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We provide full service Quality Control / Quality Assurance capabilities. Our quality laboratories provide raw material, packaging component, microbial, chemical, in-process, and finished product testing services to support production operations in compliance with cGMP requirements.
Analytical Services to support production and product development:
- GC/HPLC, Total Organic Carbon, TLC testing
- IR, Colorimeter and UV Spectrophotometer
- Wet chemical analysis
- Method Development and Optimization
- Microbial Testing
- Stability Testing and ICH pharmaceutical storage conditions
Quality Assurances support all production requirements for our customers. We can incorporate customer quality systems into our operations or assist in their development. Quality assurance systems include:
- Incoming, In-process and final product inspections and product release
- Production quality standards and retains
- Specification and master batch record development and management
- Document, Label, and Change Control
- Annual product reviews
- Audits, complaint investigations and corrective actions
We have an extensive validation program including DQ, IQ, OQ, and PQ of process and laboratory equipment and validations of our water system, cleaning protocols, test methods and production process for all pharmaceutical products. We assure that all protocols meet regulatory expectations and current industry standards. A Comprehensive change control program assures that all equipment and process validations are maintained.
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