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Manufacturers are usually subjected to a diverse variety of regulations typically established by international and regional bodies. Failure to comply can result in the loss of authorization and licensing, which could seriously damage business prospects. However, regulatory alignment between different regions is not consistent, meaning there is a disparity in quality and standards from one country to the next.
Good manufacturing practices (GMP) are a series of conventional standards put in place by various regulators globally, intending to set minimum benchmark of quality assurance and control (QA/QC) in key markets. This includes pharmaceuticals, medical devices, dietary supplements, and food and beverages. These regulations and standards apply to both commercial and clinical production facilities.
Manufacturers that comply with GMP regulations by setting an equivalent standard of validation and production can consistently deliver high-grade goods in each batch - but what do GMP regulations really cover?
Main Guiding Principles of GMP Regulations
GMP regulations are an extensive set of guidelines for business practices, which places the importance of product quality before everything else. Virtually every single aspect of production that can affect the quality of goods delivered to consumers is covered by these regulations: from the personal hygiene of staff to the raw materials used in manufacturing. The broad scope of such standards can initially appear to be daunting, however, they are often segmented into several key components:
- Premises: Factories, storage facilities, etc., must be situated in risk-free environments when considering contamination, and ease-of-operations should be taken into account when designing particular structures.
- Processes: Ensuring careful attention is paid to QA/QC is a vital component of GMP regulations. Therefore, mandating robust sampling, specification, and testing of both incoming materials and outgoing finished products is part of true commitment towards high-quality.
- Personnel: GMP regulations are a series of standards that need to be applied by people with the proper training and qualifications, which is why personnel forms the basis of every GMP system.
- Instrumentation: Instrumentation is maintained in a calibrated or validated state to ensure accurate and precise results are consistently obtained.
- Records: Excellent documentation is crucial to any QA process, and is a prerequisite for assuring compliance with GMP regulations.
While this list is not exhaustive of all the major points covered by GMP regulations, it should serve as a concise overview of their scale.
Applications Covered by GMP Regulations
As indicated, GMP regulations are particularly relevant and essential to a key set of markets that directly impact human health. For instance, the US Food and Drug Administration (FDA) manages the GMP standards of food contact material manufacturers, ensuring that all materials used in the manufacturing of food packaging are fit for purpose as food and beverage containers. Medical devices, pharmaceutical production, and relevant supply chains are also subject to GMP regulations.
Jordi Labs & GMP Regulations
Jordi Labs has a great deal of experience as an analytical testing services provider. With immediate access to a broad range of technologies, Jordi offers industry-leading testing services for regulatory compliance and QA/QC standards that also adhere to internal GMP practices. If you would like to learn more about Jordi’s commitment to GMP regulations, simply contact a member of the team today.
This information has been sourced, reviewed and adapted from materials provided by Jordi Labs.
For more information on this source, please visit Jordi Labs.