What is true about GMP in relation to investigational product coding and labeling?

• A. GMP applies to marketing products.
• B. GMP applies to manufacturing; coding and labeling protections for blinding.
• C. GMP is not relevant to IP.
• D. IP should be manufactured without GMP oversight.

Answer: (B)

GMP governs the manufacture and packaging of the investigational product to ensure its quality, safety, and consistency. When it comes to coding and labeling, GMP-backed processes protect blinding and traceability: the product is coded and labeled in a way that preserves the blind where required, while still providing essential information like the batch/lot number, expiration date, storage conditions, and the product name. This combination helps prevent mix-ups, ensures the correct product reaches the right participant, and allows for proper recalls or investigations if needed. So, GMP is about how the IP is manufactured and packaged, including how it is coded and labeled to support blinding. It does not apply only to marketing products, and IP must be manufactured under GMP oversight, not without it.