European Pharmaceutical Review

FEBRUARY 22, 2023

Therefore, contamination control measures are tailored to the specific risks around each individual process. Dr Madina Karimova, Quality Assurance Manager at Sanofi shared her opinion on PDA’s TR 90 report, highlighting parts she found valuable.

Documentation 87

Documentation Pharmaceutical Manufacturing 87

European Pharmaceutical Review

AUGUST 25, 2023

The new guideline should help manufacturers gain clarity on how to benefit from new possibilities originating from the application of an enhanced process understanding by utilising innovative tools as described in the ICH guidelines Q9 and Q10. The former ICH guideline came into force on 26 July 2023.

Documentation 92

Documentation Pharmaceutical Manufacturing 92

pharmaphorum

JUNE 8, 2022

Driving a Holistic Approach to Assurance of Product Sterility through Aseptic Manufacturing following QRM Principles. Conference Chairman: James Drinkwater, Head of Aseptic Processing Special Interest Group PHSS and Head of GMP Compliance, F Ziel GMBH. Discover a risk-based approach to cleaning and disinfection. Process Leaders.

52

52

Express Pharma

JANUARY 6, 2024

The revised Schedule M includes the introduction of a pharma quality system (PQS), quality risk management (QRM), product quality review (PQR), and specific guidelines for the qualification and validation of equipment. It also mandates a computerised storage system for all drug products.

103

103

European Pharmaceutical Review

JANUARY 16, 2023

There is an expectation that more thorough, science-based quality risk assessments are developed and that these are ‘proactive’, in terms of looking for contamination risks before they occur. All require aseptic manipulation, hence have microbial contamination risks.

Vaccines 126

Vaccines Research Laboratories Documentation Compounding 126