Change Control.
Ensuring compliance and safety in changing situations.

What is Change Control?

Change Control in the pharmaceutical sector is a principal element in any Quality Assurance system to maintain regulatory compliance, appropriate standards, or requirements throughout the entire lifespan of a drug or procedure.

It follows a regulated set of actions designed to oversee alterations to processes, systems, or documents that could influence the efficacy and safety of a product. Change Control processes apply to all GxP areas, and especially by their nature Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).

The objective of Change Control is to guarantee that a modification does not deviate from the intended process outcome and complies with all quality requirements associated with the particular product or process. This requires companies to carefully assess, authorize, execute, and document all modifications in a regulated manner.

Alongside compliance obligations, this is also to maintain product quality, minimize any potential risks, and ensure that alterations are well-justified, reducing any disruptions to operations.

Click here for more information from the European Medicines Agency (EMA) on GCP Change Control compliance requirements.

Click here for more information from the EMA on GVP Change Control compliance requirements.

Click here for more information from the European Commission on GMP Change Control compliance requirements.

Click here for more information from the EMA on GDP Change Control compliance requirements.

Planned & Unplanned changes.

A strong change control process enables pharmaceutical companies to effectively manage diverse types of modifications, and this is closely linked to the methodology employed for Deviation & CAPA Management with types of change and risk assessment for planned and unplanned changes.

Planned changes are deliberate and pre-approved modifications conducted following a thorough evaluation and authorization within the change control process. These modifications undergo careful consideration, and their effects on product quality, safety, and compliance are assessed before being implemented.

An unplanned change is a modification that occurs unexpectedly, requiring immediate attention. These often result from events such as equipment failures, safety incidents, customer complaints, deviations from established procedures, and other events. Deviations are considered unplanned changes, and it is important to have a process in place for effectively managing deviations that impact product safety, efficacy, and quality.

Classifying changes.

Typically, changes are classified into three categories based on their likely impact:

Minor changes – involving slight modifications or enhancements that have a minimal impact on the eventual product, process, or system, e.g. altering the font size on product labels.

Major changes – evaluated as having a more substantial impact on the resulting product, process, or system e.g. altering the manufacturing process for a drug formulation.

Critical changes – modifications or alterations that require rigorous assessment, validation, or even regulatory approval. They can potentially have a significant impact on product quality, safety, or efficacy, e.g. changing the active ingredient in a pharmaceutical product.

Change Control step process.

The steps within the change control process are comprised of specific actions to manage modifications may differ based on the company and the category of change classification, but typically they will follow:

  • Initiate Change Request – usually with a form or other procedure to formalise the procedure and document it.
  • Perform Impact Assessment – to evaluate the potential impact of the change on product quality, safety, efficacy, and regulatory compliance.
  • Review Change Request – performed by assigned personnel with the relevant qualifications.
  • Approve the Change Request Plan – following the impact assessment and review, the responsible person approves or rejects the change request plan. Major or critical changes may require approvals from multiple people.
  • Implement Change – and verify that the necessary adjustments are made to processes, equipment, or documentation as required before approval for closure.
  • Provide Training – as applicable.
  • Monitor Change Effectiveness – conduct an effectiveness check to evaluate the impact and success of the implemented change.

Why choose Aegisana’s Change Control services?

Process driven.

Aegisana’s Compliance team is fully experienced with Change Control processes, best practices, and Deviation Management for all GxP areas, particularly for GMP and GDP situations.

Our rigorous process looks at many areas within Change Management and typically but not exclusively considers:

  • Which types of changes does the change control process consider, and to which areas does this operational instruction apply?
  • Who has the authority to suggest or initiate changes?
  • What methods or forms are used for requesting changes, and how is communication managed?
  • How are changes assessed and graded, and who holds the responsibility for the grading process?
  • How are the necessary measures for implementing changes determined, and who compiles the required instructions?
  • Who is accountable for executing and monitoring all essential measures?
  • How is the change control committee formed, and what are its responsibilities?
  • In what manner are changes documented, including the format, content, and storage procedures?
  • Who is responsible for granting authorization for changes?
  • What specific regulations govern urgent changes?

Confidence through experience.

We understand the importance of a defined Change Control process that is well-organised and documented, outlining the steps, responsibilities, and procedures clearly.

Our team provides a risk assessment for each proposed change to identify impacts and monitors all testing and validation for effectiveness checks.

Our objective is to provide you with peace of mind and confidence that comes from knowing your Change Management process is being handled by an expert team providing a systematic and detailed service grounded in effective communication, reliability, and trust.

Through the establishment of a successful and robust strategic compliance partnership, we aim to offer comprehensive support across all our service areas, providing expert solutions throughout the entire life cycle of your human and animal products.

All of our services adhere to the regulations and principles of the EMA’s guidelines on compliance.