Laboratory Testing Regulations: GMP vs. GLP
Do you ask yourself before consuming any packaged food or medicine if they are safe for your health? As the average consumer, we might not always question the safety of what we use or eat. That’s because we trust the Food and Drug Administration (FDA) to ensure quality standards for labs and manufacturers producing healthcare and edible products.
The Food and Drug Administration (FDA) has proposed good manufacturing practice (GMP) regulations and good laboratory practice (GLP) regulations for the protection of public health. These practices help ensure high-quality standards in laboratories and industries during their testing and manufacturing processes.
In addition to the people executing the procedures, the lab quality assurance (or quality control) personnel also have essential roles in GMP and GLP.
As much as GMP and GLP sound similar, there are many differences between these compliances, and confusing the two can lead to serious issues for labs or even require retesting products for quality assurance.
This article will explore GMP and GLP regulations and the key differences between these two certifications.
Excedr works closely with research laboratories operating within GMP and GLP regulations. If this sounds like you, lease the cutting-edge lab equipment you need to continue meeting and exceeding those regulations.
What is GMP?
Good manufacturing practice (GMP) regulations were first introduced and enforced in 1938 by the U.S. Food and Drug Administration (FDA), under the authority of the Federal Food, Drug, and Cosmetic Act. Sometimes, it’s also referred to as “current good manufacturing practices” (cGMP). “Current” reminds manufacturers to comply with the systems and technologies that are up to date and follow the regulatory standards.
What does GMP do? What is it for?
GMP regulations contain some best practices for industries to help ensure the safety, quality, and efficacy of food, drugs, medical devices, and cosmetics. They enable companies and labs to minimize or eliminate instances of contamination, mixups, and errors.
GMP addresses issues related to record-keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. It protects customers from buying medicines and foods that may cause adverse effects on their health or harm them in any way.
When is it applied?
GMP compliances are required during the batch/lot release (or lot conformance), manufacturing and testing, and medical product marketing phases. Furthermore, the testing phase of components used in clinical trials (active pharmaceutical products, critical excipients), testing of stability, process validation, and other supporting activities must also follow GMP regulations.
The regulations are not applied to areas where safety assessments are not a concern for discovery, in vitro studies, screening, and basic research studies.
Benefits of a GMP certification
- Cost savings: GMP reduces the operating cost by enhancing the efficiencies of quality control processes and reducing the penalties due to non-compliance.
- Increased consumer confidence: With GMP certifications, organizations instill more trust and confidence in their consumers because of the safety of their manufacturing processes and products.
- Improved production safety: When products are manufactured using the right methods and in the right conditions as proposed in GMP guidelines, it reduces many risks associated with the product quality and safety.
- Competitive advantage in the market: Since GMP increases production efficiency, reduces manufacturing errors, and increases product quality, the reputation of the GMP-compliant company boosts at the international market. This increase in reputation can provide an edge over competitors.
How do you get a GMP certification?
Below are the general steps to get the GMP certification:
- Find an accrediting body and fill out their respective application form for certification by providing all the necessary details and essential data.
- Prepare management, including the quality control unit, and review all written procedures.
- Search for gaps in your current system. Look for any non-conformities in your processes according to the given guidelines by the regulatory authorities.
- Create your implementation project plan to focus on the identified gaps. This will help to set timelines for priority work and will streamline any other workflows.
- Document all the calibration, testing, and manufacturing procedures of your organization.
- Conduct an internal audit to check if all the requirements meeting compliance standards are maintained.
- A final audit will be conducted by an inspector who will verify all documentation, standard operating procedures (SOPs), and the rest of the information provided by your lab. If all GMP standards are found to be followed and maintained, the certificate of GMP compliance will be awarded.
What is GLP?
According to the World Health Organization (WHO), good laboratory practices (GLP) are defined as a “quality system concerned with the organizational process and the conditions under which nonclinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported.”
What does GLP do? What is it for?
GLP provides tools and resources to ensure the high standard management of nonclinical laboratory studies. It assures the quality, reliability, and integrity of studies, the reporting of verifiable conclusions, and data traceability.
GLP promotes data integrity, quality, and validity generated during testing. It protects the public from any fraudulent health practices.
When is it applied?
GLP regulations are applied during nonclinical laboratory safety studies, supporting research and marketing of biocompatibility, toxicology, pharmacology, and other medical products.
However, it doesn’t apply to the manufacturing and testing of medical devices (except design controls), some investigational drug products, and biologics in clinical trials. Further, it’s important to note that clinical studies involving humans are governed by good clinical practices (GCPs), the Declaration of Helsinki, and other regulations designed to protect human participants, not GLP.
Benefits of a GLP certification
- Document trail: GLP assists in creating a document trail that provides traceability for all measurements and data.
- Improved laboratory reputation: The compliance is designed to enhance the quality of products manufactured by labs and manufacturers. A GLP certificate demonstrates the organization’s credibility, thus increasing its laboratory reputation in the market and among its customers.
- Reduced time to market: GLP compliance prevents or reduces the need for re-work and time spent on non-revenue investigations. Thus, GLP fastens the launch of its products to the market with assured safety.
- Accurate and quick results: The perfectly designed GLP principles enable labs and manufacturers to reduce errors, mistakes, or confusion during experiments, leading to producing quality data in the first attempt.
How do you get a GLP certification?
Labs and manufacturers must abide by the following steps to earn a GLP certification:
- Train your staff and assign specific responsibilities to testing facility management personnel, study directors (single point of contact of the whole study), quality assurance personnel, quality assurance units, and archivists.
- Write standard operating procedures (SOPs) for content, layout, and protocol and report formats.
- Search for and analyze the gaps between your organization’s standards and compliance and prepare a checklist.
- Design your approach to project implementation and fill in the gap(s) found in the earlier step.
- Complete all documentation and check for the qualification of the systems.
- Define rules for receipt, identification, handling and storage of all test items, reagents, and reference items. Additionally, design rules for the handling, quarantine, and husbandry of all test systems.
- Conduct an internal audit to verify all the documents and quality control steps in order to validate the reported data. Try to identify any remaining non-conformities before the arrival of the regulatory authorities.
- If there are zero gaps between the organization and GLP standards, the authority allows you to declare GLP compliance in your study reports.
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Get High-Quality Equipment Needed for GMP and GLP with Excedr
GMP and GLP are federal regulations imposed by the FDA for compliance in the stages of design, testing, manufacturing, and the distribution of healthcare products. They ensure proper protocols and process validation for producing replicable results and adhering to industry standards.
GMP deals with the verification and validation of product manufacturing before products hit the market. On the other hand, GLP regulations are concerned about standard procedures, methods, and working conditions in nonclinical studies.
These regulations, however, require the maintenance of equipment used in the processes. This can be tough while also focusing on research studies, budgeting, and related tasks.
Excedr is here to help.
Excedr offers a customized leasing solution to procure equipment at an affordable rate. Explore equipment ranging from analytical, life sciences and biotech, high-tech microscopes, spectrometers, and much more.
Our services include repair, maintenance coverage, and technical training and validation for all equipment.
Excedr is a way for many labs to overcome financial burdens, save cash for more critical business areas, and improve operational capacity.