Pharmaceutical and food and beverage manufacturers are uniquely responsible for offering products that can directly affect human health. As such, businesses are responsible for ensuring their products follow strict quality standards.
In the U.S, the Food and Drug Administration (FDA) is responsible for regulating businesses and, as a result, has outlined and instituted a system of best practices commonly referred to as Good Manufacturing Practices (GMP).
Manufacturers that fall short of these practices put their operations at risk of offering contaminated products to their customers. Failure to live up to the Good Manufacturing Practices can result in massive product recalls or seizures as well as legal trouble in the form of fines, lawsuits, and even jail sentences.
What are Good Manufacturing Practices (GMP)
The GMP system comprises documentation, standard procedures, and processes that manufacturers must adhere to to ensure that their products are fit for safe human consumption.
As the general manufacturing industry has evolved, so have the standard requirements needed to churn out safe, high-quality products. The advent of Pharma 4.0 has seen various kinds of digital solutions like GMP software become more integral to ticking all the boxes as emphasized by the Good Manufacturing Practices system.
Consequently, manufacturers rely on GMP compliance software to adhere to current Good Manufacturing Practices (cGMP) as safety and quality standards evolve.
What does GMP specifically mean for pharmaceutical and food and beverage manufacturers?
Although different areas have different standards and requirements, the core factors underpinning the Good Manufacturing Practices remain consistent.
Quality management involves quality assurance, a set of mechanisms instituted to ensure that the manufacturer’s production practices comply with GMP specifications.
Companies will often implement quality control measures and manage processes using a Quality Management System to ensure that products meet the mark.
Additionally, this GMP entails quality risk management – a system that vets the risks that can significantly affect the quality of the products.
Because of the sensitivity of their products, pharma and food and beverage manufacturers need to ensure their production environments follow specific standards in order to prevent contamination.
Furthermore, these manufacturers should ensure that their facilities are ideal for workers to do their job safely without affecting the product quality moving downstream.
Hygiene and sanitation
As stated just above, product quality for manufacturers in regulated industries needs to be above reproach.
Therefore, it’s prudent for manufacturers to implement various mechanisms to ensure that customers receive unadulterated medicines, supplements, and food products.
High-quality raw materials
Good Manufacturing Practices require manufacturers to consider quality from the beginning of the production process.
Consequently, companies need to ensure that the raw materials that go into their products are of the highest quality available. As such, companies invest in good material sourcing and inventory management practices.
Employees are vital to the success of GMP implementation. After all, they have access to different areas of the production process.
Therefore, manufacturers ensure that all relevant personnel are trained in carrying out their duties with quality realization in mind. That means that companies need to constantly and consistently train employees to adequately and hygienically execute their tasks.
GMP requires evidence of all measures that have gone into ensuring that the operation follows the required manufacturing practices. That being the case, pharmaceutical manufacturers need to maintain comprehensive, detailed documentation.
Additionally, companies should have documents that detail the procedures in place, as well as reports that show all measures taken to rectify quality defects and shortcomings.
These documents’ veracity is underscored by signatures from relevant authorities as well as management personnel responsible for quality and operations.
This involves assessing the implemented GMP practices and evaluating how they have caught on through regular inspections and quality audits. These audits are also an effective way of ascertaining if an organization ticks the boxes set by the relevant regulatory authorities.
Given the complexity of the current manufacturing landscape, continuously and consistently implementing the above can be pretty challenging for a pharma or food & beverage entity.
Enter GMP compliance software…
How GMP software can help streamline compliance
The more traditional methods of adhering to compliance are paper-intensive, making the process more cluttered and ineffective. However, GMP software makes compliance a more achievable process.
Here is how these digital solutions streamline compliance:
Media-rich SOPs: Operating procedures for a simple process can cover several pages in a manual, opening up several points of failure through their verbosity. However, digital SOPs make for more interactive instruction and learning. This provides employees with a clearer picture of how to do things and what to do in case something goes wrong.
Interactive digital employee training: Pharma and food manufacturing are particularly complex undertakings, requiring employees to be extra careful with their operations. As such, it’s vital to train employees properly to minimize quality-undermining mistakes. However, interactive digital training guides workers through relevant processes more effectively than paper instructions or meetings. One of the emerging technologies in this sphere is computer vision, a solution that trains workers as they perform the given task.
Accurate product traceability: Tracing specific products is a vital facet of product quality management. Electronic logbooks make this process easier and more accurate by automatically noting all relevant product information. Additionally, these digital logbooks also include machine and relevant worker data for more comprehensive product information.
- Advanced data analytics: Modern manufacturing operations produce significant data amounts. For instance, electronic batch records continuously and seamlessly glean data from various production line operations. However, without proper analysis, this data is rendered useless with regard to improving quality. GMP software incorporates powerful analytics to sift through the data, providing comprehensive insights into the operation’s quality state.
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