Good Manufacturing Practices (GMP): the secret to uniting quality and compliance

Good Manufacturing Practices (also known as GMP) is a set off guidelines, rules, and procedures that companies need to follow to ensure the quality and safety of the products/services offered. They are applied in companies from different sectors; Among the main ones are the areas of food, medicines and cosmetics.

GMP can be applied in numerous areas and activities in a corporation. Some examples are the personal hygiene of employees, equipment maintenance, product quality control, documentation of all stages of the production process, and transportation of inputs.

Read on and find out more about good manufacturing practices, how to follow them, the benefits they bring, and the dangers of neglecting this care.

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What is Good Manufacturing Practices (GMP)?

Ensuring the maintenance of the quality of the products/services offered, as well as the well-being of the people involved in the production process, is a mission of companies in various areas. However, this poses a major challenge, especially in highly regulated markets such as the pharmaceutical and food industries.

To remedy this difficulty, Good Manufacturing Practices (GMP) emerged. The World Health Organization (WHO) was one of the first entities to create guidelines for GMP, through the publication of recommendations for the sector in 1969. Since then, they have been adopted by several countries over the years, always seeking to standardize manufacturing processes, minimize risks, avoid errors, and strengthen quality and compliance.

Today, several entities and segments have their respective Good Manufacturing Practices. In many cases, government agencies are responsible for creating them, such as Anvisa in Brazil, the FDA in the US, and the European Medicines Agency (EMA) and the European Food Safety Authority (EFSA) in Europe. In addition, several certifications — such as some from the International Organization for Standardization (ISO) — require companies to use GMP to be certified.

Regardless of their origin and to which entity they are linked, all Good Manufacturing Practices have some basic objectives: to boost quality, minimize risks, avoid errors/accidents, and standardize activities/processes. Therefore, GMP needs to be part of your Quality Management System (QMS).

To ensure that these goals are achieved, good practice in relation to GMP is to have a manual (which you will find out how to create later). It will contain the guidelines, standards and recommendations relevant to the market, area or sector involved. The manual also usually contains some basic guidelines.

The Good Manufacturing Practice guidelines

There are some basic Good Manufacturing Practices (GMP) guidelines that are essential to ensure the quality and safety of products. Of course, they can vary according to the activity, the sector of activity and the product/service involved, but below you know 11 of the most common guidelines:

Personal Hygiene: Talks about the care of employees in maintaining strict hygiene. It addresses items such as appropriate uniforms, frequent hand washing, and use of personal protective equipment, among others.

Facility Hygiene: Deals with the cleanliness of production areas. It lists good cleaning and organization practices, with regular cleaning and disinfection procedures.

Quality Control: It encompasses all procedures that protect the quality of inputs, ingredients, and products. It also addresses regular tests and inspections aimed at assessing this quality.

Documentation and Records: It is also essential to keep detailed records of all production processes. Remember to do this throughout the chain, involving suppliers, the treatment of raw materials to the distribution of products to the final consumer.

Employee Training: GMP also addresses measures so that employees have adequate training not only in their operational activities but also in Good Manufacturing Practices themselves.

Equipment Maintenance: This guideline indicates carrying out regular maintenance of equipment. This is essential to ensure their correct functioning and thus avoid contamination/failures.

Pest Control: In addition to cleaning the environment, equipment, and employee hygiene, it is also necessary to have measures in place to prevent and control possible pests in the facility.

Adequate Storage: GMP does not only talk about actual production. They also address the storage of raw materials and products, ensuring that they are in proper condition. This prevents deterioration, contamination or undue alterations.

Standard Operating Procedures (SOP): It is recommended to develop and follow standardized procedures for all production operations.

Traceability: This item addresses the ability to trace all products from the origin of raw materials to the final consumer.

Internal Audits: To ascertain that everything is working as expected, it is necessary to conduct regular internal audits. They verify the operation’s compliance with GMP and thus help identify areas for improvement.

See also: Free Food Safety Checklist

What are the advantages of adopting Good Manufacturing Practices?

And even with so much work, implementing Good Manufacturing Practices is still worth the effort. After all, as you have already seen, this care protects the quality of products/services, safeguards the health of employees, and safeguards your company’s reputation.

But not only that, there are many other advantages of adopting GMP practices – almost as many as there are variations and additions to these guidelines. For you to know the main ones, we have prepared a list below.

Product Quality Improvement: Good practices ensure that products are manufactured according to the most consistent and demanded quality standards in the market. This increases consumer confidence.

Reduction of Contamination: Implementing GMP minimizes any risks of cross-contamination and other types of contamination/alteration in ingredients, inputs, and products. This increases the safety (and quality) of what is manufactured.

Regulatory Compliance: By taking care of the environment, raw materials, actions, and employees involved in manufacturing something, a company is closer to complying with legal and regulatory requirements. Thus, not only does it avoid fines and sanctions, but it also gains the trust of consumers.

Increased Operational Efficiency: GMP optimizes all manufacturing processes. This reduces waste, minimizes errors, and optimizes resource consumption. As a result, this entire process becomes more effective and profitable.

Improvement of the Company’s Reputation: This reflects the other care and optimizations that Good Manufacturing Practices bring. After all, by adopting them, your company demonstrates its commitment to quality, safety, and compliance. In this way, it strengthens its image in the market and creates a good reputation with all stakeholders.

Employee Safety: Care in the manufacture of products also protects those who are responsible for it. In other words, the implementation of GMP promotes a safer and healthier work environment, which reduces the risk of accidents and/or occupational diseases.

Ease of Employee Training: By complying with this GMP guideline, the company adds well-documented procedures that facilitate the training and adaptation of new employees.

Increased Shelf Life of Products: Having good practices that incorporate preventive measures helps to extend the shelf life of the items produced. In this way, a company can count on goods in full quality conditions for longer. This reduces costs, optimizes investment and increases the company’s profitability.

Cost Reduction: Another benefit that manifests itself as the sum of a series of care. As you have already noticed, GMP causes waste reduction and optimizes operational efficiency; All of this results in cost savings and resource optimization for the company.

The impacts of not using GMP

If, on the one hand, having GMP helps your company in all these aspects above, on the other hand, not having this type of care can seriously impact your company – and not in a positive way.

Not following Good Manufacturing Practices (GMP) can affect the quality of products, harm the health of employees, and even impact the company’s presence in the market irreversibly.

Learn about some of these impacts below and see why you can’t leave GMP aside.

Consumer Health Risks: Without proper care, products can end up contaminated or of poor quality. As a result, you can end up bringing to consumers items that can cause illness and adverse reactions, becoming a real public health problem.

Legal Penalties: By not complying with GMP, a company also ends up having non-compliance with the standards/legislation of regulatory bodies. This can lead to fines, sanctions, and even the closure of the establishment in extreme cases.

Loss of Consumer Confidence: Lack of compliance with Good Manufacturing Practices also results in a loss of consumer confidence. When the market perceives that a company does not pay attention to safety, quality, and compliance, the brand’s reputation is affected – and, consequently, customer loyalty disappears.

Product Rejection: Another risk of not adopting GMP is ending up manufacturing products that do not meet the quality standards required by partners, customers, resellers, or distributors. This generates waste of input, and financial losses, and even wears out the relationship with these parties.

Increased Costs: Using quality guidelines and recommendations reduces costs; not having this type of care generates waste, rework, and even product recalls, which increases operating costs.

Impact on Competitiveness: Companies that do not follow GMP tend to lose market share precisely to competitors who pay attention to this type of care.

Legal Problems and Lawsuits: It’s not just regulators that can take legal action against companies that don’t take care of their manufacturing process. Consumers affected by low-quality products can also sue the company, resulting in legal costs and damage to its image.

Production Interruptions: In serious cases of failures, errors, or contamination in manufacturing processes, it is possible that there will even be production interruptions (whether partial or total). As a result, the ability to meet market demand and keep the operation running profitably is greatly reduced.

How to create a Good Manufacturing Practices (GMP) manual?

For you to be able to reap all the fruits of Good Manufacturing Practices and prevent any of these negative effects of their absence from affecting your company, it is essential to create a GMP manual.

