This article contains 20 Things Never to Say to an Auditors/FDA Investigator….. 20 Things Never to Say to an Auditors/FDA Investigator : 1. “I think…” 2. “I am not sure but [insert guess here]…”...
This article describes about the Minimum requirements in Warehouse for Oral solid Dosages forms as per Regulatory Requirements : Requirements in Warehouse for Oral solid Dosages forms : 1) Raw Material Store : a)...
This article describes for Vendor Audits/vendor qualification for Active Pharmaceutical ingredients (APIs), Excipients, Packing Material and evaluation of approved manufacturers of API’s, Excipients & Packing Material. Detailed procedure for Vendor Audits / Vendor Qualification....
This article describes about difference between Form FDA 483, Warning Letters and EIR and its systemic schematic flow chart for better understanding. What is mean by Form FDA 483 ? Form FDA 483 is...
This article Describes about Comprehensive Tips to face FDA Inspection/Audit, Types of FDA inspection, Do’s and Don’ts during FDA inspection, Types of Listening skills. What is mean by FDA Inspection/Audit ? In the pharmaceutical...
This article provide information about How to manage regulatory inspections i.e. How to welcome the auditor, How to communicate with auditors, How to answer the questions which will ask by auditors and closing meeting....
This article provided description and purpose about different types of FDA forms used during regulatory inspection for united state of America (US). Different Types of US FDA inspection forms provided during Regulatory Inspection Introduction...
