Quality Systems

Articles

The US Pharmacopeial Convention released new and revised standards for compounding nonsterile medicines, sterile medicines, and radiopharmaceutical drugs. 

USP Publishes Compounding Standards

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

CDER’s KASA program seeks manufacturer data on drug attributes and risks to inform oversight.

FDA Advances New Approach to Drug Quality Assessment

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

A good working relationship between sponsor and contractor will become invaluable when an OOS occurs, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Quality Agreements and Out-of-Specification Investigations

Agnes Shanley is senior editor of Pharmaceutical Technology.

Quality and compliance depend on the right approaches to training, standard operating procedures, and validation. More tools are available to help ensure success.

Good Laboratory Practices: Getting on the Same Page

Orlando LÃ³pez is a senior consultant at McNeil Consumer Healthcare, a J&J company.

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.

Defining and Managing Raw Manufacturing Data

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. 

Heritage Pharmaceuticals Inc. Recalls Products Due to Sterility Failure

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. 

FDA Warns Canadian OTC Manufacturer

Inspectors found a lack of control over computer systems and a failure to follow equipment cleaning and maintenance procedures.

Data Integrity Violations Found at India Facility

TraceLink will participate in the agency’s Pilot Project Program under the Drug Supply Chain Security Act. 

FDA Accepts TraceLink DSCSA Pilot Submission

The company is recalling the lots because of possible peanut flour contamination.

Quality Assurance/Quality Control