Shilpa Medicare Limited FDA Warning Letter 2020 Delivery Method:VIA UPSProduct:Drugs Recipient:Mr. Vishnukant Chaturbhuj BhutadaManaging DirectorShilpa Medicare Limited #12-6-214/A1 Hyderabad RoadRaichur 584135 KarnatakaIndiaIssuing…
Sterility Testing is defined as a testing which confirms that products are free from the presence of viable microorganisms. Sterility…
Antimicrobial Effectiveness testing is described in USP <51>. Previously this chapter was known as “Preservative Effectiveness Testing”. Detailed procedure for…
A cleaning validation protocol format shall be developed for the ‘worst case’ product selected for cleaning validation programme. Following information…
Standard Operating Procedure (SOP) and Guideline for preparation, approval, and revision of Site Master File (SMF). The Site Master File…
Pfizer Healthcare India Private Limited Warning Letter 2020 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility,…
GUIDE TO INSPECTIONS OF HIGH PURITY WATER SYSTEMS Note: This document is reference material for investigators and other FDA personnel.…
Checklist for review of microbiology data generated during the different tests of microbiology i.e. Antibiotic Assays, Particulate matter test, BET…
A microbial culture (microbiological culture) is a procedure of growing microbial organisms (reproduction) by allowing them to breed in programmed…
LAF : Laminar Air Flow – Airflow which is linear and positive up to working surfaces and thus prevents contamination…