September 18, 2018
Pharmaceutical drug manufacturing involves much more than producing product in the desired quantities. At WDPrx, quality and care are two virtual ingredients added to every formulation.
We specialize in non-sterile oral solutions, liquid solutions, suspensions and semi-solids. Our knowledge helps clients contain costs which helps maintain a competitive advantage. Flexibility is built into our facility enabling batch sizes in small or large quantities. Procedures follow cGMP guidelines for development, testing, manufacturing and packaging. Manufacturing suites include segregation and engineering controls.
The WDPrx team applies extensive expertise in pharmaceutical manufacturing to assure timely production according to client specifications resulting in high quality product distributed on schedule to meet the needs of patients.
Need more or less? WDPrx is able to modify production batch sizes according to client instruction and market demand. Establishing batch size is an important element in pharmaceutical manufacturing. Guidance about optimal batch size is provided by the FDA’s cGMP guidance. Several factors affect minimum batch size including API percentage in the formulation and the selected manufacturing process. WDPrx assists with the documentation and filing requirements to modify batch sizes that enables production to continue on schedule.
WDPrx applies cGMP guidelines to assure drug products are manufactured that meet all attributes they are intended to possess. Effective process validation involves analysis of data collected through testing phases leading to high product consistency and quality during manufacturing.
Cleaning validation procedures are designed to assure that residues are removed from equipment and that cleaning supplies are suitable and appropriate for their purpose. Proper cleaning validation minimizes the potential for cross-contamination. Before designing cleaning procedures, WDPrx determines all physical and chemical characteristics of the product ingredients.
The Quality Assurance team at WDPrx is trained to monitor all aspects of the development, manufacturing and distribution processes that affect drug product quality. The QA team often recognizes quality issues and corrects them before they affect the final product.
Sampling, specifications and testing are the authority of the WDPrx Quality Control (QC) department. Raw materials are not authorized for use until all necessary tests are conducted and results analyzed according to cGMP guidelines. When the QC department is assured of appropriate product quality, materials are released for manufacture and distribution.
Drug safety is a primary focus of the WDPrx Microbiology Lab. Microbial contaminants affect the purity of pharmaceutical drug products. The Microbiology Lab at WDPrx conducts a variety of tests designed to detect micro-organisms in water and other drug manufacturing components. Effective microbiological testing ensures the finished product is sterile.