EMA – Page 187 – Pharma.Tips

Stability Failure after formulation change: regulatory-ready investigation and CAPA plan

Investigating Stability Failures Following a Formulation Change: An Actionable Approach In the dynamic environment of pharmaceutical manufacturing, formulation changes are often necessary to enhance product performance or adapt to regulatory…

Cpv Trending Gap for innovative delivery systems: decision tree for lab vs manufacturing root cause

Addressing the Cpv Trending Gap for Innovative Delivery Systems: A Structured Investigation Approach Pharmaceutical manufacturers are increasingly focused on the development and implementation of advanced delivery systems that aim to…

API photostability failure during tech transfer to a new site: how to write a defensible deviation narrative for inspections

Addressing API Photostability Failures During Technical Transfer: A Guide to Defensible Deviation Investigations In the realm of pharmaceutical manufacturing, the transfer of Active Pharmaceutical Ingredients (APIs) to a new site…

Sedimentation Oos during bulk hold: manufacturing vs lab root cause decision tree

Investigating Sedimentation OOS During Bulk Holds: Decision Paths for Manufacturing and Lab Situations In the pharmaceutical manufacturing realm, Out-of-Specification (OOS) results related to sedimentation during bulk hold can pose significant…

Ivivc Mismatch during tech transfer: how to document for FDA/EMA/MHRA review

Documenting Ivivc Mismatch during Technical Transfer for Regulatory Review Ivivc (In Vitro to In Vivo Correlation) mismatches during the technical transfer of pharmaceutical formulations can pose significant challenges for compliance…

Oos Release Profile for modified release platforms: decision tree for lab vs manufacturing root cause

Root Cause Analysis of OOS Release Profiles for Modified Release Platforms In the pharmaceutical manufacturing industry, issues surrounding out-of-specification (OOS) results related to modified release profiles can create significant challenges.…

Specification Justification Gap during lifecycle management: decision tree for lab vs manufacturing root cause

Addressing Specification Justification Gaps in Lifecycle Management: A Decision Tree Approach for Lab and Manufacturing Root Cause Analysis In the pharmaceutical industry, maintaining stringent quality standards throughout the product lifecycle…

API stability failure at accelerated conditions during stability pull at 6/12 months: supplier qualification gaps and incoming testing upgrades to close the loop

Addressing API Stability Failures at Accelerated Conditions: A Practical Investigation Approach In pharmaceutical manufacturing, stability failures of Active Pharmaceutical Ingredients (APIs) during accelerated conditions can pose significant risks to product…

Pet Failure after supplier change: GMP documentation for FDA/EMA/MHRA review

Investigating Pet Failures Following Supplier Changes: Strategies for Compliance and Quality Assurance In the ever-evolving landscape of pharmaceutical manufacturing, the stability and efficacy of products are paramount. However, changes in…

Cpv Trending Gap during PAI readiness: how to document for FDA/EMA/MHRA review

Understanding Cpv Trending Gaps for Successful PAI Readiness Documentation Pharmaceutical manufacturing is a precise and regulated industry, and any deviations or out-of-specification (OOS) occurrences can lead to serious compliance issues…

Oos Release Profile for innovative delivery systems: how to document for FDA/EMA/MHRA review

Documenting OOS Release Profiles for Innovative Delivery Systems: An Investigation Approach for Regulatory Review In the landscape of pharmaceutical manufacturing, particularly for advanced and novel drug delivery systems, Out-of-Specification (OOS)…

API hygroscopicity-driven degradation after solvent change in last step: data integrity and chromatographic audit trail review steps

“` Investigating API Degradation Due to Hygroscopicity After Solvent Change in Final Production Step In pharmaceutical manufacturing, the integrity of active pharmaceutical ingredients (APIs) is paramount. An incident may occur…