Could a R&D (analytical or formulation) personnel avoid wearing cap? what should be then the dress code for R&D? Is R&D a non GMP complied area?

R&D Dress code according to GMP.

R&D is usually regarded as not GMP-compliant since R&D batches are not to be marketed, so no patient risk. It is however useful to take your GMP regime into account before you start upscaling process to verify the intended process can actually be run under GMP conditions.
Dress code is based on risk assessment, also consider any health risk the product poses to your personnel.


Yes you are right RnD comes under non- GMP area if they are producing or testing medicamen non-human consumption. Apart from patients risk other risk i.e. r&d representative health risk, environment etc need to consider at r&d level. Dress code is internal decision but I would suggest if medicament contains biological, hormonal, antibiotics, anticancer etc need a extra precaution during development activity at r&d center too.


Thank you for your response.