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Excipients

BioSpectra’s Excipients are US manufactured in our two facilities located in Bangor and Stroudsburg, Pennsylvania. All of our Excipients are cGMP manufactured in accordance with ICH Q7 guidelines or PQG IPEC GMP Guide using qualified equipment and utilities,validated processes and a traceable supply chain. An Excipient manufactured at BioSpectra has the following characteristics:

Key Compliance Attributes of BioSpectra’s Grades
Bio Excipient Grade
ICH Q7 Compliant Manufactured
Suitable for Research and Diagnostic
Yes
Each Batch 100% Analyzed
Yes
Management of Change
Yes
Validated Analytical Methods
Yes
Compendial Testing
Yes
Trace Metals Analyzed
Yes
Two Year Stability
Yes
BioSpectra Supply Chain Audit Trail
Yes
Product Origin Statement
Yes
Customer Quality Audits
Yes
Customized Additional Specifications
Yes
Multi-Compendial Testing
Yes
Enzyme Tested
Yes
Validated Manufacturing Process
Yes
US Manufactured at BioSpectra
Yes
IPEC cGMP Compliant Manufactured
Yes
Suitable for use as Excipient
Yes
Microbial / Endotoxin Tested
Yes
Manufactured in FDA Registered Facility
Available
Customized Manufacturing Schedule
Available
Custom Regulatory Packet
Available
Accelerated Stability
Available
Type IV Drug Master File
Available
Video Conference access to BioSpectra Sites
Available
Complete access to Product Traceability
Available
Access to Supply Chain Information
Yes
ICH Q7 Qualified Utilities
Yes
ICH Q7 Compliant Manufactured
Yes
Suitable for use as Active Ingredient
No
Suitable for use in a Sterile Application
No
Type II Drug Master File
No
Available indicates an attribute or level of compliance which is granted based on mutual contractual understanding and typically requires special pricing.