ARL Bio Pharma provides GMP testing for 503B outsourcing facilities. Our validated methods meet GMP requirements for analytical and microbiological testing.
Submit Samples for testing through ARL's Client Portal.
ARL Bio Pharma has extensive experience in analytical method development/validation for a variety of drug substances and products.
Our laboratory validates analytical methods based on ICH, USP, FDA and industry best-practice guidelines. Validation parameters are based on USP <1225> Validation of Compendial Procedures, including: Accuracy, Linearity, Precision, Range, Specificity, and System Suitability. Additional validation characteristics are available. Forced degradation/ stress studies are utilized for the development and validation of stability-indicating methods for incorporation into a stability study program.
This test measures the concentration of the active ingredient at a specific point in time. GMP potency testing uses laboratory methods developed and validated for client specific formulations.
Articles:
- Benefits of Submitting Master Formulation Records
- Chemical Testing Aspects of USP 797 for Compounded Sterile Preparations
- Drug Formulation and Its Impact on Analytical Testing
- Importance of Sample Amounts and the Impact on Potency Testing
- Potency Test Failure Case Studies
- Potency Test Results
- Potency Testing Benefits and Requirements
- Stability vs. Potency Testing
- T3/T4 Formulations
- Test Specifications
A stability study measures the extent to which a product retains, within specified limits, and throughout its period of storage and use, the same properties, and characteristics that it possessed at the time of compounding.
Stability Studies for sterile products commonly include:
- A stability-indicating potency assay method
- Sterility
- Endotoxin
- pH
- Visual inspection
- Particulate matter
- Preservative effectiveness
- Preservative quantification
- Container Closure Testing
Non-sterile product stability studies replace sterility and endotoxin testing with Bioburden/ microbial limits testing and dosage form dependent tests for the Absence of specified organisms.
Articles:
- Chemical Stability of Admixtures Containing Ziconotide 25 mcg-mL and Morphine Sulfate 10 mg-mL or 20 mg-mL During Simulated Intrathecal Administration
- Compatibility and Stability of Palonosetron Hydrochloride and Propofol During Simulated Y-Site Administration
- Compatibility and Stability of Palonosetron Hydrochloride with Four Neuromuscular Blocking Agents During Simulated Y-Site Administration
- Compatibility and Stability of Palonosetron Hydrochloride with Gentamicin Metronidazole or Vancomycin During Simulated Y-Site Administration
- Compatibility of Caspofungin Acetate Injection with Other Drugs During Simulated Y-Site Coadministration
- Compatibility of Micafungin Injection with Other Drugs During Simulated YSite Coadministration
- Drug Compatibility with a New Generation of VISIV Polyolefin Infustion Solution Containers
- Extending Beyond Use Date for Compounded Preparations
- Importance of Forced Degradation in Stability Indicating Methods
- Palonosetron Hydrochloride Compatibility and Stability with Three Beta-Lactam Antibiotics During Simulated Y-Site Administration
- Pharmaceutical Compounding Errors
- Physical and Chemical Stability of Palonosetron Hydrochloride with Glycopyrrolate and Neostigmine During Simulated Y-Site Administration
- Physical and Chemical Stability of Palonosetron with Metoclopramide and Promethazine During Simulated Y-Site Administration
- Proactive Approaches to Mitigate Stability Failures
- Quality Control Analytical Methods-Stability Versus Potency Testing-The Madness is in the Method
- Stability of Metronidazole Benzoate in SyrSpend SF One-Step Suspension System
- Stability vs. Potency Testing
- What Factors Influence Stability?
Webinars:
- Beyond Use Date Strategies for Compounded Preparations
- Compounded Sterile Products: Extending Beyond Use Dating and Batch Release Testing for 503A and 503B Facilities
- Extending Beyond Use Dating for Compounded Preparations
- Root Causes of Stability Failures
- Stability Indicating Methods
- Stability Studies: Architecture Behind Establishing a Beyond Use Date
- Stability Testing: Science and Compliance
The container closure system for a drug product provides critical protection for stability and sterility. ARL offers USP <1207> container closure integrity testing (CCIT) on IV bags, syringes, cassettes, and vials. Three types of leaks that can be detected during CCIT include:
- Entry of microorganisms
- Escape of the product dosage form or entry of liquids or solids
- Escape of nitrogen gas or entry of oxygen, water vapor, or air gase
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A sterility test detects microbial contamination. A satisfactory result indicates that no contaminating microorganism has been found in the sample examined under the conditions of the test. Method suitability is performed to ensure contamination can be detected under the conditions of the test, providing confidence in the test result.
