Commission Delegated Act on Principles and Guidelines on good

From:
)@aefi.org>
HI
Ares(20i 5)5462899 •• 30/11/201
Sent:
24 November 2015 15:18
To:
SANTE-D6-DA-GM P-l M P
Subject:
CONSULTATION ON Commission Delegated Act on Principles and Guidelines on GMP for investigational medicinal
products {AEFI)
Dear Sirs,
The Spanish Association of Pharmacists in Industry (AEFI), as a representative organism of pharmacists and other professionals that
serve in Industry, would like to send you the following comment on the Consultation Document,
Commission Delegated Act on Principles and Guidelines on good manufacturing practice for investigational medicinal
products for human use and inspection procedures, pursuant to the first subparagraph of Article 63 (1) of Regulation (EU)
N 536/2014
Question la: Would a requirement for a product specification file (a reference file containing, or referring to files containing, all the information necessary
to draft the detailed written instructions on processing, packaging, quality control testing, batch release and shipping of an investigational medicinal
product) be useful to be introduced? It would be very useful.
Yours faithfully,
blog AEFI: www.aefi.org.es
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