MHRA – Page 157 – Pharma.Tips

Design Controls Deficiency during EMA/MHRA review: what inspectors expect and how to fix it

Addressing Design Controls Deficiencies during Regulatory Reviews: Insights and Solutions In the highly regulated pharmaceutical industry, compliance with design controls is essential during product development and manufacturing. A deficiency related…

Software Validation Gap during EMA/MHRA review: CAPA plan with effectiveness checks

Addressing Software Validation Gaps During EMA and MHRA Reviews: A Practical Investigation Guide In the highly regulated pharmaceutical industry, software validation is a critical component ensuring product quality, compliance, and…

Finished product impurity increase on stability after process parameter adjustment: risk assessment for patient impact and field alert / recall triggers

Assessing Impurity Increases in Finished Products Post Process Parameter Adjustments In pharmaceutical manufacturing, the integrity of finished products is paramount. An increase in impurities during stability studies following adjustments to…

Aseptic manipulation deviation during ATMP manufacturing: regulatory risk assessment and CAPA

Assessing Aseptic Manipulation Deviations in ATMP Manufacturing: A Methodical Approach Aseptic manipulation deviations during Advanced Therapy Medicinal Product (ATMP) manufacturing pose significant challenges to regulatory compliance and product integrity. These…

E&L Failure during inspection preparation: device qualification and assembly controls

Addressing E&L Failures during Device Qualification and Assembly Controls In the pharmaceutical industry, ensuring the safety and efficacy of inhalation and nasal dosage forms is critical, especially during inspection preparations.…

Risk Management File Gap during lifecycle management: risk assessment and change control template

Addressing Risk Management File Gaps during Lifecycle Management in Pharmaceutical Manufacturing In the dynamic world of pharmaceutical manufacturing, ensuring robust risk management throughout the lifecycle of a product is paramount.…

Assembly Process Validation Failure during PAI readiness: risk assessment and change control template

Assessing Assembly Process Validation Failures in PAI Readiness: An Investigative Approach Within the pharmaceutical manufacturing landscape, assembly process validation failures can severely impede the readiness for a Pre-Approval Inspection (PAI).…

Finished product microbial limits failure after scale-up to commercial equipment: how to defend specification setting and outlier handling during inspection

Managing Microbial Limits Failures in Finished Products Post Scale-Up Microbial limits failures can present significant challenges in pharmaceutical manufacturing, especially when transitioning from laboratory to commercial-scale production. Such failures not…

Tag: MHRA

Design Controls Deficiency during EMA/MHRA review: what inspectors expect and how to fix it

Software Validation Gap during EMA/MHRA review: CAPA plan with effectiveness checks

Finished product impurity increase on stability after process parameter adjustment: risk assessment for patient impact and field alert / recall triggers

Aseptic manipulation deviation during ATMP manufacturing: regulatory risk assessment and CAPA

E&L Failure during inspection preparation: device qualification and assembly controls

Risk Management File Gap during lifecycle management: risk assessment and change control template

Assembly Process Validation Failure during PAI readiness: risk assessment and change control template

Finished product microbial limits failure after scale-up to commercial equipment: how to defend specification setting and outlier handling during inspection

Cryopreservation failure during tech transfer: regulatory risk assessment and CAPA

Cascade Impactor Setup Error at stability pull: device qualification and assembly controls

Design Controls Deficiency during tech transfer: risk assessment and change control template

Stability Failure after device supplier change: what inspectors expect and how to fix it