“At Pharmaceutic Labs,
our quality assurance seal means
excellence in quality and safety.
The people, process, and facility are held
to the highest possible standards.”
~ Ernesto Samuel, CEO

Quality Assurance Program

Quality Assurance

Training, procedures, equipment, and stringent compliance with state and federal regulations have established Pharmaceutic Labs as a top tier company for quality assurance. Our people, processes and facility meet or exceed industry standards set by the Drug Quality and Security Act. The quality and safety of our products is of the upmost importance and the basis upon which all decisions are made.

Our People

Pharmaceutic Labs delivers the highest quality and safest drugs to customers because our team makes it possible. Our executives have extensive CGMP experience in sterile manufacturing, working with the FDA for over 30 years. Each employee is hired and trained to meet the latest guidelines for drug quality and safety. Everyone at Pharmaceutic Labs plays a vital role in the process of manufacturing products to meet our standards for quality. Working together, each step of the process is governed by an employee who specializes in that task. Our commitment to quality could not be possible without employees who are dedicated to patient safety. The Pharmaceutic Labs training program thoroughly prepares employees for their tasks. It includes CGMP, sterile aseptic practices, and training on each SOP (Standard Operating Procedure). Upon completing the training, employees are assessed to ensure proficiency in each subject area as well as a thorough knowledge of the Quality and Safety Act. Pharmaceutic Labs employees are trained routinely to guarantee the quality of our products and to encourage the continuous professional development of staff.

Our Process

Pharmaceutic Labs’ manufacturing process adheres to 21 CFR Part 210 by defining quality matrixes and implementing them, including: a CGMP for raw materials management, production management, daily environment monitoring, full sterility, pyrogen testing and full quality control release testing. We believe in transparency, providing customers with direct access to audit reports. There are no shortcuts in producing quality drug products. Pharmaceutic Labs implements a quality assurance program with procedures and documentation. Dedicated Quality and Regulatory corporate oversight guarantees product safety as well as third party accreditations, such as JCAHO (Joint Commission on Accreditation of Healthcare Organizations). Our Corrective Action and Preventive Action (CAPA) plans are managed according to the FDA guidelines. As part of the Quality Management SOPs for 21 CFR Part 210, we ensure all products undergo full validation protocols, including: operations/production SOPs (standard operating procedure), training SOPs, Quality Control release tests SOPs, equipment validation and qualification SOPs, product complaint SOPs, and FDA inspections SOPs. All equipment is validated and qualified annually. Our manufacturing process guarantees that all products have successfully passed all quality control release testing. Will review and approve all quality control tests before products are shipped.

Our Facility

The quality of our products is contingent upon the Pharmaceutic Labs 503B outsourcing facility. Designed specifically for the sterile manufacturing of admixing products and includes segregated areas for non-sterile compounding and cosmetic lab, it adheres to 21 CFR Part 211. Sterile products are made in ISO 5 equipment to ensure complete patient safety. Our cleanrooms have ISO 7 classification, governing the anteroom and gowning room with daily dynamic environmental monitoring. The facility has ISO 5 equipment for dispensing along with dedicated ISO 5 isolators, pass through windows, a dedicated HVAC system, and seamless cleanroom floors. Our staff is required to wear sterile garments or personal protection equipment. Every detail of our outsourcing facility signifies our commitment to uphold CGMP.