raw materials – Page 26

Unapproved material substitution during regulatory inspection – inspection questions regulators ask

Addressing Unapproved Material Substitutions in Pharma: A Practical Guide for Inspection Readiness Pharmaceutical manufacturing is fraught with complexities, particularly regarding raw material management. One of the most critical issues that…

Supplier audit findings escalated during regulatory inspection – supplier risk classification strategy

Investigating Supplier Audit Findings Raised During Regulatory Inspections When regulatory inspections reveal discrepancies related to supplier audits, it necessitates a structured investigation to determine the underlying causes. This article is…

Raw material change implemented without assessment during deviation investigation – CAPA to prevent repeat failures

Managing Raw Material Changes: A Playbook for Effective Deviation Investigations The pharmaceutical manufacturing landscape demands strict adherence to guidelines and regulations, particularly when it comes to handling raw materials. One…

Critical supplier risk not assessed during supplier onboarding – how to prevent repeat supplier failures

Preventing Recurrence of Supplier Failures: Investigating Critical Risk Assessment Gaps In today’s complex pharmaceutical landscape, ensuring the right risk assessments are performed during supplier onboarding is crucial to maintaining product…

Supplier change not evaluated during regulatory inspection – risk-based change impact assessment

Risk-Based Change Impact Assessment for Supplier Changes in Pharma Manufacturing In an environment where compliance is paramount, pharmaceutical manufacturers must remain vigilant regarding supplier changes. When a supplier change is…

Audit response ineffective during supply disruption – inspection questions regulators ask

Understanding Ineffective Audit Responses During Supply Disruptions: A Practical Investigation In the dynamic landscape of pharmaceutical manufacturing, supply disruptions can lead to significant challenges in maintaining compliance and production integrity.…

Change impact underestimated during deviation investigation – risk-based change impact assessment

Strategies for Managing Underestimated Change Impact in Pharmaceutical Deviations In the fast-paced world of pharmaceutical manufacturing, effective change control practices are paramount. Deviation investigations often reveal underestimated impacts of changes,…

Quality agreement gaps during regulatory inspection – how to prevent repeat supplier failures

Addressing Gaps in Quality Agreements During Regulatory Inspections: A Focused Investigation Quality agreement gaps can lead to significant compliance issues during regulatory inspections, disrupting the supply chain and impacting product…

Raw material change implemented without assessment during post-approval change review – risk-based change impact assessment

Mitigating Risks from Unassessed Raw Material Changes Post-Approval In the pharmaceutical manufacturing landscape, compliance with regulations and rigorous documentation are paramount. A frequent challenge faced by professionals is the implementation…

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