Inclusion of an accreditation on a Storefront is information provided for comparison purposes. Pipeline Bio does not verify, endorse, or guarantee the regulatory standing of any Provider. Members should confirm current certification directly with the Provider.
Good practice (GxP) frameworks
| Term | Definition |
|---|---|
| Good Clinical Laboratory Practice (GCLP) compliance | Applies Good Laboratory Practice (GLP) principles to the analysis of samples from clinical trials while ensuring the objectives of Good Clinical Practice (GCP) are maintained, so that laboratory data are reliable, accurate, auditable, and suitable for clinical research purposes. |
| Good Clinical Practice (GCP) compliance | Adherence to internationally recognised ethical and scientific quality standards for designing, conducting, and reporting clinical trials involving human subjects. |
| Good Distribution Practice (GDP) compliance | Ensures that pharmaceutical products are consistently stored, transported, and handled under proper conditions to maintain quality and integrity. |
| Good Laboratory Practice (GLP) compliance | A quality framework governing the planning, performance, monitoring, and reporting of non-clinical safety studies to ensure reliability and integrity of data. |
| Good Manufacturing Practice (GMP) compliance | A regulatory system ensuring that pharmaceutical and biological products are produced and controlled according to quality standards suitable for their intended use. |
| Good Pharmacovigilance Practice (GVP) compliance | Guidelines for monitoring the safety of medicines, managing risks, and ensuring that adverse events are properly reported and investigated. |
| Good Warehouse Practice (GWP) compliance | Standards ensuring that materials and products are stored and distributed in ways that maintain quality, traceability, and compliance with regulatory requirements. |
Research ethics and animal welfare
| Term | Definition |
|---|---|
| AAALAC International accreditation | Accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC International), which recognises organisations that meet high standards for animal welfare and ethical research practices. |
| Australian code for the care and use of animals for scientific purposes | National guidelines outlining ethical standards for the humane care and use of animals in research and teaching within Australia. |
| Institutional Review Board (IRB) or Independent Ethics Committee (IEC) | Committees responsible for reviewing and approving research involving humans to ensure ethical standards and participant protection are maintained. |
| International Society for Pharmacoepidemiology (ISPE) guidelines | Guidance promoting high-quality pharmacoepidemiological research and responsible use of medicines through standardised methodologies. |
Laboratory, testing, and manufacturing standards
| Term | Definition |
|---|---|
| ISO 9001 compliance | Compliance with the ISO 9001 standard for quality management systems, ensuring consistent products and services that meet customer and regulatory requirements. |
| ISO 13485 compliance | A quality management standard specific to medical devices, ensuring regulatory compliance and consistent product safety and performance. |
| ISO 14555 compliance | Defines quality requirements for welding processes, including design, production, and inspection procedures for metallic materials. |
| ISO 14644 compliance | Specifies air cleanliness standards for cleanrooms and controlled environments used in research, manufacturing, and healthcare settings. |
| ISO 15189 compliance | Sets quality and competence requirements for medical laboratories, ensuring accuracy and reliability of diagnostic testing. |
| ISO 17025 compliance | Specifies general requirements for the competence of testing and calibration laboratories, ensuring reliable analytical results. |
| ISO 17034 compliance | Defines standards for producing certified reference materials used to ensure accuracy and traceability in testing and calibration. |
| ISO 19011 compliance | Provides guidelines for auditing management systems, including quality, environmental, and information security audits. |
| ISO 20387 compliance | Establishes quality and competence requirements for biobanking, ensuring biological materials are collected, stored, and distributed reliably. |
Information security and privacy
| Term | Definition |
|---|---|
| AICPA Trust Services Criteria compliance | Adherence to the American Institute of Certified Public Accountants (AICPA) Trust Services Criteria, covering security, availability, processing integrity, confidentiality, and privacy in data management systems. |
| Australian/New Zealand Standard AS/NZS 27001 | A regional implementation of ISO 27001, specifying requirements for establishing, implementing, maintaining, and improving an information security management system. |
| COBIT — Control Objectives for Information and Related Technologies | A governance framework for managing and optimising IT processes, risk, and compliance in organisations. |
| Information Security Forum (ISF) Standards of Good Practice | A globally recognised set of best-practice principles for managing information risk and security within organisations. |
| ISO 27001 compliance | Defines requirements for establishing and maintaining an information security management system to protect sensitive organisational data. |
| ISO 27701 compliance | An extension of ISO 27001 focused on privacy information management, aligning with global data protection standards such as GDPR. |
| NIST Special Publication 800-53 compliance | A U.S. framework providing a catalogue of security and privacy controls for federal information systems and organisations handling sensitive data. |
| SOC 2 Type 1 compliance | An attestation report evaluating an organisation’s system controls for security, availability, and privacy at a specific point in time. |
| SOC 2 Type 2 compliance | A more comprehensive report assessing the operational effectiveness of security and data protection controls over an extended period. |
Environmental, safety, and continuity
| Term | Definition |
|---|---|
| ISO 14001 compliance | Specifies requirements for an effective environmental management system, helping organisations reduce environmental impact and comply with regulations. |
| ISO 14064 compliance | Provides standards for quantifying, monitoring, and reporting greenhouse gas emissions and removals to support environmental accountability. |
| ISO 22301 compliance | Specifies requirements for business continuity management systems, helping organisations prepare for and recover from disruptions. |
| ISO 45001 compliance | Specifies requirements for occupational health and safety management systems to improve workplace safety and reduce risks. |
| ISO 50001 compliance | Standard for energy management systems that provides a framework for organisations to establish, implement, maintain, and continually improve systematic energy use and efficiency, helping reduce energy consumption, costs, and greenhouse gas emissions. |
Australian accreditations and registrations
| Term | Definition |
|---|---|
| National Association of Testing Authorities (NATA) accreditation | Recognition by NATA that a laboratory, inspection body, or calibration facility meets Australian and international standards of technical competence. |
| Office of the Gene Technology Regulator (OGTR) compliance | Operating in accordance with Australia’s gene technology laws, including holding the required licences and controls for work involving genetically modified organisms. |
| Registered provider (R&D Tax Incentive) | Refers to an organisation formally recognised as an eligible provider of R&D services under Australia’s Research and Development Tax Incentive program. |
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