FDA Modernizes Inspections: Alternative Tools Accelerate Drug Approval
The FDA (Food and Drug Administration) has finalized its guidance on using alternative tools for routine inspections of drug manufacturing facilities. The measure aims to optimize the new product approval process by using remote methods to assess compliance with Good Manufacturing Practices (GMP).
Japan’s PMDA implements Surprise GMP inspections at manufacturing facilities
On July 2021, Regulators in Japan announced they will start conducting inspections by surprise at facilities where drugs, pharmaceuticals and medical devices products are manufactured
Brazil’s Anvisa is accepted into International API Inspection Program
Anvisa is accepted as a member of the international API Inspection Programs.
Japan’s PMDA Remote Inspections
The PMDA clarifies its requirements for conducting remote compliance inspections related to drugs and regenerative medical products.
TGA’s expectation on hosting remote inspection during COVID-19 pandemic
Therapeutic Goods Administration (TGA) publishes the Good Manufacturing Practices (GMP) approach for oversees manufacturers to assist manufacturers who may undergo remote inspection.
Brazil’s ANVISA successful implementation of the Medical Device Single Audit Program (MDSAP)
Brazil implements successful Medical Device Single Audit Program (MDSAP) and shows exciting results for the future of international inspection.