Dear Pharmaceutical Excipient Suppliers’ Auditors and Auditees,
You are cordially invited to attend one of the next 2-day EXCiPACT™ AUDITOR TRAINING COURSES in BRUSSELS on either 16/17 July, 2012 or 18/19 July, 2012.
Course Objective: Working knowledge of the EXCiPACT™ GMP and GDP standards
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NSF-DBA cherche un ou plusieurs Consultants associés indépendants pour proposer nos services en conseil pharmaceutique, en audit et en formation pour nos clients francophones.
Les candidats choisis, seront indépendants, avec de l’expérience professionnelle pharmaceutique, peut-être même avec l...
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Please be aware that Q11 received step 4 approvals from the ICH steering committee on 24 April. The final step 5 is implementation by the national/regional authorities and this is expected to occur within the next 6 months.
The step 4 version has not yet been published on the ICH website.
Be...
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In late March 2012 the EMA issued the final version of CHMP note for guidance (NfG) on Guideline on Real Time Release Testing (RTRT). This is new guidance replaces the previous guidance on parametric release (CPMP/QWP/3015/99) from 1 October 2012. The previous guidance only applied to the releas...
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Dear All,
In late March 2012 the EMA published a draft CHMP Guideline on Process validation that proposes to replace the existing CHMP Guidance’s on this topic (CPM/QWP/848/96 and EMEA/CVMP/598/99). Comments on this proposal are due to EMA by 31 October 2012. Unlike the ...
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