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BioSpectra quality systems

Quality Systems

As an originator of compliance in the Excipient biological buffer industry, the BioSpectra team understands the industry’s evolving needs in quality and regulatory compliance. Customers are comfortable knowing the largest and most successful BioPharm companies in the world have used BioSpectra materials for more than 20 years. Adding BioSpectra products to pharmaceutical processes supports chemistries with the very best materials, manufactured under the most stringent and tested quality systems.


BioSpectra has created a quality system that meets the highest quality and regulatory standards. This system consists of many facets:


Supplier Management

BioSpectra’s supplier management program requires the inspection and approved testing of each incoming raw material. These ensure that the identity, quality and purity of each product is met before being introduced into our facility. BioSpectra’s Quality System maintains the integrity of the supply chain, guaranteeing the compliance, safety, security, traceability and quality of the manufacturing, storage and shipment of each raw material.


Drug Master File

A Drug Master File is a submission to the FDA of information regarding the manufacturing, controls and chemistry of a product. This permits the FDA to review the product information in support of a third party submission. BioSpectra has created DMFs for select products to support customers in their FDA product submissions. For more information please contact the Customer Service Department.


Quality System

BioSpectra has created a Quality System in accordance with cGMP guidelines. The BioSpectra Quality System enables responsibilities to the environment, to employee safety, and to long-term industry growth. This Quality System ensures BioSpectra products are manufactured and controlled through validations and qualifications in accordance with cGMP guidelines. BioSpectra’s Quality System offers the highest level of traceability to ensure the most trusted and reliable supply.


FDA Inspected cGMP facility

BioSpectra manufactures excipients in the Stroudsburg, PA facility, the FDA has periodically inspected the facility against cGMP guidelines. The most recent inspection was conducted in August, 2010, and no Form 483 was issued. BioSpectra is continuously inspected against cGMP guidelines by many different customers, and is proud to state that the compliance has been validated during each audit.

BioSpectra’s API Manufacturing Facility in Bangor, PA is an FDA registered and inspected facility. The most recent inspection was conducted in January of 2016 and no Form 483 was issued.