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Quality

Quality

The quality of the chemical ingredients, APIs and excipients that make up pharmaceutical and biopharmaceutical products is essential to the overall success of a drug. Spectrum Pharmacy Products has developed the experience, expertise and quality systems to ensure that products will meet FDA or other quality standards.

Spectrum Pharmacy Products has the right chemistry backed by quality control.

Our quality control team of more than 30 chemists and technicians perform over 20,000 tests each year in our ISO 9001-2015 in-house, certified testing facilities in California and New Jersey. This ensures safe ingredients for pharmacy products.

Our New Brunswick, NJ Corporate headquarters and site of Spectrum Pharmacy Products, contains 200,000 sq ft of packaging, laboratory and warehousing space. This facility features CFR 210/211 cGMP biopharma standard packaging capabilities and is FDA registered.

With over 125,000 sq ft of packaging, laboratory and warehousing space, our ISO 9001-2015-certified Gardena, CA facility is also FDA and DEA registered.

Meet the Quality Team

Larry Thomas
Vice President, Quality & Regulatory Affairs

Read Larry's Bio

Larry Thomas is the Vice President of Quality & Regulatory Affairs. He leads the team in delivering Spectrum Chemical’s 50+ year commitment to providing high-quality products. Larry directs all quality activities to ensure that Spectrum meets or exceeds the standards from FDA and other authorities. Larry has 20+ years of experience leading quality teams in nearly all GXP areas, including 15 years in GMP quality systems management, laboratory management, and supporting drug manufacturing. Larry is a Certified Quality Auditor through ASQ and is registered in GLPs and GCPs through the Society of Quality Assurance.

Tom Tyner
EHS Director, Scientific & Technical Excellence

Read Tom's Bio

Tom Tyner has over 40 years of experience in the chemical industry with hands on working knowledge within multiple areas including R&D, Quality Control, Quality Assurance, Hazard Communication, Technical Service, EHS and Regulatory Affairs. He retired after 33 years of service to Spectrum in the position of VP of Quality & Technical Service and has recently rejoined the Spectrum team as Director of EHS.

Tej Parikh
Compliance Manager

Read Tej's Bio

Tej Parikh has 15+ years of regulatory compliance experience working with various federal, state, and local authorities, including FDA, DEA, EPA, CBP, BIS, OSHA, CalEPA and NJ DEP. He is responsible for regulatory licensing and inspections for compliance in our operations. As a regulatory leader, Tej has led the company through multiple inspections and continuous improvement projects to ensure commitment to quality and focus on customer requirements for regulatory information.

Ivan Lopez
QA Manager

Read Ivan's Bio

Ivan Lopez is responsible for the Quality Assurance team at the NJ facility. He is a seasoned Quality Leader with over 18 years of experience across the Medical Device, Food Manufacturing, and Pharmaceutical industries. Ivan possesses in depth knowledge in FDA 21 CFR regulations, as well as ISO & ICH standards. Through his time with Spectrum, he has led multiple Quality functions and continues to drive improvements, cultivating a solid Quality Culture.

Robert Van Zile
QC Lab Manager

Read Robert's Bio

Robert Van Zile has over thirty years of experience managing analytical chemistry and microbiology departments in the pharmaceutical industry. Bob has experience working under a Consent Decree and in successfully remediating removal of decree as part of a Quality Team. Bob brings hands-on leadership and the ability to build teamwork and high performing teams.

James Benson
QC Lab Manager

Read James' Bio

James Benson is responsible for the Quality Control laboratory in our Gardena, CA facility. He brings 10 years of laboratory experience to ensure material is tested to meet various compendial requirements including USP-NF, FCC, EP, BP, and JP. He drives quality improvements to promote a high integrity lab with optimal efficiency.

Tests routinely performed in our quality control laboratories:

Instrumental Analysis

  • Atomic Absorption
  • FTIR
  • Fluorescence
  • Gas Chromatography
  • HPLC/UHPLC
  • ICP/MS (Trace elemental analysis: compliance with USP <232>/<233>)
  • Potentiometric Measurements (pH and ISE)
  • More: Proteomic Imaging, Refractive Index, Rotational Viscosity, Specific and Optical Rotation, UV/Vis Spectroscopy, Melting Point, Karl Fischer Titration

Microbial Testing (Biopharma)

  • Differentiate Bacterial Colonies
  • DNase
  • RNase
  • Protease
  • Endotoxin by LAL
  • Total Plate Count
  • Yeast and Mold
  • Specified Organisms