In practice, it is a detailed document (whether physical or virtual) that lists all the procedures and guidelines necessary to ensure the quality and safety of manufactured products.

Keep in mind that this is not a fixed or universal model. A good GMP manual considers all the specifics of a company. Among them is the market in which it operates, products/services offered, manufacturing activities and processes, sectors involved in this, type of devices used in manufacturing, inputs and suppliers.

GMP Manual Structure Template

But this also does not mean that there are not some items considered more popular, which can be implemented and adapted in different company profiles. Below we have prepared a list with a structure tip for your Good Manufacturing Practices manual, check it out:

Introduction: Describe what the purpose of the manual is and its importance.

Company Description: Bring information about the company. Include data such as location, organizational structure, products manufactured, and more.

Facilities and Equipment: Details of how the maintenance and cleaning of facilities and equipment is carried out.

Quality Control: Describe the procedures adopted to ensure the quality of the products, including inspections and tests, for example.

Personal and Facility Hygiene: List what the hygiene rules are for employees and what the facility cleaning procedures are.

Pest Control: Include here what are the measures to prevent and control pests.

Storage and Transportation: This item describes the guidelines and practices for the safe storage and transportation of products.

Documentation and Records: Show what types of GMP-related records and documentation will be kept for internal control. Also include the procedures adopted to keep all this up-to-date and easy to access.

Employee Training: Describe how they are carried out and what are the objectives of the training and qualification programs made available to employees involved in the manufacturing process.

Standard Operating Procedures (SOPs): Include a detailed description of the operating procedures involved in the manufacturing steps.

Tips for creating a good GMP manual

In addition to a standard structure to guide your manual, it’s important to keep an eye out for more tips that help you create a cohesive and complete document. In this way, it is easier to have a manual that actually helps to implement and improve Good Manufacturing Practices in your company.

Know the regulations: Familiarize yourself with the regulations, certifications, and other guidelines/standards relevant to your industry. This will ensure that your manual complies with the requirements.

Involve the whole team: Do not build the Good Manufacturing Practices manual alone. Include employees in this process to gain valuable insights into daily processes. This also helps to identify areas that need improvement.

Be detailed: Thoroughly describe each step of the manufacturing process, from receiving the inputs to distributing the products for sale. Also include the Standard Operating Procedures (SOPs) for each activity mentioned in the manual.

Documentation and Records: Keep detailed records of all operations and manufacturing steps. Include facility maintenance and sanitation, pest control, employee health monitoring, and more. At this point, following the structure model we showed you above is of great help.

Ongoing training: Ensure that all employees are regularly trained in the practices outlined in the handbook. This helps maintain compliance and the quality of processes. Also, review training periodically to ensure that it is up to date with the recommendations and requirements of the moment.

Regular Update: Review and update the manual periodically to reflect changes in relevant processes, regulations, or technologies. An annual review may already be enough to implement continuous improvement measures.

Internal Audits: Finally, perform internal audits to verify that everything described in the manual is being put into practice and, more than that, that it is following GMP. This process helps to identify areas for improvement and needs to be rigorously documented, showing the results achieved and the corrective actions taken when necessary.

Following these steps will help you create a comprehensive and effective manual. With it, you will be able to ensure that your company follows industry regulations, and, in addition, you will maintain the high standards of quality and safety required by regulatory entities and the market itself.

Conclusion

When implementing Good Manufacturing Practices (GMP), your company adopts essential care for any organization that wants to ensure the quality and safety of its products.

This not only ensures compliance with regulations, but also improves operational efficiency and reduces costs associated with waste and rework.

And to make this process even more effective, agile, and secure, you can also count on robust risk management software. With this solution, your company can monitor and control all aspects of the manufacturing process, from the reception of raw materials to the distribution of products.

In addition, it is possible to identify and mitigate potential problems before they affect production. This results in safer, higher-quality products, strengthening consumer trust and brand reputation.

In an increasingly competitive market, investing in technology to support GMP is a strategic step that can differentiate your company and ensure its long-term success.

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