Inherent in every aspect of successfully developing and launching GMP products, is compliance with industry regulations and standards. This is true throughout the entire development-commercialization cycle. It applies not only to manufacturers, but also their suppliers, vendors and contract service providers.
Where appropriate, these organizations need to define the impact the following system-based variables have on their products and services and implement the required controls to ensure that service or product standards are consistently met.
- Raw Materials, Components & Supplies
- Manufacturing Systems
- Packaging & Labeling Systems
- Facilities, Utilities, & Equipment
- Laboratory Controls, Test Methods & Analytical Systems
- Quality Control & Quality Assurance Systems
At Roberts Pharmaceutical Consulting, we regularly work with both domestic and international regulatory systems and we are highly experienced at evaluating and implementing suitable systems-based controls to ensure consistent service or product quality.
With respect to Clinical & Commercial Drug Substances, Drug Products, Raw Materials & APIs, Components, and Service Providers; we provide the following systems-based services:
MATERIALS & WAREHOUSING SYSTEMS:
- Audit & Qualify Raw Material, API, and Component Suppliers
- Audit & Qualify 3rd Party Warehousing & Distribution Service Providers
- Develop and Implement Material Specifications & Acceptance Criteria
- Establish Appropriate Storage Conditions to Prevent Degradation
- Validate Warehouses and Specialized Environmental Chambers
- Develop Material Receiving & Inventory Management Systems Based Upon FIFO Methodologies.
MANUFACTURING SYSTEMS:
- Audit & Qualify 3rd Party Formulations & Process Development Service Providers & Manufacturers
- Provide Formulations & Process Development Project Management Services for Multiple Dosage Forms
- Manage Scale-up, Technology Transfer and Process Validation
- Assist with Chemistry, Manufacturing & Controls Regulatory Filings
PACKAGING & LABELING SYSTEMS:
- Audit & Qualify 3rd Party Clinical & Commercial Packagers, Label Providers, and Component Suppliers
- Assist with Package Design and Component Selection
- Manage Clinical and Commercial Packaging Activities
- Manage Stability Trial Activities for Diverse Packaging Configurations
- Assist with Chemistry, Manufacturing & Controls Regulatory Filings
FACILITIES, UTILITIES AND EQUIPMENT SYSTEMS:
- Audit & Qualify 3rd Party Service Providers for Preventive Maintenance, Calibration, Pest Control, Security, & Site Qualification
- Provide GMP Training to 3rd Party Service Providers
- Develop and Implement PM, Calibration, and Qualification Programs
- Manage the Preparation & Execution of Installation / Operational / Performance Qualification Protocols
- Assist with Facility, Utility & Equipment Design and Layout, and Equipment Selection and Qualification
LABORATORY CONTROL SYSTEMS:
- Audit & Qualify 3rd Party Analytical Testing Facilities
- Audit & Qualify 3rd Party Service Providers for Preventive Maintenance & Calibration
- Assist in Cleaning Validation Programs
- Develop Test Protocols & Acceptance Criteria
QUALITY CONTROL & QUALITY ASSURANCE SYSTEMS:
- Provide GMP Training to Employees and Service Providers
- GMP Auditing of Suppliers, CMOs, CROs, Laboratories, Vendors
- Develop and Set-up Incoming & In-Process Material Inspection Programs
- Perform Trend Analysis on Finished Product Specifications
- SOP Development
- Set-up Documentation & Records Control Systems
- Review and Approve GMP Documentation: Batch Documentation, Test Methods & Reports, Protocols, Service Reports, etc
- Conduct Quality-related Investigations
- Set-up and Execute CAPA Remediation Activities
- Provide Virtual QA Services
If you would like further information on the Quality Assurance Services provided by Roberts Pharmaceutical Consulting, please call 610-361-9541 or email info@pharmleader.com.
