Whereas PIC/S Guide PE 009 applies to industrial manufacture of distributed medicinal products, the basic requirements presented in this Guide apply to the preparation of medicinal products normally performed by healthcare establishments

Guidance on GMP of medicinal products for human use prepared in healthcare establishment.

Appendix 1 provides guidance on the classification of the urgency of the recall of defective medicinal products. Class I defects are potentially life threatening. A Rapid Alert notification must be sent to all contacts of the rapid alert notification list, irrespective of whether or not the batch was exported to that country.

2017年7月5日 · This procedure covers transmission of information by means of a Rapid Alert between the different parties relating to the recall of medicinal products which have quality defects, including counterfeit or tampered products, when urgent action is required to protect public health and animal health.

To achieve this quality objective reliably there must be a comprehensively designed and correctly implemented Pharmaceutical Quality System incorporating Good Manufacturing Practice and Quality Risk Management. It should be fully documented and its effectiveness monitored.

PI 010-4 Page 3 of 9 1 January 2011 2.5 In the present document party means Competent Authorities which are covered by a bilateral or a multilateral agreement, such as MRA partners, PIC/S authorities or MoU partners. 2.6 This SOP is in line with the EU document “Procedure for Handling Rapid Alerts

2024年3月1日 · The Guide is divided into two parts with 20 annexes. The annexes provide detail on specific areas of activity. For some manufacturing processes, different annexes will apply simultaneously. Guide to Good Manufacturing Practice for Medicinal Products - …

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Whereas PIC/S Guide PE 009 applies to industrial manufacture of distributed medicinal products, the basic requirements presented in this Guide apply to the preparation of medicinal products normally performed by healthcare establishments for direct supply to patients. At the time of issue this document reflected the current state of the art. It is