Section ECONOMY
TOPIC

SYMETAL S.A.

Application of GMPs (Good Manufacturing Practices) for the production of primary packaging materials for pharmaceutical preparations

The objective of the project is to produce primary packaging materials for pharmaceutical applications using best production techniques in a controlled environment which will ensure that the finished product is fully harmonized with the strict standards of the pharmaceutical industry and will continually cover the ever-increasing customers’ demands.

Symetal has determined all the necessary requirements for proper and uninterrupted operation of all processes required to ensure that packaging materials produced for pharmaceuticals are in accordance with Good Manufacturing Practice (GMP) principles.

Through the implementation of good manufacturing practices, Symetal ensures its business continuity and its continuous improvement in a highly competitive environment.

The principal recipients of these practices are large pharmaceutical companies, which require from their suppliers (mainly printers who are supplied by Symetal) to apply Good Manufacturing Practices (GMPs) to their business and then the final consumers who need and have the expectation to use safe pharmaceuticals.

2017-2018

GMPs followed by Symetal focus on the following areas:

Production

  • In production, emphasis has been placed on traceability issues related to raw materials by using specialized electronic systems to monitor their trace within the factory. In addition, controlled areas were created within the production of blister. Controlled areas have been created in order to avoid incidents which could cause material contamination.
  • Risk management procedures were established in production areas using tools such as the F.M.E.A.
  • In the field of quality control and especially of raw materials, emphasis was placed on the proper design of the quality control procedures.

Infrastructure

  • Introduction of new production equipment, which is now compatible with best production techniques, having an impact on the level of production and on the improvement of quality in all stages.
  • Use of cleaning and disinfection programs for all production sites and equipment to avoid contamination. At the commencement of production of packaging material for medicinal products in particular, full and clear separation of the line from previous production (line clearance) is required.

Human resources

  • Trained personnel specialized in production methodologies for materials intended for pharmaceutical preparations.

Quality Assurance

  • Quality control at all stages of production
  • Using statistical tools to analyze failures
  • Follow-up of corrective actions and check on the effectiveness level
  • Controls management

Business performance improvement

  • Process mapping using latest techniques
  • Adoption of Key Performance Indicators (KPIs) in business processes

Symetal collaborated with Q.A.C.S Ltd in order to get support for the design and implementation of GMPs, as well as with Bureau Veritas as an external organization which certified all practices with the International Standard ISO 15378:2017 "MS (Quality Management System) for Medicinal Packaging Materials Suppliers with reference to GMP”.

In the implementation of the GMPs, all staff involved in the production of primary packaging materials for pharmaceutical preparations are adequately trained.

Symetal S.A. - Foil Converting Plant (╬ťandra, Attica - Greece)

The results from the implementation GMPs are summarized below:

  • Significant increase in Symetal's 2018 sales in primary packaging materials for pharmaceutical products (43% compared to the previous year), with an additional increase in 2019.
  • The production volume of the blister foil material in 2018 increased by 47% compared to 2017.

By implementing good manufacturing practices (GMPs), Symetal certifies its dynamic and strong presence in the pharmaceutical industry globally. The economic performance of sales (43% increase) and relative the increase in the market share, are only a part of the positive effects of the implementation of GMPs.