Services

Quality Assurance

American Antibiotics Quality Assurance Department is involved in all aspects of projects, from introduction through technical document preparation, to commercial launch and GMP manufacturing.

QA is involved in the following areas:

Audits

American Antibiotics has been inspected by the U.S. Food and Drug Administration. In addition, American Antibiotics Quality Assurance department routinely hosts client audits for compliance, GMP, environmental safety and security.

Sampling and Release of Materials

All materials received by American Antibiotics undergo QA inspection, quarantine, sampling and release. Materials entering American Antibiotics are sampled in a dedicated sampling location according to a statistical sampling plan. These materials are held in quarantine until tested by QC and formally released by QA.

Finished Product Release

The Quality Assurance Department provides oversight of the manufacturing and packaging processes through its Operations group - from manufacturing to batch record review and ultimately the final release of the product.

Documentation

Quality Assurance is an integral part of American Antibiotics’s documentation process. Master Production Records, Master Packaging and Labeling Records, Stability Protocols and all regulatory documents are drafted, reviewed and approved either by or with QA input. Completed documents are tracked, reviewed and retained by the QA Document Control function.

Samples

In addition to client and process-stipulated samples, Quality Assurance withdraws documentary retention samples of every batch of product American Antibiotics manufactures. Raw Materials, In-Process phases, Finished Dosage forms and representative packaging samples are all withdrawn according to American Antibiotics SOPs and retained for future reference. All samples are stored in controlled environment locations for a minimum of 21CFR specified durations.

Cleaning of Equipment

QA is responsible for the release of all equipment and rooms to manufacturing. American Antibiotics develops and validates analytical cleaning methods for all compounds manufactured at our facility. Equipment cleaning procedures are developed for the compound from analytical methods. Cleaning verification is performed on all equipment after manufacturing while cleaning validation is performed only on commercial product.

Vendor Qualification Program

Vendor qualification is coordinated by the QA department and Includes interaction with contract laboratories. Vendors are qualified for their materials and supplies by survey, audit, analytical analysis and evaluation.

Quality Engineering

The Quality Engineering function has responsibility for key metrics and analysis for the company. The trending of client audit responses and critical production parameters form an instrumental part of a customized training program. Tracking investigations, conducting annual reviews, trending attributes and reporting these to the individual departments and the company’s top management are just some of QE’s routine activities.

 

Capabilities

American Antibiotics beta-lactam antibiotic manufacturing capabilities Include the following:

  • Tablets (uncoated, film-coated, enteric-coated and sugar-coated)
  • Capsules
  • Modified release tablets and capsules (extended release, delayed release and long acting)
  • Powders
  • Granules
  • Oral Suspensions
  • Injectables