Case Studies for Pharmaceutical Packaging Solutions
Due to dynamic market needs, a pharmaceutical manufacturer required products to be redressed in a very short amount of time. Adding to the challenge was the fact that the drug was of a sensitive nature, requiring a full-level of segregation from any other pharma product.
QPSI identified a segregated Class A site in close proximity to our resources to cost-effectively support the full scope of project requirements and gained customer approval for the site. QPSI established a fully operational site within 14 days, including a short-term lease, site insurance, cGMP systems installation, procedures to meet industry standards and requirements, implementation of an extensive IT plan for internal and external customer connectivity, installation of the necessary equipment to support operations, and execution of master batch record protocol. In addition, a full Quality System was established to support double-digit batch record review on a daily basis. The customer resides on-site daily, collaborating with us to ensure timely production throughout.
All departments both internally and externally worked to support the objective and the site started up on-time and is achieving productivity rates at or above planned throughputs. Maximum segregation is achieved with ALL personnel unique to the site, including shared services. The customer has increased the project scope and volume due to the success of the operation.