case study

Improved Product Release Cycle Times, Improved Bottom Line

A generic pharmaceutical manufacturer was interested in applying lean principles to the operation of the Quality team, with the objective to reduce the product release timeframe. However, they lacked internal experience to embark upon this initiative.

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Improved Product Release Cycle Times, Improved Bottom Line

Background

A generic pharmaceutical manufacturer was interested in applying lean principles to the operation of the Quality team, with the objective to reduce the product release timeframe. However, they lacked internal experience to embark upon this initiative.

Undertaking this product release cycle time project across multiple plants freed up $50 million cash flow, giving the quality organization kudos throughout the company.

Solution

The pharmaceutical company looked to the Regulatory Compliance Associates® Inc. experts to improve efficiencies in the manufacturing, batch approval and release of the product to the distribution system.

The RCA experts used process mapping to identify redundancies, inefficiencies, and other areas of opportunity. In partnership with the company process owners, new processes were systematically developed and implemented in Quality as well as Manufacturing operations.

Result

The RCA experts reduced the 30 day product release process down to four days. This cycle time improvement reduced the time necessary for the company to retain costly unreleased inventory, allowing them to reduce the inventory investment by improving speed and reliability of product delivery to customers. This reduction in product release cycle time across multiple plants impacted the company’s cash flow, which internal experts estimated to be $50 million.*

By moving work-in-progress product more quickly into finished goods inventory, the company lowered carrying costs and floor space cost. By reducing the product release cycle time, the plant experienced less issues with back orders and short-dating. Additionally, for some export markets, the plant was able to ship product less expensively via boat instead of air.

*Cash Flow Improvement = product unit cost X # units produced/day X # days release cycle time improvement

Background

A generic pharmaceutical manufacturer was interested in applying lean principles to the operation of the Quality team, with the objective to reduce the product release timeframe. However, they lacked internal experience to embark upon this initiative.

Undertaking this product release cycle time project across multiple plants freed up $50 million cash flow, giving the quality organization kudos throughout the company.

Solution

The pharmaceutical company looked to the Regulatory Compliance Associates® Inc. experts to improve efficiencies in the manufacturing, batch approval and release of the product to the distribution system.

The RCA experts used process mapping to identify redundancies, inefficiencies, and other areas of opportunity. In partnership with the company process owners, new processes were systematically developed and implemented in Quality as well as Manufacturing operations.

Result

The RCA experts reduced the 30 day product release process down to four days. This cycle time improvement reduced the time necessary for the company to retain costly unreleased inventory, allowing them to reduce the inventory investment by improving speed and reliability of product delivery to customers. This reduction in product release cycle time across multiple plants impacted the company’s cash flow, which internal experts estimated to be $50 million.*

By moving work-in-progress product more quickly into finished goods inventory, the company lowered carrying costs and floor space cost. By reducing the product release cycle time, the plant experienced less issues with back orders and short-dating. Additionally, for some export markets, the plant was able to ship product less expensively via boat instead of air.

*Cash Flow Improvement = product unit cost X # units produced/day X # days release cycle time improvement

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