503B Outsourcing Facility

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. 

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Method Development and Validation

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.

Potency Testing

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.

Stability Studies

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.

Container Closure

The container closure system for a drug product provides critical protection for formulation stability and sterility. ARL offers USP <1207> compliant container closure integrity testing (CCIT) on IV bags, syringes, vials, and other packaging systems.

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 gases

Sterility USP <71>

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.

Rapid Sterility

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.

Endotoxin USP <85>

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.

Compendia Testing or Component Testing (Bulk Drug Testing)

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.

Particulate Matter USP <788>/<789>

This test quantifies subvisible particles and evaluates drug products for the presence of extraneous substances including dust, glass, drug precipitates, rubber, and other insoluble materials.

  • USP <788> is for injections and parenteral infusions
  • USP <789> is for ophthalmic solutions

Growth Promotion

This test demonstrates that media used in environmental monitoring programs, media fills, or personnel qualification are capable of supporting microorganism growth.

Environmental and Personnel Monitoring

This test includes incubation/observation of media and microbial identification for Environmental Monitoring plates.

Microbial Identification

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.

Microbial Disinfectant Cleaning Challenge Studies

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.

Antimicrobial Effectiveness Testing USP <51>

An antimicrobial effectiveness test demonstrates the effectiveness of antimicrobial preservatives in preventing microbial proliferation in injections, topicals, oral products, and multiple-dose containers.

Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests USP <61>

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.

Microbiological Examination of Nonsterile Products: Tests for Specified Organisms USP <62>

These tests verify the absence of objectionable microorganisms in drug products and raw materials.

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. 

Content Assay

Qualitative or quantitative measurement of the presence, amount, or functional activity of a target entity (the analyte).

Impurity Assay

This test measures the presence of impurities and provides quantitative measurements.

Reconstitution time

A critical performance parameter, especially for lyophilized products.  The test provides an assessment of dissolution time for preparation of the final solution for patient administration.

Content Uniformity (Uniformity of Dosage Units)

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.

Preservative content testing

This test demonstrates that the declared antimicrobial agent is present at the labeled concentration.

Container Content/ Fill Volume/ Weight Volume (Minimum Fill)

This test ensures that the amount of material filled into the product conforms to the labeled amount.

Dissolution

Quality tests to ensure proper performance of the formulation, generally solid oral dose forms such as tablets and capsules.

USP <800> Surface Wipe Sampling Test

This test measures the level of hazardous drug surface residue to verify workplace safety.

All services provided will adhere to ARL Bio Pharma’s terms and conditions