Quality Practices for Research and Development (R&D) CMC Laboratories March 28, 2013

This Quality Practices for R&D CMC Laboratories training will associate with generating, reviewing, utilizing or contracting analytical studies for pharmaceutical product development.

Why Should You Attend:

During product development, many experimental CMC studies to support process development and product characterization are conducted in non-GMP laboratories, including academic and contract facilities. However, the data generated in these studies may be utilized in product regulatory filings, making them subject to concerns about traceability and reproducibility. While there are no formal compliance requirements for R&D laboratories, emerging regulatory concepts in quality systems and quality by design place greater compliance pressure on R&D labs for sound scientific practices. Additionally, early-phase quality control testing may be performed in laboratories that are not fully GMP compliant, and are in fact much closer to R&D than GMP.

- A large number of CMC studies to support product development are not required to be performed in GMP laboratories.
- Data from supportive CMC studies are typically presented in regulatory dossiers which makes them subject to later review and verification.
- Lack of adequately documented early development data often becomes a cost factor for in-licensed products.
- Quality practices at academic and contract testing laboratories can greatly impact the utility of their CMC data.
- Some analytical laboratories erroneously interpret GLP as 'GMP-light'.

Areas Covered in the Seminar:

- What is the economical impact of poor quality R&D CMC data in product development timelines and costs?
- What laboratory studies are required to be performed under GLP vs GMP?
- What quality practices are expected for non-GMP/non-GLP laboratories - where the data generated are used in regulatory filings?
- What are the key-process related CMC activities.
- what are Key Analytical and QC CMC Activities.
- what is good CMC practices and how to ensure CMC quality is consistently implemented.