Quality Systems
Our Quality Systems consist of Quality Control (QC), Quality Assurance (QA), Microbiology and Validation. The integration of all these functional operations ensures compliance at every step of the cGMP and manufacturing process. The Quality System department works closely with manufacturing groups to assure adherence to quality standards in all systems and processes throughout Laureate Pharma’s facilities.
At Laureate we work with clients to ensure that quality agreements are put in place with each client, tailored to the client needs. We write specifications and have them approved by the client for each client-specific raw material, packaging component, in-process material and finished product. We also write Master batch and formulation and fill records, which are approved by the client. The client may perform audits at any time for specific issues and once a year globally.
Quality Assurance Systems
Our Quality Assurance Systems consist of cGMP Documentation System (batch/fill records, standard operating procedures (SOPs), specifications test methods); Audit and Review System (batch records, equipment logs, test records, validation data); Approval and Release System (raw materials, intermediates, final product to client); Vendor Approval System (components and outside testing); cGMP Compliance System (training, in-house audits); Change Management System (approved documents, facilities equipment and processes) and Corrective action and preventive action (CAPA) system (deviations and incidents, corrective/ preventive actions, investigations, remediation plans).
Quality Control and Microbiology Testing
We offer Quality Control and microbiology testing for raw materials, in-process and finished protein, antibody and pharmaceutical products. Our labs are registered with the US Food and Drug Administration (FDA) and licensed by the Drug Enforcement Agency (DEA) and the Nuclear Regulatory Commission. Our analytical testing programs cover biopharmaceuticals, pharmaceuticals and radiopharmaceuticals.
Our Microbiology team conducts environmental monitoring of all clean room areas, and performs speciation tracking and trending data, Water for Injection (WFI) sampling and testing, oversight of outside testing, sterility and microbial limits/bioburden. We also monitor our facility’s nitrogen, oxygen, carbon dioxide, compressed air, clean steam, and reverse osmosis/deionization (RO/DI) water system.
Validation
Our validation program follows Validation Master Plan, and includes installation qualification (IQ) operational qualification (OQ) and performance qualification (PQ) of all critical equipment, revalidation program, customer-specific equipment and process validation and in-house staff supervision of contractors and consultants.
Regulatory Assistance
Laureate’s facility is registered with the FDA, the DEA, state and federal, and the NRC, state and federal. Our team has experience working with the FDA, Canadian and European agencies. Our staff has prepared chemistry, manufacturing, and controls (CMCs) for investigational new drugs (INDs), biologic license applications (BLAs), new drug applications (NDAs) and European dossiers. We provide the CMC and regulatory support by working closely with the client’s regulatory groups and preparing CMC sections for INDs and other regulatory submissions (site DMF reference letter (Type V).
