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ICH’s 2003 Vision of a Harmonized Quality Regulatory Approach that Fosters Innovation Continued to Take Form in 2023 and 2024

The ICH goal of evolving its quality guideline series to keep pace with and provide support for technological innovation has continued to be realized in 2023 and 2024.

The goal is not a new one for ICH but was clearly articulated back in 2003 in an overarching “Quality Vision” calling for the development of “a harmonized pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science.”

● PART I: Analytics Guidelines Q14 and Q2(R2)
● PART II: Viral Safety Guideline Q5A(R2)
● PART III: ICH Q1/Q5C Revision and Stability Evaluation

Week Ending May 17, 2024:
Featuring MHRA Inspector Watson on API & Excipient Findings

At the Joint Pharmaceutical Analysis Group (JPAG) conference on APIs and excipients held in London in late March, MHRA Lead Senior GMDP Inspector Trevor Watson shared his insights on current regulatory expectations and common inspection findings. He discussed: ● relevant UK and EU legislation for APIs ● inspection of API manufacturers ● API inspection findings between 2021-2023 ● GMP deficiency themes ● inspections of UK and overseas dosage form manufacturers ● common deficiencies in control of starting materials, and ● MHRA compliance referral processes.

 

Updates in Brief

FDA Drug Recalls

FDA Warning Letters

EMA NCRs

IPQ’s meeting schedule through September includes:

JUNE

JULY

AUGUST

SEPTEMBER

PDA Digitalization Conference
(June 4-5) Antwerp, Belgium

PDA Medical Device Conference
(June 4-5) Antwerp, Belgium

USP Dietary Supplement and Herbal Medicine Forum
(June 5) Rockville, MD

DIA Southeast Europe (SEE) Conference
(June 5-6) Zagreb, Croatia

RAPS Regulatory Intelligence Conference
(June 5-7) Baltimore, MD

PDA AI Workshop
(June 6) Antwerp, Belgium

CASSS CGTP Summit
(June 10) Rockville, MD

EDQM 60th Anniversary Conference
(June 11-12) Strasbourg, France

CASSS CGTP Symposium
(June 11-13) Rockville, MD

DIA Global Annual Meeting
(June 16-20) San Diego, CA

ISPE Biotechnology Conference
(June 17-18) Boston, MA

PDA ATMP Conference
(June 24-25) Amsterdam, Netherlands

PDA Virus Conference
(June 26-27) Amsterdam, Netherlands

IPA Global Pharmaceutical Quality Summit
(June 27-28) Mumbai, India

PDA Next Gen Sequencing Workshop
(June 28) Amsterdam, Netherlands

PDA CGT Pharmaceutical Conference
(July 10-11) Tokyo, Japan

CASSS CMC North America
(July 16-17) Gaithersburg, MD

USP CM Workshop
(July 18-19) Rockville, MD

CASSS CMC Latin America
(Aug 6 and 13) Virtual Only

CDER BLA Submission Meeting
(Aug 20) Washington, DC

IPAC-RS Inhaled Biologics Workshop
(Sept 4-5) Washington, DC

PDA Manufacturing/Legislation Workshop
(Sept 4-6) Berlin, Germany

PDA/FDA Joint Regulatory Conference
(Sept 9-11) Washington, DC

PDA GMP Comparison Workshop
(Sept 11-12) Washington, DC

CASSS Pharm
(Sept 15-18) Costa Mesa, CA

PDA Biomanufacturing Conference
(Sept 24-25) Gothenburg, Sweden

IPEC Europe
(Sept 24-25) Vienna, Austria

PDA Sustainability Workshop
(Sept 26) Gothenburg, Sweden

IPQ would like to thank our partners: