Simplified Chinese
The Pakistan Drug Regulatory Authority has visited Minhai to conduct an inspection of the leprosy bivalent vaccine.
Release date:
2018-12-29
Author:
International Cooperation Department, Wu Yuan
Source:
Abstract
Recently, a five-member delegation comprising two inspectors from the Pakistan Medicines Regulatory Authority—Abdul Rashid Shaikh and Muhammad Amin—and three agents, including Shahzad Hussain Chaudhry, visited Minhai to conduct an inspection of the measles–rubella combined attenuated live vaccine (hereinafter referred to as the “MR vaccine”). Company executives attached great importance to this inspection by the Pakistan Medicines Regulatory Authority, instructing all levels of the organization to take it seriously, provide full cooperation, and make thorough preparations to ensure the smooth completion of the inspection.
Vice Presidents Li Xiangqun and Nie Xiaoqi, leading representatives from the International Cooperation Department, QA, QC, repackaging, and other departments, extended a warm welcome to the inspectors from Pakistan’s Drug Regulatory Authority. Vice President Li stated that colleagues across all departments would fully cooperate in preparing for the inspection by the Pakistani regulatory authority, and expressed hope that this review would help identify and progressively narrow the gap between the company’s practices and international standards, thereby ensuring the quality of Minhai’s leprosy‑diphtheria combined vaccine.
Inspector Abdul Rashid Shaikh expressed great pleasure at visiting Minhai to conduct the inspection of the leprosy‑diphtheria combined vaccine, commending the meticulous preparations made by Minhai for this visit. Over the next two days, he will rigorously evaluate Minhai’s leprosy‑diphtheria vaccine in accordance with stringent standards, ensuring that the product meets all regulatory requirements for registration in Pakistan and ultimately bringing high‑quality vaccines to the Pakistani market.
Following two days of intensive inspections, two inspectors from Pakistan’s Drug Regulatory Authority conducted on-site assessments of Minhai’s finished‑product warehouse, raw‑and‑auxiliary‑materials warehouse, measles–rubella bulk‑vaccine production workshop, sub‑packaging workshop, water‑production facility, and QC laboratory. They also carried out a thorough review of the relevant production and quality‑management documentation for Minhai’s measles–rubella bivalent vaccine.
Following two days of intensive inspections, we deeply admire and commend the Pakistani drug regulatory authority’s inspectors for their responsible and diligent work. Minhai will seize this opportunity to set even higher standards for itself, striving to obtain registration approval for its measles–rubella bivalent vaccine in Pakistan in 2019, thereby opening up the Pakistani vaccine market and bringing Minhai’s measles–rubella bivalent vaccine to the people of Pakistan.
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