Packaging Strategy

Client: a well-known pharmaceutical multinational, operating in over 150 countries, engaged in the discovery and development of new medicines to provide innovative solutions for patients and doctors.

Sector: Pharmaceuticals

Objective: Qualification and validation of three blister packaging lines to replace five older packaging lines


The company had made significant investments in the production site in order to modernise the technologies of the packaging area in order to strengthen its production capacity.

The company decided to replace five of the older packaginglines by installing three new, modern lines, manufactured in Italy using the most advanced technology available in the sector

Even for such a solid company, replacement of technologies involves a huge effort both in terms of resources involved and the number of interventions to be carried out on the area, mechanical/electrical parts, documentation and management applications.

The activities required by a renovation project therefore include a number of operations and controls to demonstrate the correct operation of the equipment post installation.

All the above must take place in compliance with current regulations (GMP and safety standards).

The release of each packaging line also depends on the successful outcome of all the activities envisaged and planned by the project and on authorisation by AIFA (Italian Medicines Agency)

Our contribution

For the activities envisaged by the Packaging Strategy Project, the company chose to rely on the S4BT Qualification Team (equipment, environments and utilities).

The S4BT Team of Consultants carried out the following activities to renovate the packaging area:

  • Risk analysis on the packaging process using the FMEA methodology;
  • Drafting of process validation documentation (Drafting Packaging Validation protocols and collecting data via Validation Reports)
  • Drafting equipment qualification documentation (drafting of Performance Qualification protocols, compilation and execution of qualification tests, final data collection by issuing PQ Release

For the entire duration of the project, the S4BT Consultants cooperated synergistically with various areas of the client company including: Quality, validation, production, and engineering.


The Packaging Strategy Project for the new packaging lines was developed in three stages based on the introduction of sequential lines and considering the high number of products to be transferred to the new equipment.

This was made possible by simplifying the approach, grouping products with similar and comparable characteristics in homogeneous groups, and performing tests on ”worst case” products to cover less critical products.

The main results are listed below:

  • shorter test execution and line release times for the execution of the validation activities
  • the packaging lines were qualified and validated, allowing the client to release them and make them available for commercial production in accordance with the deadlines
    special attention was paid to intensive IPC sampling to ensure the quality of the packaging process and maintain high line performance standards


An aid to inspection work

Simplify the management of Complaints, from filing, through investigation, follow-up, judgment and final report.

The module is designed to provide step by step Quality Assurance support
in the implementation and supervision of the process and the assignment of tasks to the departments involved. The module supplements the CAPA procedure, which the user can open directly from the Complaints procedure.

PRAGMA-WFM documents and traces all activities and information in the Complaints process. In each phase, you can also attach files in various formats to support activities and investigations.

During inspection phases, the functionality dossier enables the real-time generation of a document that provides information and lists the activities of the process and related processes


Documents and traces activities

It simplifies the management of internal and external audits, from planning, through execution, to the management of remarks.

The module supplements procedures for handling CAPAs , Non Conformitiesand Change Control that the user can open directly from the audit to resolve the observations found.

PRAGMA-WFM documents and traces all activities and information of the Audit process. For each process step, it is possible to assign tasks to the people involved, and attach files in various formats.

Duringthe inspection phase, the dossierfunctioncan generate a document in real time which records the information and activities of the Audits and related processes