Question: please edit and correct the following: . If an SOP is created to improve processes to prevent non - conformance, such as implementing stricter temperature
please edit and correct the following: If an SOP is created to improve processes to prevent nonconformance, such as implementing stricter temperature monitoring during transit, this would be considered a significant change requiring a change control process. The change control process involves documenting the proposed change, assessing its impact on product quality and regulatory compliance, obtaining approval from relevant stakeholders, implementing the change, and documenting the results. In Canada, reporting requirements for such changes would depend on the specific regulations governing pharmaceutical manufacturing and distribution, and compliance would be ensured through regulatory inspections and audits.
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