Article archive

Who should review Batch Record?

17/10/2013 22:07
The Qualified Person (QP) often reviews the batch documentation personally prior to certification of the batch. But is the QP obliged to do so? No, it is not a requirement. Chapter 4 of the EU-GMP Guide states that "all records should be available to the Qualified Person" (4.27). It doesn't say...

Interesting APIC/CEFIC Guideline for the Qualification of Contract Laboratories

17/10/2013 22:04
Already some time ago, the APIC has published a guideline for the qualification of contract laboratories. Although this interesting Guide was already published in 2012 it is not well known in industry. The guideline is supposed to define uniform requirements for the "life cycle management" of...

WHO revises Guideline for Maximum Hold Times

17/10/2013 21:54
Already in spring 2013 the WHO had published a draft of a guideline for comments. This guideline lays down maximum hold times for starting materials, intermediates and bulk products. The WHO has now issued a revised version of the draft. The deadline for comments was extended from originally April...

FDA Inspection Reports: What are various results and their significance?

17/10/2013 21:51
Repeatedly I receive questions with regard to the various inspection reports of the U.S. Food and Drug Administration (FDA). Following will introduce the three main documents: Form 483 This form with the eponymous number 483 is used by the executing Inspector (FDA Investigator) to...

New FDA Guidance on the Finalization of several FDA Draft Guidances

17/10/2013 21:49
On 7. August 2013 the US FDA published a notice in the federal register entitled "Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances". The FDA is planning to finalize a number of Guidances and is also planning to withdraw several other guidances. These...

Frequently asked GMP Question: How to reduce testing and comply with GMP?

17/10/2013 21:47
Testing active pharmaceutical ingredients, excipients and packaging materials is one of the main tasks of the quality control units in the pharmaceutical industry. It must be ensured that the necessary tests are conducted on the incoming goods and that the materials are released only after their...

EFPIA - What Medicinal Product Manufacturers need to know about the European Verification System EMVS

17/10/2013 21:45
    In a publication from March 2013, the EFPIA shows in a "Guidance for Manufacturers" what requirements a pharmaceutical company has to fulfil that it can be connected with the "European Medicines Verification System" (EMVS) - and thus also can comply...

WHO revises GMP Guide regarding the Principles of GMP

17/10/2013 21:43
  The origins of the WHO GMP Guide go back to 1967. The Guide, which has undergone many revisions and changes since then, was last published as Annex 3 of the Technical Report Document TRS 961 in 2011. The document is so to speak the mother of all GMP...

Article: Are Funny People More Successful in Business? - Forbes article

17/10/2013 04:29
Are Funny People More Successful in Business? - Forbes article which can be applied to your career and to adding humor to your training sessions

FDA is proposing a regulation to implement administrative detention authority during inspections

17/10/2013 00:58
The U.S. Food and Drug Administration (FDA) is proposing a regulation to implement administrative detention authority during inspections. Once the applicable regulation is finalized, it will allow FDA to administratively detain drugs, if an investigator during an inspection has reason to believe...
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