Homeopathic Manufacturing GMP Issues
Importance of compliance & testing
This is a story about a homeopathic manufacturer that was cited for several GMP issues, and about a discarded “sticky note” containing an out-of-trend result that was not properly investigated. Let’s see what we can learn.
Homeopathics are largely manufactured as drugs (CFR 211), which have a higher level of compliance than supplements (CFR 111), but there are still many learning lessons here.
Infant and toddler products are highly scrutinized. One reason is that young children are more susceptible to microbial and other contaminants, so extra precautions should be taken to ensure these products are safe.
From warning letter. “You manufacture homeopathic drug products including those labeled for children as young as two years old. You released drug products…. without adequate testing for critical microbial attributes (e.g., total microbial count, absence of objectionable microorganisms).”
The sticky note:
Unfortunately, this is no laughing matter, as FDA cited the company for also inadequately disposing of printed and signed cGMP documentation. This also includes a “sticky note” showing potential issues that were not investigated. Wow!
From warning letter. “For example, you inadequately retained and disposed of CGMP documentation including manufacturing records printed and signed by your QU as well as finished product specifications forms. Notably, a handwritten sticky note indicating an “out-of-trend” result with a quality determination was discovered among the discarded materials, yet this deviation was neither properly documented at the time of performance nor adequately investigated.”
Skip lot testing is not always okay, especially for microbial testing of drug products for young children.
From warning letter. “Rather than testing every batch, you conducted … tests on some of your batches of homeopathic drug products. Moreover, you did not conduct microbial testing before release for your … drug products.”
Expiration dating must have supporting data. This makes it seem as if they did not have supporting data for shelf-life extension, which is scary when the products are for young children.
From warning letter. “You extended expiration dates for … drug product without adequate stability data to support these changes. For example, you extended the shelf life … despite your stability data only supporting a … month shelf life.”
There is much more to this warning letter. I suggest giving it a read.
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