ARL Bio Pharma provides GMP testing for 503B outsourcing facilities. Our validated methods meet GMP requirements for analytical and microbiological testing.
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.
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
- 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.
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
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.
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.
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.
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
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 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.
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.