OTC Testing Services
Certified Laboratories helps manufacturers of over-the-counter (OTC) drug products verify product safety and quality by providing fast, flexible laboratory testing with precision and accuracy. Our ISO 17025-accredited and FDA-registered OTC testing labs can test your components, in-process materials, and finished OTC drug products to confirm your products meet your specifications. We’re a single-source provider to OTC manufacturers and distributors, offering a broad range of services that includes microbiology, chemistry, in-package stability testing, and regulatory consulting.
Regulatory Compliance through OTC Product Testing and Analysis
FDA requirements for OTC product testing are defined in OTC Monographs and in FDA’s current Good Manufacturing Practices (cGMP) regulations:
21 CFR 210 for Manufacturing, Processing, Packing, or Holding of Drugs
21 CFR 211 for Finished Pharmaceuticals
21 CFR 211.165 requires manufacturers of OTC products to conduct laboratory testing prior to release and distribution:
For each batch of drug product, there shall be appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release.
There shall be appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable microorganisms.
Certifications & Accreditations
Certified Laboratories is a fully compliant cGMP/GLP testing facility following 21 CFR 111 sub J and ISO 17025 standards.
Burbank, CA
Formerly Micro Quality Labs
- FDA (21 CFR 210, 211)
- ISO 17025:2017 – Biological
- ISO 17025:2017 – Chemistry
- DEA
- Health Canada
Carrollton, TX
Formerly Microconsult
- FDA (21 CFR 210, 211)
- ISO 17025:2017
- ISO 9001
- DEA
- Health Canada
OTC Product Stability Testing to Meet Regulatory Requirements
21 CFR 211.166 requires manufacturers to assess the stability characteristics of OTC drug products via stability testing. This provides the data needed to establish a scientifically backed expiration date on your product label, per FDA requirements.
Certified Laboratories maintains one of the most sophisticated and capable OTC stability testing laboratories in the industry:
- >100 stability chambers
- Full range of storage conditions based on ICH guidelines
- Long-term, intermediate, accelerated, and photostability protocols
- Active ingredient assays
- Microbial limits
- BP, EP, JP, and USP Monographs Tests
- Antimicrobial effectiveness/PET
- Color
- Odor
- Appearance
- pH
- Specific Gravity
- Viscosity
- Package Compatibility
- Hardness
- Weight Loss/Gain
- Period-After-Opening
- Freeze/Thaw Analysis
- Ambient/Above Ambient
- UV
Simple 4-Step Process to Start Your Lab Testing Program
Customize Your Plan
We identify what testing services you need.
Submit Samples
Ship yourself or use our courier service (subject to geographic requirements).
Laboratory Testing
Our labs perform your cosmetics or personal care product testing.
Receive Results
Use our online portal to access your COA.
Sterility Testing for OTC Drug Products
Additional regulatory requirements include testing to confirm sterility of products purporting to be sterile and/or pyrogen-free, testing for the presence of contaminants in ophthalmic ointments, and dissolution testing for controlled-release dosage forms.
Certified Laboratories can provide the OTC testing services you need to meet FDA regulatory requirements with responsive service and competitive TAT & pricing.
OTC Monograph Testing Services
Compliance with OTC Monographs helps ensure product quality, efficacy, and reliability. We are experts in FDA Monograph testing to meet regulatory requirements.
Our full scope of laboratory capabilities includes chemistry, microbiology, in-package stability and shelf-life, sterility testing, and quantitative components to inform product labeling for both APIs and excipients.
We help you verify product quality with our state-of-the-art equipment and validated/verified methods. Our OTC test services are listed below; contact us if you don’t see what you need.
Chemistry Testing for OTC Drug Products
- >100 stability chambers
- Full range of storage conditions based on ICH guidelines
- Long-term, intermediate, accelerated, and photostability protocols
- Active ingredient assays
- Microbial limits
- BP, EP, JP, and USP Monographs Tests
- Antimicrobial effectiveness/PET
- Color
- Odor
- Appearance
- Appearance
- Moisture
- GMOs
- Mycotoxins
- Heavy metals
- Allergens
- Pesticides & PCBs
- Adulterants
Sterility Testing for OTC Drug Products
- Preservative Efficacy
Microbiology Testing for OTC Drug Products
- Microbial/Pathogen Contamination
- Preservatives
- Challenge Studies
- Probiotics
- Microbial Enumeration
In-Package Stability and Shelf-Life Testing for OTC Drug Products
- Degradation
- Accelerated
- Photostability
Organoleptic Analysis for OTC Drug Products
- Flavorings
- Colors
- Textures
- Odors
Why Choose Our OTC Testing Lab for Your Product Analysis?
Competitive TAT
Turn-key pricing
24/7/365 dedicated, reliable service
Direct access to your experienced lab manager and technical team
Real-time data access – anytime, anywhere
Flexible courier service
Over-the-Counter (OTC) Drug Products We Test
Our OTC testing lab can analyze a broad range of over-the-counter (OTC) drug products, including the following (contact us if you don’t see what you need):
- Acne medication
- Dandruff shampoo
- Cough suppressants
- Decongestants
- Fever reducers
- Pain reducers
- Antihistamines
- Anti-diarrheal products
- Topical analgesics
- Sunscreen
- Eczema cream
- Ophthalmic solutions
Experts in FDA Regulatory Consulting
Our regulatory arm, EAS Consulting Group, specializes in providing comprehensive regulatory consulting services for the OTC drug industry. Our team of experts assists with every aspect of OTC drug product compliance related to FDA regulations and standards. We navigate the complexities of monographs, GMP compliance, and cosmetic-to-OTC crossovers, offering tailored support to meet your specific needs.
- Compliance with GMP, GLP, and GCP, offering facility audits, mock FDA inspections, training, quality system implementation, and 483/warning letter remediation.
- Label and formula review for compliance with OTC drug monographs.
- Facility registration, drug listing, and annual report submissions for FDA-registered facilities.
- Cosmetic-to-OTC crossover expertise, including ensuring appropriate labeling for products that meet OTC drug monograph requirements, navigating cosmetic vs. OTC requirements, and clarifying the legal distinctions between product categories.
- 483/warning letter/consent decree/recall remediation expertise and assistance.