An Integrated, End-to-End Quality Control
Our Pharmaceutical Quality System is aligned with the principles of ICH Q10 and built upon strict compliance with cGMP. It spans the full product lifecycle — from new product evaluation, through commercial supply, to discontinuation — and integrates every functional element of our organization into a single quality framework. The system is designed to scale with our business, to remain responsive to evolving regulatory expectations, and above all to protect the patients who receive our products.
An Independent Quality Unit with Defined Authority and Clear Responsibilities
SCA Pharmaceuticals’ Quality Unit holds the authority to create, maintain, monitor, and continuously improve the Pharmaceutical Quality System. Specific responsibilities include:
- Ensuring that procedural and analytical controls are established, executed, and verified throughout compounding operations
- Ensuring that procedures and specifications are scientifically appropriate and consistently followed
- Approving or rejecting incoming materials, in-process materials, and finished compounded products
- Reviewing production records, investigating discrepancies, and determining the disposition of affected product
- Granting final release of finished compounded product for distribution
The Quality Unit’s authority is structural, documented, and exercised without external influence.
Core Elements of Our PQS
Supplier and Material Management
Supplier and material quality are managed at the source. SCA Pharmaceuticals operates a formal Supplier Management program that includes initial qualification, on-site or remote audits, material risk assessment, and ongoing performance review. We treat suppliers as extensions of our quality system and provide structured feedback to drive shared improvement.
Process and Product Quality Monitoring
We conduct formal Annual Product Reviews (APRs) on each commercial product. APRs evaluate manufacturing data, analytical and microbiological results, deviation and complaint history, change history, and stability performance to identify trends and opportunities for improvement. The output of each APR feeds directly into our continuous improvement program.
Corrective and Preventive Action (CAPA)
Our CAPA system manages the lifecycle of corrective and preventive action arising from deviation investigations, out-of-specification results, complaints, adverse events, internal and external audits, regulatory inspections, product and process monitoring, and Management Review. Root cause analysis is rigorous and structured; corrective and preventive actions are verified for effectiveness before closure.
Change Management
A robust change management system governs all additions or changes to validated facilities, equipment, processes, analytical methods, and quality system documentation. Each change is risk-assessed for potential impact on product quality, validation status, regulatory commitments, and patient safety before approval. Implementation is verified and, where required, post-implementation effectiveness is monitored.
Management Review
Senior leadership demonstrates its commitment to the PQS through formal Management Review. On a defined cadence, the leadership team reviews PQS metrics, the outputs of product and process reviews, the status of the continuous improvement program, the effectiveness of CAPA, and the overall health of the quality system. Management Review outcomes are documented and translated into action.
Knowledge Management
Knowledge generated through development, validation, manufacturing, and post-market experience is captured, retained, and made available across the organization. Knowledge Management ensures that lessons from one batch, one investigation, or one product are systematically applied to all.
Proactive Continuous Improvement
A dedicated Continuous Improvement team within the Quality organization advances the maturity of our PQS through proactive, data-driven initiatives that anticipate issues rather than respond to them. The team partners across functions to surface opportunities for variability reduction, process simplification, and patient-safety enhancement, and it owns initiatives through implementation and effectiveness verification.
Environmental Controls
SCA Pharmaceuticals’ cleanrooms are continuously monitored for differential pressure, temperature, and relative humidity through automated systems with alarm capability. Excursions are detected in real time. Compounding is interrupted until conditions are restored to specification. Drug storage areas, incubators, and refrigeration are similarly monitored through validated automated systems with continuous oversight.
Electronic Quality Management System
We operate our PQS through MasterControl®, a validated electronic quality management platform. MasterControl provides the document control, training management, and investigation infrastructure that enable consistent, auditable execution of our quality processes.
Functional modules currently in production include:
- Training
- Document Management
- Deviation Investigations
- Out-of-Specification Investigations
- Change Control
- Corrective and Preventive Action
- Customer Complaints
- Environmental Excursions
- Internal Audits
- External Supplier Audits
- Supplier Complaints
The electronic platform enforces workflow, retains complete audit trails, and supports our data integrity commitments under ALCOA+ principles.