We are at your disposal to interpret this warning letter and guide you all the way through the process. In this letter FDA declares that it has identified several violations and recommends you strongly engaging a consultant qualified as set forth 21 CFR Part 211 to assist your firm in meeting cGMP requirements.
Author Archive for: BKB TASARIM
About BKB TASARIM
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Entries by BKB TASARIM
Regula is seeking highly competent and experienced GXP auditors for its growing team. Job Summary: The successful candidate will be responsible for preparing, conducting, reporting GXP related Audits such as API, Excipient, Packaging Material Manufacturer & Supplier, Sterile/ Non-Sterile Medicinal Product Manufacturing Facilities, Data Integrity, Good Distribution Practices & Good Storage Practices according to Local and […]