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GLP SERVICES
What is GLP?Why Implement GLP?
Implementation, Training and Coaching
Validation Studies
Internal Audits of Your Quality Systems
Third-Party Audits of Your Supplier's Quality Systems
What is GLP?
Good Laboratory Practices is a set of internationally harmonized regulations, mandated by the Environmental Directorate of the Organization for Economic Cooperation and Development (OECD).
These principles are founded on a proactive philosophy of preventing risk, by testing and assessing chemicals to determine their potential hazards. These evaluations are based on safety test data of sufficient quality, rigor, and reproducibility. They have been developed to promote the quality and validity of test data.
It is a managerial concept covering the organizational process and the conditions under which laboratory studies are planned, performed, monitored, recorded, and reported.
Why Implement GLP?
These principles are required to be followed by test facilities carrying out studies to be submitted to national authorities for the assessment of chemicals relating to the protection of human health and the environment.
These apply to non-clinical safety testing of products such as pharmaceuticals, pesticides, cosmetics, veterinary drugs, food additives, feed additives, and industrial chemicals. These test items are frequently synthetic chemicals, but may also be of natural or biological origin, and in some circumstances, may be living organisms.
These safety studies include work conducted in the laboratory, in greenhouses, and in the field.
Implementation, Training and Coaching
We can:
- conduct an assessment of your present Quality Management System and procedures;
- use our pre-developed plan to perform a "Gap Analysis" to determine the deficiencies within the:
- facility organization and personnel;
- quality assurance programme;
- facilities;
- apparatus;
- physical, chemical, and biological testing systems;
- test and reference items;
- standard operating procedures;
- study plan;
- format and content of the final study report; and
- storage and retention of records and study materials.
- provide a general overview for Management and Staff;
- assist with writing and revising the policies, procedures, validations and forms;
- select and coach personnel involved in the implementation process;
- provide detailed training to individual departments, regarding specific GLP requirements;
- conduct the internal quality audit, and assist with implementing the required corrective actions;
- liaise with the External Auditor;
- be present and provide consultation during the Inspection Audit; and
- perform regular follow-ups, thereafter.
Validation Studies
This is the documented act of demonstrating that any of your critical procedures, processes, equipment, materials, activities, or systems will consistently lead to expected results. We can perform:
- Installation Qualifications;
- Operational Qualifications;
- Performance Qualifications;
- Retrospective Validations; and
- Prospective Validations.
ICS can prepare all of the required documentation and perform the actual work, when requested.
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Internal Audits of Your Quality Systems
ICS can provide an objective and unbiased review, to assess conformance to the regulations, and determine the level of implementation & effectiveness of the quality system requirements. This is done using our extensive checklists, which have evolved and are continually improved over time. We can then identify opportunities for improvement, within the scope of the quality system requirements.
Third-Party Audits of Your Supplier's Quality Systems
ICS can let you know whether your suppliers are meeting their contractual agreements, no matter where they are located throughout the world. These suppliers may include contract manufacturers and/ or testing laboratories.
No matter where your suppliers are located, we can most likely provide these services at less travel expenses. This is due to our network of strategic alliances or subcontracted auditors, or we may also have other clients in the city that your supplier is located.