Review, revise and create Standard Operating Procedures (SOPS) for your facility's compounding operations.
Assess and evaluate correspondence from regulatory bodies such as 483 or warning letter issued by the FDA and assist your establishment in resolving the issues.
Pharmacist consultation services in compounding operations to 503A’s with disciplinary action.
Provide training to your personnel in Sterile & Non-Sterile compounding within your facility customized to your Compounded product portfolio and ‘USP Category’ of sterile drugs in Sterile Compounding.
Consulting Services in launching and operating a Compounding facility.
Pharmacist consulting services to Ambulatory Surgical Centers.
Providesupplier and third party testing labs verification services tocompounding facilities.
Root Cause analysis in cases of deviations and out of specification outcomes and develop a corrective and preventative control plan.
Measurement of the effectiveness of the corrective and preventative and control plan.
Track and analyze performance metrics and trends. Review findings with management.
Quality Management
Assessment of maturity of Quality management program, perform an in depth gap analysis and develop a risk evaluation and management strategy.
Develop a CGMP and USP compliant quality management program for your establishment.
Provide consultation both virtually and within your facility, on key elements of a sound CGMP compliant quality program customized to your business model.
Provide ongoing Quality assurance and Quality Control services .
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