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Cleaning Validation – Your GMPs Depend on It

Cleaning Validation – Your GMPs Depend on It

Presented by Joe McGuinness, EAS Independent Consultant.  July 13, 2021 at 1pm eastern.  For FDA to require that equipment be clean prior to use is nothing new, with the main rationale to prevent contamination or adulteration of drug products. Per FDA’s...
Do You Have GMP Grief?

Do You Have GMP Grief?

EAS pharma expert, Joe McGuinness, published an article in Tablets and Capsules on coming to terms with the requirement of GMP implementation. While GMPs have always been required (in theory) for Active Pharmaceutical Ingredients (APIs), the FDA often found itself at...
Drug and Device Corner May 2021

Drug and Device Corner May 2021

With the Over-The-Counter Monograph User Fee Program (OMUFA) 2021 facility user fee now past due, the FDA would like to remind all drug establishment manufacturers to make payment immediately. Please note the FDA has not issued invoices for this fee. The agency’s only...