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The pharmaceutical industry in Pakistan was estimated to be worth Rs. 748 billion (US$2.6 billion) in 2023, representing about 1% of the country's GDP. [1] The industry is largely import-dependent, with more than 90% of raw material being imported and only 12% of active pharmaceutical ingredients locally produced. [1]
The Pakistan Standards & Quality Control Authority (PSQCA; Urdu: مختاریہَ پاکستان برائے انضباطِ کیفیات و معیارات) is an autonomous body subordinate to the ministry of science and technology of the Government of Pakistan. Its main objective is to regulate and enforce quality standards in Pakistan ...
The Drug Regulatory Authority of Pakistan (DRAP) is a self-governing entity under the Federal Government of Pakistan. It functions under the administrative supervision of the Ministry of National Health Services, Regulations & Coordination .
The Drug Regulatory Authority of Pakistan was established in 2012 and is the largest department in the Ministry of National Health Services, Regulation and Coordination, with its headquarters in Islamabad and regional offices in the provincial capitals of Karachi, Lahore, Peshawar and Quetta. DRAP has been established by the Federal Government ...
Weichel (2004) recently found that over twenty warning letters issued by the FDA to pharmaceutical companies specifically cited problems in Computer System Validation between 1997 and 2001. [8] Probably the best known industry guidance available is the GAMP Guide, now in its fifth edition and known as GAMP5 published by ISPE (2008). [9]
The Pharmacy Council of Pakistan (ہیئتِ دواسازی پاکستان); acronym PCP) is a professional body for accreditation of pharmacy education and regulation of pharmacy profession in Pakistan. [1] It was established under Pharmacy Act, 1967 to protect, promote and maintain the health, safety and wellbeing of patients and the public ...
Process performance qualification protocol is a component of process validation: process qualification.This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process.
QA/QC is the combination of quality assurance, the process or set of processes used to measure and assure the quality of a product, and quality control, the process of ensuring products and services meet consumer expectations.