Skyepharma adopts lean production methods for Right First Time customer satisfaction

Saint-Quentin-Fallavier, France: – In line with its transformation to a full contract development and manufacturing organization (CDMO), oral dosage specialist Skyepharma Productions S.A.S. (Skyepharma) has focused on Right First Time (RFT) by adopting lean production and ‘ground up’ managements approaches.

The initiative is part of a global lean management project started in 2016 at the Skyepharma site in the Auvergne-Rhône-Alpes region, in southeastern France.

Ground up management

Ground up management involves leveraging the experience and skills of production and quality technicians and actively preparing each member of the team for the operations they will have to perform on each product.

By sharing this experience, and anticipating key operations to be performed on the ground, the RFT team has been able to improve operational excellence and reduce the number of errors in batch records.

5S methodology

In part, this has involved implementing the 5S methodology first developed by car manufacturer Toyota in Japan in the 1970s for organization of the workplace.

The method is constructed around five Japanese watchwords:

• Seiri: ‘get rid of’
• Seiton: ‘organize’
• Seiso: ‘clean up’
• Seiketsu: ‘to order’
• Shitsuke: ‘be rigorous’

The 5S tool is now widely used at Skyepharma, says Benjamin Donneau Renard, continuous improvement coordinator and member of the RFT team.

“All services, from logistics to production and laboratory, are positively impacted by us using the 5S approach to optimize how we work,” explains Mr. Donneau Renard.

“It is a tool with many advantages for us in improving safety, raising staff motivation and developing a spirit of rigor and respect for others, improving equipment and process performance, and allowing us to embrace continuous improvement and adopt new practices,” he added.

Examples of 5S implementation are visible across the Saint-Quentin-Fallavier site in clean and clutter-free work areas, storage rooms, archives, etc.

RFT training materials

A further example of RFT management is in the creation and writing of training booklets, as another RFT team member, quality technician Sylvie Comby, explains.

“In order to improve accuracy when filling in records, we introduced new training booklets to support field staff and meet our RFT requirement,” said Ms. Comby.

The benefits are being felt by operators and technicians at Skyepharma.

Manufacturing operator Anthony Franc commented: “Having worked at Skyepharma for less than a year, this support has helped me to work safely and confidently on products I was not familiar with. This sharing of knowledge has allowed for high-quality work.”

New Product Introduction (NPI) department technician Vincent Girardet said: “I have been working at Skyepharma since 2006 in production and for two years in the NPI department. Working between different departments and equipment with product-specific batch records is always complex. This support helped me to quickly and easily adapt and fill out my batch file. The most obvious indicator was that there was no mistakes after proofreading.”

Seamless operations

Skyepharma managers have also noticed benefits.

Head of Pharmaceutical Development Department Aline Moulin comments: “This approach is very important for new products developed at Skyepharma by the development teams, and transferred to production teams. It ensures a seamless operation, resulting in accelerated time to market.”

Production Director Frédéric Checot adds: “RFT is a priority for Skyepharma. It’s a key performance indicator that we monitor every month and that ensures the quality of the products provided to the customer. We have a target of more than 95% of good batches the first time. This objective demonstrates our commitment to reliability for our customers. It guarantees the security of their supply chain and quality first time.”

About Skyepharma Production

Skyepharma Production S.A.S. (Skyepharma) is a specialist CDMO with particular expertise and capabilities in oral solid dosage forms, being a key player in drug development and delivery of oral technologies serving the global pharmaceutical, biotech and consumer health industries.

Skyepharma is the oral business unit of the Vectura Group of companies, an international leader in inhalation and other drug delivery forms.

Located in Saint-Quentin-Fallavier, in the greater Lyon area, the Skyepharma site provides solutions bringing value to its clients at any stage of a product development lifecycle, from early stage development up to commercial manufacturing and packaging activities. Skyepharma’s value proposition includes tailored services to clients’ requirements, supporting them up to market introduction for their solid dosage form projects.

The Skyepharma CDMO offer in solid oral dosage formats encompasses the whole value chain, including Formulation Development & Process Design, Analytical Development, Scale-up, Manufacturing, Packaging, Serialization and Aggregation.

Skyepharma also provides a range of support services that help client companies from early stage development (up to phase III), through scale-up and full commercial manufacturing and packaging to market introduction, including controlled substance handling, QbD methodology (FMEA, FTA, DOE), Troubleshooting, regulatory services, validation, registration and warehousing services.

As an integrated CDMO, the company’s vision is to help solve healthcare industry complexity with a mission to provide a dedicated and results-oriented team to deliver advanced oral dosage services to the healthcare industry through state-of-the-art facilities, scientific expertise and open, transparent relationships. All of this is summed up in its strapline: ‘Expert and Agile CDMO partner for tailor-made solutions’.