Axia Pharmaceutical Complies with All cGMP Requirements Mandated for Outsourcing Facilities

Current good manufacturing practices, or cGMPs, are a series of regulations established and enforced by the FDA to ensure the quality and safety of pharmaceuticals. They ensure the identity, quality, strength, and purity of pharmaceutical products by requiring manufacturers to control their manufacturing facilities and processes adequately. It involves the following aspects:

• Environmental monitoring process control procedures are required of all facilities used in manufacturing to control production, thereby preventing product defects.
• Personnel monitoring ensures the sanitation and hygiene of workers involved in manufacturing through routine examinations.
• SOPs and batch records are documentation programs that govern the operations of a facility and ensure accurate and complete recordkeeping.
• Quality control processes ensure the qualification and validation of all equipment and records to reliably show that all products meet the specific purity, quality, strength, and identity requirements.
• Quality assurance involves ongoing training, education, and audits to reinforce the knowledge and commitment of all operators and staff involved in drug production.

At Axia Pharmaceutical, we comply with and exceed all cGMP requirements mandated for outsourcing facilities. Please see Our Facility for more information about our laboratory.