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Tag: 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 approved for Pharmaceutical Inspection Co-operation Scheme – PIC/S

Brazil’s ANVISA has completed the process of joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The Agency will become the 54th member of the international pharmaceutical inspection initiative.

Good Manufacturing Practices Certificate (CBPF) Renewal with Brazil’s Anvisa

Every Two years in Brazil, Manufactures must renew their GMP certificate known as CBPF, incorrect petition of this renewal will lead to rejection or return.

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.

China’s NMPA Publishes the “Cosmetic Supervision and Administration Regulation”

On June 29,2020 The National Medical Products Administration (NMPA) published a new cosmetic regulation known as the “Cosmetic Supervision and Administration Regulation”.

EMA waives GMP inspection fees during COVID-19

EMA waives GMP inspection fees during COVID-19

EMA announces GMP inspection fees will be waived fully for sites that undergo remote inspections during COVID-19 pandemic.

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