Wet Chemistry


  • Residue on Ignition
  • Loss on Drying
  • Heavy Metals
  • Iodine Value
  • Residue on Evaporation
  • Colorimetric Analysis
  • Gravimetric Analysis
  • Solvent Extraction Techniques
  • Titrimetry (Acidimetric, Complexometric and Redox)

Scientific Documentation - So Much More than a CofA​

Spectrum offers over 600 professionally prepared dossiers on its USP chemicals available for download. This documentation is essential for pharmaceutical manufacturers, and specific products that require special testing/certification for bioburden, elemental impurities or endotoxins. Spectrum offers more than a dozen standard tests and certifications and can provide custom testing upon request. Providing such documentation on downstream production chemicals and materials used during pilot and scale-up phases mitigates manufacturer’s financial and market risk by avoiding down time, or sourcing issues as a product moves through the development process.

  • Product Specification​
  • Safety Data Sheet​
  • Manufacturing Process Flowchart​
  • Certification of Quality Management Systems​
  • Product BSE/TSE Statement​
  • Product Allergen Statement​
  • Product Aflatoxin Statement​
  • General Label Information​
  • Product Certificate of Analysis Sample​
  • General Lot Numbering System Guidance​
  • Stability/Shelf Life Guidance​
  • Kosher and Halal Statements

Extensive Scientific Documentation and QC Support

Make Spectrum Pharmacy Products part of your Quality Management System

Customer Needs

  • Eliminate unpredictability​
  • Reduce reworks​
  • Speed time to market​
  • Prevent product inconsistency ​
  • Ensure reliable performance​
  • Streamline product onboarding ​
  • Address formulation-related questions​
  • Conduct audits and review audit reports 
Right

QC Program Delivery​

  • Documented process and technical support to address non-conformance​
  • Change control, product specifications management, supply chain transparency ​
  • QA “ticket” process to identify and address documentation or production issues among suppliers​
  • Lead time management  ​
  • Custom packaging

503B Outsourcing Facilities

Spectrum Pharmacy Products is backed by Spectrum Chemical to meet compliance requirements:

• FDA registered and inspected bicoastal cGMP facilities

• Certification to the ISO 9001:2015 standard

• DEA controlled substances (Schedules I-V)

• 1,200+ monograph chemical items

• 500+ in-depth scientific dossiers on monograph chemicals

• 400+ APIs covering more than 40 therapeutic areas

• 250+ top chemical excipients

• Worldwide sourcing capabilities for hard to source monographed chemicals

bioCERTIFIED™ Quality Management System & Chemicals

  • Complete lot analysis including tests for endotoxin, bioburden and elemental impurities
  • Comprehensive regulatory and scientific documentation
  • Change control, batch traceability and supply chain transparency
  • Extensive product breadth and packaging flexibility

Learn More

Quality Matters:  Regulatory Compliance and Auditing​

Spectrum Pharmacy Products makes an ongoing effort to make compliance as easy as possible. Customers seeking to purchase sensitive, regulated or controlled items will be asked to provide appropriate credentials. For some products, we will request additional intended use information to meet regulatory or product stewardship obligations. Please help us to ship your order as soon as possible by providing required information and document expeditiously. 

Spectrum Pharmacy Products hosts audits for customers.  Please contact our Quality Assurance department to arrange an in-house or virtual audit.

Quality Assurance: quality_assurance@spectrumchemical.com

USA / Canada: 1-800-370-6231

Regulatory Compliance and Forms

Learn more

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About Spectrum Pharmacy Products

Spectrum Pharmacy Products leverages our expertise in sourcing, QC testing and packaging of chemicals provided by other manufacturers to meet the needs of organizations in highly regulated industries.  Spectrum Pharmacy Products is a certified women’s business enterprise (WBE).

Spectrum Pharmacy Products is a division of Spectrum Laboratory Products, Inc. and over 200 employees work together across three worldwide locations to offer thousands of chemicals in laboratory, scale-up and bulk quantities.  We also provide supplies, equipment, consumables, and PPE for your pharmacy.

We conduct in-house QC testing by lot to safeguard quality at each of our facilities and provide extensive regulatory and scientific documentation to ensure compliance. We also offer change control, lot traceability and supply chain transparency to eliminate unpredictability. Our products are packaged and stored under cGMP in FDA-registered and inspected facilities.

With our diverse product portfolio and relentless focus on quality, we deliver security of supply to minimize risk and raw material variability, as well as offer highly personalized service and practical consultations to earn your trust and exceed expectations.

 
2023