News & events

According to the FDA, ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs. ARL Bio Pharma has GMP software that controls our laboratory’s instruments and generated data. This software complies with 21CFR Part 11 as it relates to electronic records. All data is locked down

How are endotoxin limits calculated? How do my endotoxin test results relate to those limits? Endotoxin limits for drug products specify the amount of endotoxin that can safely be present. Limits are based on human tolerance and generally specified in the USP monograph or if no monograph exists, calculated via USP <85> Bacterial Endotoxin Test.

Hand sanitizers are regulated as over the counter (non-prescription) drugs by the U.S. Food and Drug Administration. The FDA has issued warnings to consumers about hand sanitizer products containing methanol. According to the CDC, Alcohol-based hand sanitizers should only contain ethanol or isopropanol, but some products have been found to contain methanol. Ethanol is a

Dr. Nicole Vu, Scientific Director, ARL Pharmaceutical ingredients are controlled by cGMP regulations. Users of pharmaceutical materials should be informed regarding when the material can be re-tested for continued use. ICH Q1A(R2)/FDA Definition: Expiration date: The date placed on the container/labels of an API designating the time during which the API is expected to remain within

Particulate matter contamination in injectable drug products, especially in large numbers, can cause harm to patients. Common particulate sources include: solvent impurities, drug precipitates, dust, glass, rubber, environmental contaminants, fibers and other insoluble materials.  The size of particulate matter is an important factor when considering the potential risk to patients. Particles as small as 2 μm in

Today, FDA issued updated guidances to provide additional clarification on testing of alcohol used in hand sanitizers manufactured under FDA’s temporary policies to help ensure that harmful levels of methanol are not present in these products. This will help ensure widespread access to alcohol-based hand sanitizers that are free of contamination. FDA has updated their guidances to provide clarification