Change control is a planned approach in which you try to plan out and control changes made to a product or a system as effectively as you can. The gist of change control is avoiding any unnecessary alterations and to document all the modifications that were made.

The standard operating procedures for change control management include the following:

  • Discipline: This defines the requirements to ensure changes to systems, processes, products and documents that could impact product quality are evaluated, documented and approved before the implementation and closure.
  • Scope: this standard operating procedure applies to, but is not limited to changes that could impact:
    • Product quality.
    • Product Shelf-life extension/reduction.
    • Production, packaging, labeling, and specification/intermediates shipped as final drug products.
    • Standard Operating Procedure, specification/methods for biological products, analytical test procedure/analytical templates, stability protocol/stability templates.
    • Approved validation document.
    • Planned preventive maintenance of equipment.
    • Any modification, which is planned for the alteration, deletion, and up-gradation, and repair, replacement of equipment, facility, area, or utility.
    • Material utilities, equipment, instruments, engineering drawings, design, made by pharmaceutical manufacturing unit.
  • Responsibility: quality head/designee shall be responsible for
    • Implementing and managing a system for the change control process.
    • Ensuring all aspects of the change control process are in order.
    • Obtaining the necessary information from other organizational units to comprehensively evaluate the potential impact of the changes on other sites as appropriate.
    • Provide the notification of changes to regulatory affairs, customers and market representatives.

For more information on Change Control, please read: What is Change Control? and Why is Change Control important?

Change Control SOP Example

Download Change Control SOP Template