Quality Assurance & Quality Control
SCD's research and manufacturing team provides technical expertise in microbial technologies, natural fermentation processes and regulatory compliance.
SCD's experts focus on the critical factors that create a "Total Quality System" founded on our customer's needs and expectations. The goals of our quality efforts are based on customer satisfaction and continual quality improvement and all activities are directed toward these objectives. We make quality part of every job and every task, and not an organizational appendix. SCD Probiotics follows the Food Grade current Good Manufacturing Practices (cGMP) Guidelines enforced in the United States by the Food and Drug Administration. GMP guidelines provide a system of processes, procedures and documentation to assure the product produced has the identity, strength, composition, quality and purity that it is represented to possess.
Our Total Quality System
- Production and Process Controls
Our Standard Operating Procedures (SOPs) formalize the quality control system by defining responsibility and authority, providing uniform understanding and producing consistent actions. SOPs are maintained for usage, calibration, maintenance, and cleaning of manufacturing facility, equipment and instrumentation, as well as for raw materials and final product control. For example:
- Master production and control records are reviewed and approved by the Senior Manager, Research and Quality Control.
- Incoming raw materials are reviewed against approved specifications and used on FIFO (first in, first out) basis.
- All production is performed in specifically defined areas to prevent sample contamination and/or mix-ups.
- The instruments and equipment are operated in optimal condition for use and are frequently monitored, evaluated and calibrated.
- Quality Control/Assurance and Laboratory Operations
QC/QA SOPs are established and followed in order to verify and guarantee accurate and consistent production. In order to fulfill QC/QA operations, fermentation Critical Control Points (CCPs) have been developed and established through research. For example, ProBio Food™ primary CCPs include monitoring of fermentation temperature, pH, redox potential, refractive index and optical density microbial counts (i.e. lactic acid bacteria and total plate counts) to ensure product quality and consistency. Certified independent quality assurance laboratories are integrated into the process to provide 3rd party Certificates of Analyses (CoA).
- QC Documentations
Certificate of Analyses (CoA) report quality control data (i.e. pH, microbial counts, etc.) for a particular batch of a product and are used to guarantee that product specifications are met. Products will not be released or sold unless 3rd party test results have been verified and approved. Additional QC documentations that are available include Material Safety Data Sheets (MSDS).
- Warehouse, Distribution, and Post-Distribution Processes
Storage and transportation of finished product are conducted under conditions that protect against physical, chemical and microbial contamination, as well as degradation of the product and its container. Distribution records are maintained and retained for at least one year beyond the expiration of shelf-life. Written SOPs for complaints, product returns, product salvaging, defect action level and reserve samples are established and followed.
- Records Retention
In recording information our production team adheres to three general principles: 1) permanence, 2) traceability and 3) security. Regulatory inspections are kept on file with documented corrective actions, if necessary. Data is recorded, stored, and controlled to prevent it from being destroyed, stolen, or tampered with. Production reports are complete, accurate, and reviewed. We encourage tours of our facilities to demonstrate our quality initiatives, the extensive capabilities of our staff and our emphasis on exceeding customer needs.