from pollution/contaminants: Biological, chemical or physical agents
should not be allowed to enter the food, food contact surface and environment where processing is
done. - Quality control
- Audit: Compliance and non-compliance.
Summary
There should not be any kind of weakness in quality while producing and distributing any food material.
A clean and hygienic environment should be created in the production area (including the laboratory
and storage area). The design of the production area, the principles of operation and the environment
should be controlled so that no objection arises in the quality.
Production processes must be clearly defined, verified and controlled. Instructions and procedures
should be written in clear and understandable language. Proper training should be provided to the
operators regarding production and control as per written/approved procedures.
Production and quality control records should be maintained according to properly defined procedures.
Records should be properly protected. Production processes should be modified as needed. Records of production (including distribution) should be kept in an easily accessible manner, which make it easy to trace the entire batch.
Complaints and complaints received about products that have gone to the market should be heard and addressed. Appropriate steps should be taken to prevent such problems from reoccurring by properly identifying their causes. Sufficient and continuous discussion, and communication should be done on related issues that may affect production and quality.
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