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The Pharmaceutical 3PL Guide to Quality Assurance

At reputable pharmaceutical 3PL companies, the Quality Assurance Team works behind the scenes to implement a Quality System – procedures that establish control over logistics operations, packaging and labeling and other functions to promote continuous improvement just like the famous scene from the movie The Wizard of Oz when the Great and Mighty Wizard is revealed behind the curtain.

Internal procedures are based on current Good Manufacturing Practices and current Good Distribution Practices, also called cGMP and cGDP administered by the U.S. Food and Drug Administration (FDA). Instructions about cGMP and cGDP procedures are documented in the Quality Manual maintained by the pharmaceutical 3PL Quality department.

Quality Team

Because the Quality Assurance team evaluates business operations, it operates within reputable 3PL companies as an independent authority reporting directly to the company President.  The QA department reviews and approves procedures and must take action upon any deviation from established practices.  When issues arise, the Quality Team assesses data, investigates the issue’s origins, conducts an investigation and determines a resolution to further a culture of continuous improvement.

Results

The work of a professional Quality Assurance team promotes the safety and effectiveness of medications for patients.  The consistent application of cGMP and cGDP guidelines assures predictability and reliability when following instructions, establishes a culture built around safety and instills confidence in the work of the 3PL from clients and regulatory authorities.

Logistics

At WDSrx and other reputable 3PL companies, Quality plays an important role in logistics operations.  The proper implementation of cGDP guidelines helps reduce risk and minimize damage to inventory. It is the Quality department that helps assure product integrity by supervising proper disposition of damaged product, recognizing product mis-labeling and investigating product that is unaccounted for due to counterfeiting or diversion.  Every stage of inventory flow including product receipt, quarantine, release, storage and distribution is monitored by the Quality Assurance Team.  Standard Operating Procedures are written instructions developed by the Quality department detailing specific tasks enabling multiple employees to perform the same job responsibilities in a consistent manner.  Efficient operations in a pharmaceutical logistics company rely on each employee focusing on their individual contribution to the overall success of the process to streamline the delivery of treatments to patients.

Packaging and Labeling

Packaging and labeling of oral solid dose and liquid medications is managed on-site at WDSrx for manufacturers in addition to logistics services.  This complementary capability benefits companies that also choose to partner with WDSrx for product storage and order fulfillment.  Quality Assurance is actively involved with the Packaging and Labeling department by developing SOP documents maintaining compliance of personnel, equipment, procedures, environment and product safety.  For example, proper documentation must be provided for components, drug product containers, labels, ingredients sampling and testing prior to approving work projects.  Product integrity and patient safety are the focus of reputable Quality Assurance departments.

CAPA

The Quality Team identifies deviations from standard procedure.  They are also responsible to investigate the root cause of the issue and implement changes to prevent reoccurence.  This process is called CAPA, short for Corrective Action/Preventive Action.  By evaluating the cause of problems, analyzing data and implementing changes, operations are maintained with a focus on continuous improvement for enhanced efficiency.

CONCLUSION

The Wizard in the Wizard of Oz guided Dorothy and her friends throughout their journey until they achieved their goal.  The Quality Assurance department oversees operations at WDSrx and other pharmaceutical 3PL providers to help assure procedures meet strict standards for patient safety that contribute to greater efficiency and client satisfaction.

For further information about Quality Assurance and WDSrx watch the Quality Assurance video series or contact Larry Hotz, (561) 998-3885 x304 or lhotz@wdsrx.com

Are any Controlled Substances (CII) included in your return? If so, please press "Yes" and complete the DEA 222 Request Form. You can also contact Jason Solomon at jsolomon@wdsrx.com or (561) 998-3885 x316.