![]() ISO implementation has the advantage of auditing by a third party to determine the level of compliance, and formal certification once the level is acceptable. The Standard sets out the framework for a QMS that could be used by any industry that produces a product for a customer and as such, the requirements are general. The manufacture of fresh blood and blood components has also become highly regulated in many countries, with Codes of Good Manufacturing Practice written specifically for the industry.Ĭertification to the international Standard ISO 9001: Quality management systems – Requirements has been undertaken by a number of Blood Establishments in countries where regulation of the Blood Establishments has not yet been introduced. Part of this transition has been driven by the emergence of, initially, quality management systems (QMS), and subsequently, principles of good manufacturing practice (GMP) as requirements for blood establishments. Vee Armstrong Quality and Regulatory Consultant, Perth, Australiaīlood Establishments have undergone a significant cultural change over the past 25 years, moving from a predominantly scientifically focussed culture to that of a manufacturer of therapeutic goods. ![]() Indonesian Day 1A-S01-01 GMP vs ISO in A Blood Establishment
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