A Peer-Reviewed Journal Focused on GMPs and Validation

January 2025

Featured Article

FEATURED BOARD MEMBER

Christopher V. Latoz, Stability Manager, Hollister Incorporated

Implementing ICH Q12 to Enhance the Stability Program
Kim Huynh-Ba*, Pharmalytik LLC, and
Christopher Latoz, Hollister Incorporated
*Corresponding Author

ABSTRACT
Pharmaceutical products require expiration dates and storage conditions on their labels, determined through stability studies conducted from clinical trials through post-approval. These studies ensure that any chemical, physical, or microbiological changes over time do not affect the product’s quality, safety, or efficacy. ICH Q1A(R2) provides guidance for stability programs but focuses on new drugs and lacks a comprehensive approach where prior stability knowledge can be applied...

Industry News

TRS 1052 - Annex 4: WHO Good Practices for
Pharmaceutical Quality Control Laboratories

The WHO published the TRS 1052 - Annex 4 on WHO Good Practices for Pharmaceutical QC laboratories on 04/2024, addressing the challenges in pharmaceutical production, including recommendations for improving global GMP harmonization. Training is available.

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Pharmaceutical Inspections and Compliance | FDA

The FDA most recent amendment seems to imply stricter oversight on quality control units and expanded testing for components and drug products. It emphasizes inspections using a risk-based model and focuses on biologic quality Standards.

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This Month's Dose of Knowledge

New Year, A More Connected You

By combining actionable goal planning with targeted professional development, you're setting a strong foundation for a productive and fulfilling year ahead.

Here are a few ideas to try as we kick off the new year!

Set SMART Goals: Craft goals that are Specific, Measurable, Achievable, Relevant, and Time-bound. This ensures clarity in your objectives and helps in tracking progress effectively.Set SMART Goals: Craft goals that are Specific, Measurable, Achievable, Relevant, and Time-bound. This ensures clarity in your objectives and helps in tracking progress effectively.

Accountability and Support: Share your goals with a mentor, coach, or accountability partner who can provide feedback and motivation.

Attend Workshops, Conferences, Webinars and Trainings: Participate in industry seminars, workshops, or conferences to gain new insights and networking opportunities.

Develop Soft Skills: Focus on building soft skills like communication, teamwork, problem-solving, and emotional intelligence.

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