The What and Why of Good Manufacturing Practices

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What are Good Manufacturing Practices?

Good Manufacturing Practices, also known as GMP, defines regulations for continuous production and quality control. These standards cover all parts of the manufacturing process for medical devices, food and beverages, pharmaceuticals, nutritional supplements, and more. The specific regulations differ between industries, but the ultimate goal of GMP remains the same. Consumer safety and ensuring consistent product quality from manufacturers.

Manufacturers have to follow a variety of rules and regulations that can be overwhelming. The quality of the products often depends on these good manufacturing practices

This handy guide will give you an overview of what GMP is, why it is important, what guidelines are in GPM, and how best to incorporate GPM into your day-to-day processes.

Attributes of GMP

GMP is sometimes referred to as CGMP or Current Good Manufacturing Practice. This is because the use of the latest equipment and technologies is imperative to achieve the safety standards set by GMP. Therefore, the equipment should only perform for its intended purpose and should be serviced regularly. This maximizes the safety of workers and the products you manufacture.

Raw Materials: Production materials should be obtained from a trusted supplier and incoming raw materials should be checked regularly for defects. Materials should be stored in clean, air-conditioned rooms to reduce the risk of spoilage.

Personnel: An effective GMP plan requires a team willing and able to adhere to safety standards in order to make the best possible product. All employees, whether in the workshop or not, must be trained in hygiene and safety in order to meet the standards set by GMP.

Validation and Qualification: Devices and systems must be regularly qualified in order to be used as intended and produce high-quality products, and then processes and procedures must be validated to ensure that their results also consistently meet these standards.

Complaint Management: All manufacturers should have a well-designed complaint management system in place that documents complaints, the reasons for violations, and the way in which complaints are handled.

Records: Documentation is prescribed in GMP and is an essential part of effective quality assurance. Traceable activities such as manufacturing and quality control must have appropriate documentation that is easily accessible, understandable, and signed by qualified personnel.

Inspections and Audits: Internal inspections and audits should be carried out regularly to ensure that the facility complies with GMP standards. Inspections must be thoroughly documented. With details such as: what was inspected, when, and which processes or materials need to be improved.

GMP Standards

The GMP standards are set by regulatory authorities to ensure the safety of an end product. These standards are primarily aimed at the pharmaceutical industry, but the principles can easily be carried over to other industries that focus on manufacturing. 

They differ from GMP guidelines because they are more like GMP standards that allow manufacturers to set goals that not only ensure the safety of their customers but also ensure a high-quality product. 

To be in compliance with GMP standards, ensure your manufacturing company is completing the following steps:

 

Compliance Training

Make sure everyone in the company is aware of GMP regulations by providing compliance training and regular retraining. This can be done at the time of hiring, especially if standards change. Employees should be trained in best manufacturing, hygiene, labeling practices, and complaint management. They warn management if there are processes that can be improved in a way that is consistent with GMP standards.

 

Regular Audits and Inspections. 

Consistent audits and inspections simulate a full FDA audit without the risk of penalties if violations are found. Errors can be corrected and corrected immediately, and the causes of these problems can be assessed and addressed.

 

Processes and Equipment Validation

Validation is a documented performance of frequently performed activities on regularly used devices. Including validation in routine GMP, checks ensure that the processes contribute to a high-quality end product. The validation must be carried out from the computer for each task with a risk factor

 

Importance of GMP

Good Manufacturing Practices protect both your manufacturing company and your customers. GMP emphasizes preventive measures that reduce even the smallest risks to your product and ultimately to your buyers. As per GMP standards, you promote an attitude of continuous improvement that ensures your product is of the highest quality.

Integrate quality beyond your traditional product management to ensure good manufacturing practices across your organization. Start your digital journey with KloudPLM. To Schedule a demo, click here.

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