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The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are two international instruments between countries and pharmaceutical inspection authorities. The PIC/S is meant as an instrument to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the ...
In countries that are part of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), the same role may be termed responsible person (RP) or authorized person (AP).
Pharmaceutical Inspection Cooperation Scheme: GMP Guides; World Health Organization GMP Guidelines; European Union GMP Guidelines; US CFR Title 21 parts 210 (GMP, general), 211 (GMP, finished pharmaceuticals), 212 (GMP, positron emission tomography drugs), 225 (GMP, medicated feeds), 226 (GMP, type A medicated articles).
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The Pharmacy Council of Nigeria (PCN) is an agency of the federal government of Nigeria, established in 1992 to regulate and control the practice of pharmacy in Nigeria. [1] [2] Its responsibility is to oversee the practice of pharmacy across the country and supervise pharmaceutical education in Nigeria.
The firms that are overdue for safety and quality inspections represent about 42% of the 4,700 plants that are currently registered to produce drugs for the U.S. and previously underwent FDA ...
The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).
SANAS was also recently elected to host the secretariat for the newly established African Accreditation Cooperation (AFRAC), launched in support of an African technical infrastructure under the African Union. SANAS is a founding signatory of the International Laboratory Accreditation Cooperation (ILAC) and International Accreditation Forum (IAF ...