What is GMP

A system to ensure and control that products are being elaborated under the appropriate quality standards.

With the globalized trade and the consumer’s growing awareness of products’ safety and effectiveness, it is of utmost importance to recognize that the continuous improvement of the quality of products as a goal is secondary to the maintenance of the GMP. The main goal is to produce high-quality, safe products that will be effective and not harmful to the patient/consumer.

GMP is the abbreviation for “Good Manufacturing Practice” which is a concept described in regulations, created and designed to minimize all the risks involved in a product life cycle to ensure the quality and safety of said product. 

The GMP regulations tend to vary from country to country. Still, its essence is always the same. A regulatory framework that ensures that consumers only receive products of uncompromisingly high quality and safety. 

The GMPs contain all the minimum requirements for the methods, facilities, and controls used in the manufacturing, processing, packing, and distribution of a product. It looks at every aspect of the manufacturing process to safeguard against potential risks that can prove detrimental to products and consumers, like cross-contamination, mislabeling and adulteration.

Who creates and issues the GMP regulations?

  • GOVERNMENTS
  • MINISTRIES
  • INTERNATIONAL ORGANIZATIONS

The GMP regulations can take various forms such as:

  • LAWS
  • REGULATIONS
  • GUIDES

Why is GMP important?

For the life sciences industry, GMPs are a legal obligation; in other words, something they must comply with to remain operative. 

The true importance of the GMP is that through these strict regulations, we can create a safe, high-quality, and sanitary environment to produce safe and high-quality products, which turns out to be a significant factor. Even the slightest error in a product, drug, or food product can have devastating consequences for the consumer and society. 

Maintaining and being GMP compliant can help facilities earn and maintain the trust of consumers, who want to know that the products they buy are manufactured in safe and well-regulated environments.

What are the 10 principles of GMP?

Like any other quality system, the GMPs have basic principles employed to meet the stated goal of producing safe and high-quality products. Here are 10 of these principles: 

1 – QUALITY SYSTEM: 

The first principle consists of the implantation of a quality system. This is because a good quality system will help develop and ensure quality procedures in various product life cycle stages, such as manufacturing and product testing. This is key to ensuring that products are consistently produced and controlled according to the quality standards appropriate to their intended use and as required by the Marketing Authorization or product specification. 

The quality system is a specific implementation of quality concepts, standards, methodologies, and tools to achieve quality-related goals. Continuous improvement of the Quality Management System (including processes and products) is significant in GMP, usually utilizing the PDCA cycle (plan-do-check-act)

2 – ORGANIZATION AND PERSONNEL:

The second principle focuses on the idea that to achieve a high-quality product or process, we must have a culture of quality. Therefore, everyone who works within a GMP facility should be well-trained and qualified.

They should be aware of the various GMP principles and receive continual training to maintain and improve their job skills. 

3 – BUILDINGS, FACILITIES, AND EQUIPMENT:

Another key component to producing high-quality products is having adequate and sanitary facilities. 

Adequate means that the facilities should be in a suitable location, free from the risk of any contamination. Additionally, the facility should be designed to help minimize the risk of potential errors in operations and be easy to clean and maintain.

Because the design of a facility can affect compliance, it is vital to have a good understanding of the requirements before embarking on any cGMP project. To design the facilities each step of the manufacturing process should be considered, including the process flow, material flow, personnel flow/circulation, automated processes, facility operations, etc.

Similar to the facilities’ requirements, any equipment within the facility must be located, designed, constructed, adapted, and maintained to suit the operations to be carried out. Their layout and design must aim to minimize the risk of errors and permit effective cleaning and maintenance to avoid cross-contamination, build-up of dust or dirt, and, in general, any potential adverse effect on the quality of products.

4 – VALIDATION AND QUALIFICATION:

GMPs require that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. 

Any changes to the facilities, equipment, utilities, and processes that may affect the product’s quality should be formally documented and the impact on the validated status or control strategy assessed. 

This validation consists of collecting data throughout a process to establish evidence that a said process can consistently deliver quality products.

Qualification is the action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and lead to the expected results. Qualification is part of the validation, but the individual qualification steps alone do not constitute process validation.

5 – DOCUMENTATION:

Good documentation constitutes an essential part of any quality management system and is key to operating in compliance with the GMP requirements. 

The main objective of the system of documentation must be to establish, control, monitor, and record all activities that directly or indirectly impact all aspects of the quality of products. Therefore, everything should be documented in a clear, legible manner. This documentation may exist in various forms, including paper-based, electronic or photographic media. 

GMP documentation ensures the quality and traceability of manufacturing processes, maintenance, and quality checks. A good documentation system will help build a detailed picture of what a manufacturing function has done in the past and what it is doing now and, thus, it provides a basis for planning what to do in the future.

6 – PRODUCTION AND PROCESS CONTROLS:

Production operations must follow clearly defined procedures to obtain products of the requisite quality and be in accordance with the relevant manufacturing and marketing authorizations. All handling of materials and products, such as receipt and quarantine, sampling, storage, labeling, dispensing, processing, packaging, and distribution, should be done in accordance with written procedures or instructions. There should be quality control points to ensure all non-conforming manufactured material gets pulled out of the process.

7 – QUALITY CONTROL:

Quality Control is concerned with sampling, specifications, and testing, as well as the organization, documentation, and release procedures. These ensure that the necessary and relevant tests are carried out and that materials are not released for use nor products released for sale or supply until their quality has been judged satisfactory. 

Establishing good quality control procedures helps ensure that the product that is released to the market meets the predefined criteria and specifications, including the absence of contaminants, among others. GMP quality control can also help mitigate the need for recalls or lawsuits that can arise should a faulty or defective product make it to market.

8 – OUTSOURCED ACTIVITIES:

This principle takes into consideration the idea that to produce a high quality product, one must input quality materials. Therefore, any outsourced activity should be appropriately defined, agreed and controlled to avoid misunderstandings that could result in a product or operation of unsatisfactory quality. This includes purchasing, receipt, storage, and use of raw materials, maintenance activities, warehouse activities, and more.

There must be a written Contract between the Contract Giver and the Contract Acceptor that clearly establishes each party’s duties. And every supplier and its product or service has to be qualified.