Quality Systems

Quality Systems

Oakwood Labs maintains rigorous in-house quality systems, including Quality Assurance and Validation, QC Microbiology, and QC Chemistry. Oakwood is highly committed to quality, and has a long history of compliance.

Quality Assurance/Validation

Oakwood has a documented Quality Management System (QMS) designed and implemented to fulfill the following regulatory requirements:

  • FDA 21 CFR Part 210 and 211 cGMP in Manufacturing, Processing, Packing, or Holding of Drugs and Finished Pharmaceuticals
  • FDA 21 CFR Part 4, Regulation of Combination Products
  • FDA 21 CFR Part 11 Electronic Records and Electronic Signatures
  • ICH Q10 Pharmaceutical Quality System

The Quality System ensures that product manufactured at Oakwood complies with specified requirements and is safe, pure, and effective throughout the product lifecycle. There are three major purposes of Oakwood’s quality system:

  • Achieve Product Realization: to maintain a system that provides delivery of products that meet defined quality attributes to meet the needs of patients and customers.
  • Establish and Maintain a State of Control: Use of effective monitoring of process performance and product quality to provide assurance of capability of the manufacturing and testing processes.
  • Facilitate Continual Improvement: Identification and implementation of process and process improvements, enhancements to the quality system, and reduction of variability.

Oakwood’s Quality System includes the following areas:

  • Documentation control
  • Change management
  • Material and component control and evaluation
  • Investigations and deviations
  • Corrective and preventative action
  • Internal audits
  • Supplier qualification
  • Production oversight
  • Facility, utility, and equipment validation
  • Process validation: sanitization, cleaning, manufacturing, and continued process verification

QC Microbiology/QC Chemistry

Oakwood’s Quality Control departments include fully functional and approved Chemistry and Microbiology labs. The Oakwood Quality Control departments can handle technically complex projects and perform testing to support clinical trial or commercial products. Oakwood’s Quality Control departments offer the following in-house services:

  • Development and validation of test methods
  • Incoming testing of components and raw materials
  • Routine monitoring of facility and utilities
  • In-process, finished product, and stability testing