Innovation and Continuous Improvement in Pharmaceutical Manufacturing

Continuous improvement is an essential element in a modern quality system and it aims at improving efficiency by optimizing a process and eliminating wasted efforts in production. In the current system continuous improvement is difficult, if not impossible. Reducing variability provides a "win-win" opportunity from both public health and industry perspectives, therefore continuous improvement needs to be facilitated.

Depending upon the criticality of the change, some changes may even affect the safety, identity, strength, quality, or purity of the product. Others may trigger the need for new regulatory filings. Managing all this change is perhaps the most important part of any life-sciences quality program.

Our change-management system typically comprises the following essential phases in its development.

  • Initiation: Once the need for a change is identified, the person who suggested that change should formally draft a proposal for implementing the change. The proposal must define the change clearly and specify the reasons why it should be implemented. This proposal should be reviewed and approved by the head of the initiator’s department before it proceeds further.
  • Evaluation Cross-functional teams formally review all proposed changes for the impact that they may have on the state of control as well as the regulatory filing status. Most companies have formal change-management boards or committees to evaluate the changes. While quality assurance and regulatory affairs departments are the most important members of such boards/committees, validation, manufacturing, and engineering are also typically involved in evaluating the change proposals.
  • Involving the business side Depending upon the nature of the change, even the marketing, legal, and commercial departments may also be required to evaluate certain changes. The change-management board/committee evaluates all changes to determine whether or not to proceed. After a change is approved for implementation, the committee/board also formulates the change implementation action plan. Taking various actions might be necessary to ensure that the change succeeds in achieving the intended purpose while simultaneously preventing unintended
  • Tracking A manual or electronic documentation system is essential for any change-management system to efficiently track not only the implemented changes, but the data and documentation that must be generated to support them. Appropriate documentation must support regulatory filing status and a continued state of control, and should allow for full traceability. The supporting documentation should also include data generated to verify the effectiveness of any change after it has been implemented, as well as training records associated with the change implementation.
  • Training All employees involved with the initiation, evaluation, and implementation of changes must be trained on the change-management procedure. Records for the training required by the change-management procedure must be appropriately maintained. Furthermore, implementation of some changes may also require some re-validation and revision of such controlled documents as standard operating procedures and batch records, which may necessitate additional training. Effective training and the documentation of that training are essential for the overall success of the change-management system.