OR WAIT null SECS
June 02, 2019
Quality and compliance depend on the right approaches to training, standard operating procedures, and validation. More tools are available to help ensure success.
Protecting the integrity of raw data is crucial to regulatory compliance and to proving that manufacturing and quality operations are being run and managed properly.
May 30, 2019
The company is voluntarily recalling Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), to the consumer level because microbial growth was detected.
May 22, 2019
Violations found by FDA included a failure to test product for API identity and strength, failure to validate outsourced materials, and a lack of written cleaning procedures.
Inspectors found a lack of control over computer systems and a failure to follow equipment cleaning and maintenance procedures.
May 17, 2019
TraceLink will participate in the agency’s Pilot Project Program under the Drug Supply Chain Security Act.
May 15, 2019
The company is recalling the lots because of possible peanut flour contamination.
The agency is warning these manufacturers that they are putting consumers at risk with substandard manufacturing practices.
Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.
Quality cannot be verified through testing, especially at the limit of detection, and no test method can confirm the absence of a microbe or particle.