Q. What level of compliance is offered for each product?
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A. The level of compliance within BioSpectra is held to meet the Q7A guidelines as established through the International Conference on Harmonization. Although, ICH Q7A is a guidance for Good Manufacturing Practices for Active Pharmaceutical Ingredients BioSpectra manufactures excipients under the same level of cGMPs as APIs. |
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Q. Are products manufactured in a GMP facility?
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A. All BioSpectra products are manufactured in a cGMP environment. The facilities management, staff training, environmental monitoring, equipment usage, laboratory testing and processes are all controlled under ICH Q7A guidelines. |
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Q. What are the specifications for each product?
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A. Click on link below to view specifications for each product.
Tromethamine U.S.P.
Urea U.S.P.
Tris HCl
Guanidine HCl
Ammonium Sulfate |
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Q. What is the shelf life or retest date for each product?
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A. All products are given a 2 year retest date. However, stability testing and data for each of our products is available and has been monitored through a 3 year cycle. |
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Q. What is the country of origin of the product? |
A. United States of America |
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Q. Could you provide a TSE/BSE certificate? |
A. A TSE/BSE certificate is available for each BioSpectra product. TSE/BSE certificates are also available for all raw materials used in BioSpectra processes. |
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Q. Are any products derived from animal origin? |
A. BioSpectra does not produce any products derived from animal origin. Please see product chemistry page for more information regarding the derivation of each product. |
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Q. Do you offer validations for each of your products and processes? |
A. All processes are validated in accordance with cGMP guidelines as established through ICH-Q7A. For more information regarding the validation of any of BioSpectra products please contact the quality department. |
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Q. Are samples available for each product?
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A. Samples are. Please contact the BioSpectra sales and service department at for more information. |
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Q. How long has your company been in business? |
A. BioSpectra has been a Pennsylvania Corporation since September 15, 1995. In March of 1996 the manufacturing facility in Sciota, PA was opened becoming the site of the first cGMP manufactured Urea, Tromethamine, Tris HCl, Guanidine Hydrochloride, Ammonium Sulfate and Guanidine Thiocyanate. In 2001 BioSpectra opened its facility in Stroudsburg, PA where all current manufacturing takes place.
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Q. What is the average lot size for each of your products? |
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Product |
Lot Size |
Urea U.S.P.
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3,000 kg min./ 24,000 kg max.
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Tromethamine U.S.P.
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3,000 kg +/- 10 %
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Tris HCl
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3,000 kg +/- 10 %
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Guanidine HCl
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1,500 kg +/- 10 %
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Guanidine HCl 6M |
8,000 L min. / 20,000L max. |
Ammonium Sulfate |
750 kg +/- 10 % |
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Q. What is the expected lead time for one lot of each of your products? |
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A. The lead time for each of the BioSpectra, products are listed below. |
Product |
Lead Time |
Urea U.S.P.
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4 Weeks |
Tromethamine U.S.P. |
4 Weeks |
Tris HCl
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4 Weeks |
Guanidine HCl
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4 Weeks |
Guanidine HCl 6M |
4-6 Weeks |
Ammonium Sulfate |
4 Weeks |
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Q. How can I receive more information about your products? |
A.. Please contact BioSpectra by phone at 570-476-2710 or email using our contact page. |
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Q. How can I speak directly to a quality representative? |
A. A quality representative is available to you at any time during normal business hours (8:00am-5:00pm EST). Please contact a representative by phone at 570-476-2710 or email using our contact page. |
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