Manufacturing Quality Systems
The Xcellerex management team spent years operating manufacturing facilities in the pharmaceutical and biotechnology industries and brings a deep appreciation and understanding for the importance of robust quality systems.
The Xcellerex Quality group designs quality into our manufacturing products, systems and technology and supports our manufacturing services to ensure the quality, safety and efficacy of all your products. We focus detailed attention on scientifically sound manufacturing and testing, regulatory compliance, domestic and applicable international compliance requirements, project management, and seamless client communication. Through the application of innovative technologies and equipment, and fostering a culture of continuous improvement, we build high quality and robustness into everything we do.
GMP Compliance
Xcellerex applies current good manufacturing practices, as described in appropriate regulatory directives and guidelines (US 21CFR and FDA, EU and WHO), to the manufacturing process.
Our compliance system integrates facility design, personnel qualification and training, manufacturing controls, materials specifications and inventory controls, quality control, system performance criteria, validation, quality assurance, and document controls.
Quality Assurance
Quality Assurance (QA) responsibilities include: document control, product release, employee cGMP training, quality audits, review and approval of internal cGMP procedures, protocols and reports, Corrective Action and Preventive Action (CAPA), and version and change control management.
Xcellerex employs an electronic Documentation Management System (eDMS), which features the option of allowing clients to view their documents remotely via portal access. GMP documentation managed electronically includes: standard operating procedures (SOPs), specifications, production and testing records, validation documentation, investigation, corrective action and audit reports, and change control documentation.
Optional electronic batch records enhance compliance by minimizing potential for errors in data capture and enabling expedited batch record review and product release.
All Xcellerex employees involved in GMP operations receive initial cGMP training when they are hired and annual training updates. This training emphasizes the responsibility of each employee to ensure the Quality of your products. Job and product specific training is provided as needed. Training is documented in training files maintained and reviewed by QA.
CAPA and Change Control systems are issued, managed, tracked, dispositioned and trended by Quality Assurance.
Validation
Process and assay qualification requirements are assessed initially during the technology transfer stage of the project. As your product progresses through the various stages of development from pre-clinical to commercial manufacturing, validation requirements are reviewed and expanded as necessary to meet phase appropriate standards.
Master Validation Plans are developed to integrate the entire effort and ensure alignment with your needs.
Equipment is subjected to installation, operational and performance qualifications, including incorporation into the calibration and maintenance program.
Validations and qualifications are conducted using pre-approved protocols that define the acceptance criteria; the data are summarized in reports. Protocols and reports are approved by QA.
Quality Control and Analytical Development
Quality control (QC) is critical for ensuring the quality, safety and efficacy of your products.
The QC/AD group offers a complete range of analytical services to support product development from initial preclinical stages through product commercialization. We combine in-house laboratory work with outsourcing of selected tests to provide a complete analytical package that meets your needs.
QC collaborates closely with Analytical Development during method development, transfer and validation.
QC performs raw materials testing and release, in-process testing, release testing and stability testing per ICH guidelines.
QC manages water system analysis and the environmental monitoring program which includes regular monitoring of total particulates and assessment of viable airborne and surface contamination.
Analytical Development responsibilities include
- Specifications development
- Establishment of reference standards
- Product characterization and comparability assessment.
- Specialized analytical support for process development and manufacturing
- Implementing technologies for real-time process monitoring in line with the process Analytical Technology (PAT) initiative.
Regulatory
We continually monitor regulatory agencies world-wide to provide you with the most up to date testing and manufacturing strategies. We work with you throughout the project to:
Develop regulatory strategies
Answer regulatory questions
Prepare CMC sections of regulatory submissions
Prepare and maintain Drug Master Files
Assist with meetings with regulatory agencies
are developed, manufactured & commercialized.
