QUALITY DEVELOPMENT SERVICES
QDS – The Quality Development Services team leads the evaluation, development and implementation of Best Compliance Practices™ and support for other daily essential Quality Assurance, Quality Control and Regulatory operations to customers. Support extends to a variety of business types throughout the Food, Dietary Supplement, Cosmetic and Homeopathic industries inclusive of Ingredient Manufacturers, Finished Product Manufacturers, Warehousing/Distribution Companies, Direct Response Companies and Retailers.
QDS has highly trained and qualified members providing onsite or remote support for outsourced QA/QC services to clients needing dedicated part-time, temporary or transitional support in these areas. Additionally, the team provides internal support to RGS as needed, allowing for efficient redundancies to time sensitive or compliance-critical programs, including GMP Facility Auditing, Vendor Qualification(s), USDA Permit Submissions/Management, Certificates of Free Sales, FDA Inspection or Warning Letters and much more.
The types of services include the following:
• Specifications Development/Review – Ingredients and Finished Products
• Formulation Reviews
• SOP Development/Review – For Own-label Marketers, Own-label Distributors, Manufacturers, Distributors and Retailers
• GMP Production Facility Auditing
• Laboratory Facility Audits
• Testing and Stability Protocol Development/reviews
• Quality System Optimization
• Outsourced QA or QC support
Quality Control and Quality Assurance
•Protocol generation testing of novel raw materials
•Protocol review for qualification and/or testing of raw materials
•Microbiological equipment evaluation
•Microbiological equipment qualification (Generation of IQ/OQ/PQ documents)
•Review of SOP for QC Microbiology, QC Chemistry, and Quality Systems
•Data review and/or approval
•Technical document generation – trend reports, directions for use, SOP, regulatory submission sections
•QC Laboratory and QA System audits
•Conduct full Out of Specification or Non-Conformance Report (NCR) investigations and issue associated reports
•Trend OOS or NCR data
•Establishing quality metrics (turnaround time, on-time completion, error rate, etc)
•Starting a new laboratory? We can help design, equip, staff and establish all written procedures.