JD Supra

EU - US mutual recognition of GMP inspections: agreement published

On 4 March 2017, the agreement between the EU and the US governing the reciprocal recognition of GMP inspections of manufacturing sites for medicinal products for human use was published in the ...
JD Supra

Dutch authorities to focus on computerised systems during GMP inspections

The Dutch authority carrying out GMP inspections, the Health and Youth Care Inspectorate (IGJ), announced it will carry out a series of ...
PharmTech

Inspecting GMP at a Distance

The success of virtual GMP inspections performed during the pandemic may lead to more flexible opportunities in the future. A temporary system, under which good manufacturing practice (GMP) ...
Yahoo Finance

BioDlink Clinches Brazil GMP Audit to Strengthen Emerging Markets Growth

SUZHOU, China, May 21, 2025 /PRNewswire/ -- BioDlink has achieved a significant milestone in regulatory compliance after successfully passing an on-site GMP inspection conducted by Brazil's National ...
Nasdaq

WuXi Biologics Successfully Completed Pre-License Inspection and Routine GMP Inspection by U.S. FDA

WUXI, China, April 6, 2021 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, today announced that it has successfully ...
Royal Society of Chemistry

Management of GMP inspections

It is very important for pharmaceutical companies to plan carefully for all Good Manufacturing Practice (GMP) inspections, as a successful outcome is required for continued operations. Careful ...
FierceBiotech

WuXi PharmaTech Passes EMEA Inspection of Its GMP Manufacturing and Analytical Testing Facilities in Shanghai

SHANGHAI, China, Feb. 23 /PRNewswire-Asia/ -- WuXi PharmaTech ( WX), a leading pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China ...
BioWorld

CFDA zeroes in on quality, but conducted fewer GMP inspections in China

HONG KONG – Aiming to address a perceived disparity in the quality of manufacturing of drugs for the China market, the CFDA is ramping up its focus on offshore drug manufacturers. The regulator last ...
Nasdaq

WuXi Biologics Completes GMP Inspection by Health Canada for Drug Substance Facility

WUXI, China, Oct. 27, 2021 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, announced that it has completed a remote GMP ...
Yahoo Finance

PolyPid Successfully Completes Israeli Ministry of Health GMP Inspection, Advancing Towards Commercial Manufacturing Readiness for D-PLEX₁₀₀

PETACH TIKVA, Israel, Sept. 16, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today announced ...
Hosted on MSN

FDA 510(K) Approved Facilities: Increasing GMP Inspections And Compliance Requirements

Indian medical device manufacturers are enhancing their Good Manufacturing Practice (GMP) compliance, reinforcing India's role as a trusted global supplier in the healthcare and MedTech sectors. This ...