Celebrating 30 years of cGMP excellence since 1995
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232 - Notes_ First Supplement 02.2015
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233 - Original General Chapter
233 - Second Supplement to USP 38
BSI Onshoring Reshoring Initiative
Commentary to Second Supplement USP 38_ Relative to 232 & 233
Elemental Impurities in Marketed Products - EMA_ CHMP_ QWP_ 109127_ 2015
Elemental Impurities Mandates
GMP News 1-4
Guideline for Elemental Impurities - Q3D Step 4
Guideline for Metal Catalysts or Reagents - EMA_ CHMP_ SWP_ 4446_ 2000
ICH Guideline Q3D on Elemental Impurities - EMA_ CHMP_ ICH_ 353369_ 2013
Inside the Mind of the FDA_ USP 232 - 09.10.2015
Onshoring to Secure Supply Chain for US Drugs 08.18.2020
Overview of BioPharmaceutical Products & Market
Pharma Tech Europe - ICH Implementation_ Challenges_ Opportunities
Q6A Test Procedures and Acceptance Criteria
Q6B Test Procedures and Acceptance Criteria
Q8(R2) Pharmaceutical Development Guidance
Q9 Quality Risk Management
Toxicity Notes
USP 1225 Validation Procedures
USP FAQs 2014 and 2015
USP General Chapter 730
USP Supplement 3_ Correspondence Number C163959
USP-NF General Notice Section 5.60.30
Marketing Materials
Key Documents
Summary List of Products
Sustainability
2025 Highlights
Corporate Sustainability Report
Sustainability Definitions
Sustainability Program Overview
Flyers
BioSpectra History
Contract cGMP Manufacturing
Critical cGMP Ingredient Needs
Critical cGMP Ingredient Needs
GMP Biological Buffers
GMP Bulk Solutions
GMP Facilities
GMP NaOH
GMP Support Package
Premium Pharmaceutical Ingredients
Problems & Solutions
Purified cGMP Biological Buffers
Purified cGMP Fine Chemicals
Quality & Regulatory Program
Spray Dry Technology
White Papers
IPEC Federation EU Risk Assessment Guidelines for Excipients
232 - Notes_ First Supplement 02.2015
232 - Original General Chapter
232 Second Supplement To USP 38
233 - Original General Chapter
233 - Second Supplement to USP 38
BSI Onshoring Reshoring Initiative
Commentary to Second Supplement USP 38_ Relative to 232 & 233
Elemental Impurities in Marketed Products - EMA_ CHMP_ QWP_ 109127_ 2015
Elemental Impurities Mandates
GMP News 1-4
Guideline for Elemental Impurities - Q3D Step 4
Guideline for Metal Catalysts or Reagents - EMA_ CHMP_ SWP_ 4446_ 2000
ICH Guideline Q3D on Elemental Impurities - EMA_ CHMP_ ICH_ 353369_ 2013
Inside the Mind of the FDA_ USP 232 - 09.10.2015
Onshoring to Secure Supply Chain for US Drugs 08.18.2020
Overview of BioPharmaceutical Products & Market
Pharma Tech Europe - ICH Implementation_ Challenges_ Opportunities
Q6A Test Procedures and Acceptance Criteria
Q6B Test Procedures and Acceptance Criteria
Q8(R2) Pharmaceutical Development Guidance
Q9 Quality Risk Management
Toxicity Notes
USP 1225 Validation Procedures
USP FAQs 2014 and 2015
USP General Chapter 730
USP Supplement 3_ Correspondence Number C163959
USP-NF General Notice Section 5.60.30
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Celebrating 30 years of cGMP excellence since 1995
Celebrating 30 years of cGMP excellence since 1995
