Post-Approval Changes in Formulation Development
1) Purpose
The purpose of this SOP is to establish procedures for managing post-approval changes in formulation development, ensuring that changes to approved drug products are evaluated, implemented, and documented in accordance with regulatory requirements and good manufacturing practices (GMP).
2) Scope
This SOP applies to the management of post-approval changes for drug products within the formulation development department of the organization, covering changes to formulation, manufacturing processes, analytical methods, packaging, labeling, and specifications.
3) Responsibilities
The responsibilities for this SOP include:
Formulation Development Team: Assessing proposed changes, conducting impact assessments, and implementing change control procedures.
Regulatory Affairs: Providing regulatory guidance, submitting change notifications, and ensuring compliance with regulatory requirements.
Quality Assurance: Reviewing change requests, assessing impact on product quality, and approving change implementation plans.
Manufacturing Operations: Executing changes, updating documentation, and ensuring manufacturing processes align with approved changes.
Clinical Operations: Supporting changes affecting clinical trial materials and ensuring continuity in clinical studies.
4) Procedure
4.1 Change Proposal
- Initiate change request for proposed post-approval changes, including rationale, scope, and potential impact on product quality, safety, and efficacy.
- Document proposed changes in a change control form, specifying details such as change description, justification, and regulatory impact assessment.
- Obtain cross-functional review and approval of change proposal, including formulation development, regulatory affairs, quality assurance, and manufacturing stakeholders.
4.2 Impact Assessment
- Conduct comprehensive impact assessment of proposed changes, evaluating potential risks to product quality, regulatory compliance, and patient safety.
- Assess change impact on formulation characteristics, manufacturing processes, analytical methods, stability profile, packaging, labeling, and regulatory submissions.
- Document impact assessment findings and risk mitigation strategies to address identified risks associated with proposed changes.
4.3 Change Implementation
- Develop and implement change implementation plan, detailing steps for execution, timeline, responsibilities, and verification activities.
- Update relevant documents, including batch records, standard operating procedures (SOPs), specifications, and regulatory filings, to reflect approved changes.
- Ensure training of personnel involved in executing and monitoring changes to maintain consistency and compliance with updated procedures.
4.4 Documentation and Reporting
- Maintain accurate and complete documentation of post-approval changes, including change control records, impact assessments, implementation plans, and verification activities.
- Generate change control reports summarizing change history, implementation status, and compliance with regulatory requirements for review and approval.
- Submit regulatory notifications, variations, or supplements as required by applicable regulatory authorities to obtain approval for implemented changes.
5) Abbreviations, if any
SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
6) Documents, if any
Change Control Form
Impact Assessment Reports
Change Implementation Plans
Regulatory Notifications
7) Reference, if any
– FDA Guidance for Industry: Changes to an Approved NDA or ANDA
– ICH Q10: Pharmaceutical Quality System
8) SOP Version
Version 1.0
