ISO 17025 Analytical Laboratory Accreditation Testing
The ISO/IEC 17025:2017 standard sets forth stringent criteria for the competence of bodies operating laboratories that provide services and/or results to demonstrate conformity with regulations. This accreditation ensures that a laboratory is capable of conducting tests and providing calibration services consistently, accurately, and reliably.
Pharmaceutical testing within this context is critical due to regulatory compliance requirements, ensuring product safety, efficacy, and quality. The biopharmaceutical sector, in particular, faces unique challenges related to large-molecule compounds which necessitate specialized analytical techniques beyond traditional small molecule approaches.
The ISO 17025 accreditation for analytical laboratories involved with biopharmaceutical & biosimilar testing involves a comprehensive assessment of the laboratory’s technical capabilities, quality management systems, personnel qualifications, and facilities. This process includes:
- Reviewing documented procedures
- Evaluation of staff qualifications
- Inspection of physical plant and equipment
- Verification of test methods and procedures
- Assessment of calibration practices
- Examination of data management processes
The accreditation process not only ensures that the laboratory meets international standards but also provides assurance to clients, regulatory bodies, and other stakeholders that the results are reliable and valid.
| Parameter | Description |
|---|---|
| Testing Capacity | Range of testing including stability studies, impurity profiling, and degradation pathways analysis for biopharmaceuticals. |
| Method Validation | Demonstration that the analytical method is suitable for its intended purpose. This includes linearity, precision, accuracy, specificity, robustness, and reproducibility. |
| Safety Standards | Incorporation of safety protocols to protect personnel and the environment from hazardous substances used in biopharmaceutical testing. |
| Quality Assurance | Continuous improvement processes ensuring compliance with international standards like ISO/IEC 17025:2017, ICH guidelines, and other sector-specific requirements. |
The laboratory must be capable of performing complex analyses that can handle the variability inherent in biologics. This includes the use of advanced instrumentation such as high-performance liquid chromatography (HPLC), mass spectrometry (MS/MS), and capillary electrophoresis.
Given the critical nature of pharmaceutical testing, compliance with ISO 17025 is paramount for maintaining trust in the biopharmaceutical industry. The accreditation process ensures that laboratories can consistently deliver accurate results, which are essential for regulatory approval, patient safety, and product efficacy.
Scope and Methodology
The scope of ISO 17025 analytical laboratory accreditation testing within the context of biopharmaceutical & biosimilar testing includes:
- Analysis of biologics for impurities, degradation products, and stability over time.
- Determination of active pharmaceutical ingredients (APIs) in formulations.
- Evaluation of drug product quality attributes including purity, potency, and consistency.
- Identification of potential contaminants or impurities that could impact safety or efficacy.
The methodology involves:
- Sample preparation following validated protocols to ensure the integrity of the sample.
- Application of appropriate analytical techniques tailored to the specific molecule being tested.
- Data interpretation and reporting in accordance with regulatory requirements.
- Validation of methods using standard reference materials (SRMs) or international standards like ICH Q6A, Q7A, etc.
The laboratory must be capable of handling complex samples such as monoclonal antibodies, fusion proteins, and gene therapies. These tests require precise control over environmental conditions to prevent any degradation of the sample which could lead to inaccurate results.
Validation studies are conducted using reference materials that meet international standards like those specified in ISO 17025:2017. The laboratory must also be able to demonstrate proficiency through participation in proficiency testing programs recognized by regulatory bodies such as the United States Pharmacopeial Convention (USP) or European Medicines Agency (EMA).
Benefits
- Enhanced Credibility: ISO 17025 accreditation enhances a laboratory's reputation and credibility, making it more attractive to clients.
- Regulatory Compliance: Ensures compliance with international standards for testing biopharmaceuticals, thereby facilitating regulatory approvals.
- Client Trust: Clients can trust the accuracy of test results provided by a laboratory that meets stringent quality and technical criteria.
- Patient Safety: By ensuring accurate and reliable testing, ISO 17025 accreditation contributes to patient safety in biopharmaceuticals.
The benefits extend beyond regulatory compliance. Laboratories accredited under ISO 17025 are better positioned to handle the complexities of biologics testing, which is essential for innovation in the pharmaceutical industry.
Competitive Advantage and Market Impact
- Innovation Leadership: Laboratories with ISO 17025 accreditation can innovate more effectively by ensuring consistent and reliable results from their tests.
- Patient-Centric Focus: By adhering to stringent quality standards, laboratories contribute positively to the development of safe and effective biologics for patients.
- Increased Market Share: The trust that ISO 17025 accreditation brings can lead to increased market share as clients prefer accredited laboratories for their testing needs.
The impact on the pharmaceutical industry is profound. With increasing demand for biologics and biosimilars, labs with this accreditation are better equipped to meet the regulatory requirements of major pharmaceutical companies around the world.
