In January of 2011, the Health Products Regulation Group (HPRG) Health Sciences Authority (HSA) held a regulatory workshop on Good Manufacturing Practices for Medicinal Products Manufacturers. One session, conducted by the HSA’s Boon Meow Hoe, traced through the history, current applicability and future trends of PIC/S GMP. PIC/S History PIC/S has been at the forefront…
HISTORY of Chinese GMP guidelines Updated GMP guidelines were issued by the Chinese SFDA in February 2011, and went into force starting March 1st, 2011. This blog discusses historical changes in Chinese GMP guidelines and includes links to articles from the World Health Organisation (WHO). Chinese GMP updates from 2011 Chinese GMP vs…
What the requirements are and how to cost effectively comply The TGA’s code of GMP recommends that all suppliers be qualified – “The process of assessing the reliability of a supplier to consistently provide material of acceptable quality”. For complementary manufacturers with many, many suppliers, qualifying them all is an onerous and expensive exercise. For…
With the US FDA joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S), compliance with the PIC/S GMP standards should be a priority for any pharmaceutical manufacturer exporting to multiple countries. What is PIC/S? As described on the PIC/S website, the mission of the PIC/S organisation is ” “to lead the international development, implementation and maintenance of…
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