Articles:
- Applications and Sterility of Autologous Serum Eye Drops
- Basics of Sterility Testing
- Laboratory Considerations of USP Chapter 71 Sterile Tests
- Method Suitability and Its Importance to the Test Method
- Open vs Closed Membrane Filtration Systems
- Sterility Test Failure: Possible Causes and Investigation
- The Importance of Sterility Test Volume and Method Suitability Testing
- USP 71 Sterility Testing
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A rapid sterility test detects microbial contamination. This validated alternative sterility test method per USP <1223> is effective and reliable for 503A and 503B Facilities. Rapid test provides objective results in as little as six days. Method suitability is performed to ensure contamination can be detected under the conditions of the test, providing confidence in the test result.
Articles:
- Dispense Drugs Faster with Rapid Sterility
- Rapid Sterility Testing
- Rapid Sterility Testing for Compounding Pharmacies
Webinars:
An endotoxin test detects toxins that are released from the cell wall of disrupted gram-negative bacteria. Method validation is available to ensure the ideal test method is used consistently, and the most accurate results are reported.
Articles:
- Comparison of Endotoxin Testing Methods for Pharmaceutical Products
- Endotoxins
- Endotoxin Challenge Vials
- Endotoxin Essentials
- Endotoxin Limits
- The Importance of Endotoxin Testing
- USP <85> Bacterial Endotoxin Validation and Its Importance to the Test Method
Webinars:
USP, EP, BP, and JP compendial testing qualifies drug substances and excipients as well as drug products to meet pharmacopeia specifications. Compendial testing of raw materials is a critical component of a supplier/ vendor qualification program. Testing consists of procedures and acceptance criteria that help ensure the identity, strength, quality, and purity of the article.
A particulate matter tests for the presence of extraneous substances including: dust, glass, drug precipitates, rubber and other insoluble materials.
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Growth Promotion demonstrates that media used in environmental monitoring programs, media fills, or personnel qualification are capable of supporting microorganism growth.
Growth Promotion Sample Submission form
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This test identifies microorganisms isolated during different phases of manufacturing and quality testing to the genus/species level using DNA sequencing. Microbial Identification is also critical in a Sterility Out-of-Specification investigation, and useful information during Bioburden testing.
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Microbial cleaning studies are essential to validating a facility’s cleaning SOP. Pharmacies must demonstrate that cleaning agents, combined with instructions and procedures for their use, remove microbial contamination from surface areas where sterile drug products are compounded.
Articles:
An antimicrobial effectiveness test demonstrates the effectiveness of antimicrobial preservatives in preventing microbial proliferation in injections, topicals, oral products, and multiple-dose containers.
Articles:
- The Essentials of USP <51>
- Essentials of United States Pharmacopeia Chapter 51 Antimicrobial Effectiveness Testing
- Minor Chapters, Major Impacts – What USP Chapters 51, 61, 62, and 1207 Mean for Your Compounding Practice
- USP <51> Antimicrobial Effectiveness Testing
Webinars:
These tests quantitate the total population of aerobic bacteria, yeast, and molds in raw materials, in-process samples, and finished products. This is commonly referred to as bioburden testing.
Articles:
- Microbial Tests for Non-Sterile Products
- Microbial Limit Tests for Nonsterile Pharmaceuticals Part 1
- Microbial Limit Tests for Nonsterile Pharmaceuticals-Part 2
- Minor Chapters, Major Impacts – What USP Chapters 51, 61, 62, and 1207 Mean for Your Compounding Practice
- USP <61> and USP <62> Microbial Tests for Non-Sterile Products
Webinars
These tests verify the absence of objectionable microorganisms in drug products and raw materials.
Articles:
- Microbial Tests for Non-Sterile Products
- Microbial Limit Tests for Nonsterile Pharmaceuticals Part 1
- Microbial Limit Tests for Nonsterile Pharmaceuticals-Part 2
- Minor Chapters, Major Impacts – What USP Chapters 51, 61, 62, and 1207 Mean for Your Compounding Practice
- USP <61> and USP <62> Microbial Tests for Non-Sterile Products
Webinars
Microbiological Examination of Nonsterile Products – Tests for Burkholderia cepacia Complex USP <60>
This test procedure evaluates the microbiological quality, specifically the presence of species of the genus Burkholderia, in non-sterile substances and preparations. This is important, because Burkholderia is a potentially dangerous pathogen, especially for drugs or raw materials that are intended for inhalation use, and aqueous preparations for oral, oromucosal, cutaneous, or nasal administration.
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This test measures the degree of uniformity in the amount of the drug substance among dosage units. It is based on assay of individual content of drug substance(s) in a number of dosage units to determine whether the individual content is within the specified limits.
This test measures the level of hazardous drug surface residue to verify workplace safety.
Available drugs: Estriol, Estradiol, Estrone, Testosterone, Progesterone, Testosterone Propionate, Testosterone enanthate, Testosterone Cypionate, and Methotrexate
Articles:
- USP <800> Surface Wipe Sampling
- USP <800> Why should you test?
- USP <800> Environmental Monitoring Requirements Q&A
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