Analytical Quality and Compliance

PPD is an industry leader in providing quality cGMP analytical testing services to the pharmaceutical and related industries. We consistently meet or exceed our clients' expectations. In order to do so, we comply with all regulatory requirements, company operating procedures and testing methods. We also commit to continuous improvement and implementation of better processes and organizational efficiencies as well as educate, train and support our employees so they can offer quality services.

Quality Makes a Difference

Rigorous training and well-defined processes ensure consistent and timely analytical data:

• New employees receive extensive training in cGMP, standard operating procedures (SOPs), high performance liquid chromatography (HPLC), and lab techniques and methods
• An independent quality assurance department reviews 100 percent of all data and reports
• A broad range of specialized informational technologies and expertise are used to manage quality systems and monitor program performances
• Regular meetings are conducted to assess the effectiveness of corrective and preventative actions (CAPA) and, when necessary, evaluate further actions for implementation
• Routine internal and external audits for cGMP compliance, including external certification of European Union (EU) directive compliance, assure that our quality systems are consistent with current industry standards

A dedicated team supports cGMP functions, such as:

• Installation, operational and performance qualification (IQ/OQ/PQ) of analytical instrumentation
• Calibration, validation and preventative maintenance of equipment and stability chambers
• Sample management
• Computer validation, database management and software development
• Report writing