When it comes to quality assurance and compliance testing for medical devices and pharmaceuticals, two prominent sets of standards govern the procedures and protocols that ensure products meet rigorous health, safety, and quality benchmarks.
These are the United States Pharmacopeia (USP) and the International Organization for Standardization (ISO). Both are critical in their respective domains but serve distinct purposes and differ in their approach and application. Understanding the primary differences between USP and ISO testing is essential for stakeholders to ensure their products not only meet the required standards, but also fulfill the expectations of consumers and regulatory bodies.
What is USP Testing?
The United States Pharmacopeia (USP) is a scientific non-profit organization that establishes standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements. USP testing is predominantly focused on pharmaceuticals and healthcare products, ensuring that they are of the highest quality, safe for consumption, and properly labeled.
Key Characteristics of USP Standards
USP standards are highly specific to the pharmaceutical and healthcare industries. They often involve detailed procedures for testing the chemical composition and physical properties of drug substances and products.
USP guidelines provide protocols for:
Verification of Active Pharmaceutical Ingredients (APIs): Ensuring the identity and strength of the APIs used in drugs.
Assessment of Contaminants and Impurities: Testing for unwanted substances that could affect product safety.
Evaluation of Product Stability: Determining the shelf life and storage conditions for pharmaceuticals.
Determination of Product Storage Requirements: Specifying the conditions under which products must be stored to maintain their efficacy and safety.
USP testing methods are widely accepted in the United States and have a significant influence on regulatory practices and quality control in the pharmaceutical industry.
What is ISO Testing?
The International Organization for Standardization, known as ISO, is an international body composed of representatives from various national standards organizations. ISO establishes standards that provide world-class specifications for products, services, and systems to ensure quality, safety, and efficiency. ISO testing applies to a wide range of industries, including medical devices and pharmaceuticals.
Broad Application of ISO Standards
Unlike USP, ISO standards have a broader scope, applicable to various sectors. ISO testing ensures that materials, products, processes, and services are fit for their purpose and conform to international best practices.
Some well-known ISO standards relevant to medical devices and pharmaceuticals include:
ISO 13485 for Quality Management Systems: Specifically designed for medical device manufacturers, ensuring consistent design, development, production, and delivery of safe and effective medical devices.
ISO 14971 for Risk Management: Providing guidelines for identifying and mitigating risks associated with medical devices.
ISO 10993 for Biological Evaluation of Medical Devices: Establishing standards for testing the biocompatibility of medical devices.
ISO 17025 for Testing and Calibration Laboratories: Enables laboratories to demonstrate that they operate competently and generate valid results.
ISO standards are globally recognized and are instrumental in facilitating international trade by ensuring consistency and quality across nations and industries.
USP vs. ISO Testing: Understanding the Differences
When we dissect the primary differences between USP and ISO testing, several key factors stand out. These include their scope, industry focus, and the nature of the standards they provide.
Scope and Industry Focus
USP standards are specific to the pharmaceutical sector and related fields, while ISO standards have a wider reach, impacting numerous industries, including medical devices and pharmaceuticals. This fundamental distinction shapes the nature of the testing methods and the implementation of the standards.
Testing Methods and Standards
USP testing methods are meticulously designed for the pharmaceutical industry’s unique needs, with a strong emphasis on the ingredients and composition of pharmaceutical products. In contrast, ISO provides a framework that can be adapted to various industries, focusing on the processes and management systems that underpin quality assurance and performance.
Compliance and Recognition
USP compliance is critical within the United States, especially for pharmaceutical products, and USP standards are considered complementary to the regulations enforced by the Food and Drug Administration (FDA). ISO standards, however, are internationally recognized and often serve as a benchmark for companies seeking to enter global markets and demonstrate their commitment to excellence and reliability.
Certification and Accreditation
While USP does not provide certification, companies can demonstrate compliance with USP standards through internal testing and third-party verification. ISO, on the other hand, offers certification through accredited bodies, which can be a powerful marketing tool and a testament to a company’s adherence to international standards.
What testing is included in both standards?
The following list of standardized testing is included in both USP and ISO standards. It is important to know the difference:
Product Sterility: USP <71> or ISO 11737-2
Key Differences: USP <71> describes that the sterility test is applied to substances, preparations, or articles which, according to the Pharmacopeia, are required to be sterile. ISO 11737-2 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with a sterilizing agent and are undergoing validation.
Bioburden: USP <61>, USP <62> or ISO 11737-1
Key Differences: Bioburden in USP standards is also referred to as “microbial limits” and is generally used in testing non-sterile pharmaceuticals. ISO 11737-1 is primarily for medical devices that will be undergoing a sterilization modality.
Endotoxin: USP <85> or ISO 11737-3
Key Differences USP <85> covers specifics for the detection or quantification of endotoxins and has parts that have been harmonized to correspond to the European and/or Japanese Pharmacopoeia. ISO 11737-3 walks through the specifics of the development, validation and routine control of health care products for endotoxin.
How can Canyon Labs help?
Whether you are testing in accordance with ISO or USP standards, Canyon Labs’ ISO 17025 accredited test lab is equipped handle your testing needs. Our test laboratories include microbiology, analytical chemistry, and packaging.
Additionally, we have consulting services can also help navigate the challenging regulatory landscape. Through a partnership with Canyon Labs, feel supported throughout testing, compliance, and regulatory processes. Our team can be a vital, one-stop resource in product development. Visit our website to begin consulting and testing with Canyon Labs.
Conclusion
Understanding the primary differences between USP and ISO testing is essential for businesses in the medical device and pharmaceutical sectors aiming to meet stringent quality and safety standards. While USP testing is tailored to the pharmaceutical industry, ISO testing offers a broader framework for various sectors, including medical devices. Each set of standards plays a crucial role in ensuring that products and services are safe, reliable, and of high quality, which is vital for consumer protection, corporate integrity, and global trade. By choosing the right standards for their needs and committing to rigorous compliance testing, companies can uphold their reputations and contribute to a safer, more dependable market.
Learn how Canyon Labs can be your integrated, one-stop resource when bringing a new product to market. Contact us to begin your partnership and take advantage of our fast, reliable testing and consulting services today!