ECA Good Practice Guide on Validation
(1st Edition of October 2012) This document is intended to
provide support to both regulators and industry. On one hand, the guide
contains the main elements of the new approach ("what to do"). On the
other hand, it also serves as a supporting guide for the implementation
("how to do"). The guide contains 163 pages divided in 5 chapters and 4
annexes. The topics covered are among others:
risk based qualification and validation
legacy products
statistics
case study about process validation in biopharmaceutical
manufacturing
case study about continuous process verification
Paperback in the handy format 14,8 x 21 cm
Price*: € 149 Non ECA Members, € 99 ECA Members
Booksellers receive a 15% discount - please ask for a
COUPON CODE before ordering!
Copies
FDA cGMP Guide
Paperback in the handy format 11.5 x 15 cm, 40 pages
21 CFR 210/211 cGMP
Guide in English
Price*: € 18 Non ECA
Members, € 12 ECA Members
Copies
When purchasing 10 to 50 copies € 15 per copy
When purchasing > 50 copies € 9.90 per copy
Booksellers receive a 15% discount - please ask for a
COUPON CODE before ordering!.
EU Guidelines to Good Manufacturing Practice (Part 1 Medicinal
Products, Part 2 Active Pharmaceutical Ingredients, incl. Annexes 1-19,
Part 3
Site Master File, Quality Risk Management, Pharmaceutical Quality
System, Internationally harmonised requirements for batch certification,
Template for the "written confirmation" for active substances exported
the European Union.
Paperback in the handy format 11.5 x 15 cm
GMP Guide in English
Price*: € 35 Non ECA Members,
€ 22 ECA Members
Copies
When purchasing 10 to 50 copies
€ 30 per copy
When purchasing > 50 copies € 25 per copy
Booksellers receive a 15% discount - please ask for a
COUPON CODE before ordering!
ECA Good Practice Guide
"FDA cGMP,
EC GMP and ISO 9001 Matrix for a pharmaceutical Quality System - A GMP
Roadmap". (Version 13 of April 2013)
The revised ECA Good Practice Guide is a comprehensive juxtaposition
containing the requirements laid down in FDA's cGMP Guide, the EU GMP
Guide and ISO 9001. The updated Matrix now has 26 pages as well as further 500 pages
for the following three regulations
FDA cGMP Guide
EU GMP Guide Part I, II, and III incl. all Annexes
ISO 9001 Quality Management Systems
In addition, the Good Practice Guide contains a ISO
9001/ICH10 Matrix and the complete Part
III to the EU GMP Guide.
Price*: € 149 Non ECA Members, € 99 ECA Members
Booksellers receive a 15% discount - please ask for a
COUPON CODE before ordering!
Copies
No further discounts available
ICH Q7 GMP for Active Pharmaceutical Ingredients
with a Side-by-Side comparison and APIC's How-to-do Document (Version 7
of August 2012)
Paperback in the handy format 15 x 11,5 cm
Complete text of ICH Q7 GMP for APIs
and comparison of the interpretation by the Active Pharmaceutical
Ingredients Committee (APIC)
Price*: € 49 Non ECA Members, € 32 ECA Members
Copies
When purchasing 10 to 50 copies € 44 per copy
When purchasing > 50 copies € 39 per copy
Booksellers receive a 15% discount - please ask for a
COUPON CODE before ordering!
FDA Navigator with Warning Letters Report The FDA Navigator comprises a CD-ROM and a handbook
On the CD, you will find the 200 most important GMP regulations,
guidelines and interpretations by FDA, all in all about 5,000 pages
Warning letters on GMP deviations of the last three years
Warning Letters Report with detailed analysis (citations sorted
by CFR paragraph and year / citations of the CFR paragraphs in the
original wording / trend analyses)
inspection checklist based on the cGMP Guide in German and English
(incl. reference to CFR paragraphs)
All documents are arranged in a clear tree structure. Thus you can
find the desired document click by click.
Search function: You can search all documents on the FDA Navigator
CD for keywords, e.g. for "validation", "deviation", "stability". The
search results include guidelines, FDA presentations and warning
letters
Price*: € 399 (Annual update € 199) Non ECA Members
€ 260 (Annual
update € 130) ECA Members
Booksellers receive a 15% discount - please ask for a
COUPON CODE before ordering!
Copies
The "GMP REPORT" is a new publication series. It
is published in English language. The reports support the implementation
of current GMP guidelines in pharmaceutical operations. There are no
fixed publishing intervals or periods; as a rule, two volumes per year
are issued.
Please note: The GMP Report is not an ECA publication. However, ECA
supports this series as we believe that a European publication in the
field of GMP Compliance has been missing for many years. The GMP REPORT is published by
ECV · Editio Cantor Verlag, Aulendorf (Germany). Your purchase order
will be forwarded to and effected by the ECV.
GMP REPORT No. 1
The first "GMP Report" covers "FDA Requirements for cGMP Compliance".
Twelve Authors from the pharmaceutical industry illustrate the efficient
implementation of FDA's cGMP requirements in routine operations.
GMP REPORT No. 2
In the GMP Report No 2 "The Qualified Person", an overview of the applicable European legislation framework and relevant guidelines is given. The legal duties of the QP like batch certification are introduced and discussed. The aspect of the QP’s discretion in certifying a batch in the case of deviations and OOS results, the possibility of delegating tasks, the responsibilities within the quality system and also necessary skills a QP needs for the daily business are reflected in various articles.
Experts from international pharmaceutical companies as well as from the national authorities will share their experience on these issues and will give first-hand information of what is expected from QPs nowadays and in the future.
GMP REPORT No. 3 A working risk evaluation system is a key element of drug safety.
This is valid for industry as well as for licensing and inspecting
authorities.
Risk assessment is a legal obligation. The state of the art is discussed
on international level and is laid down in GMP guidelines which have to
be observed by all involved parties.
In German QA documents for competent authorities these principles were
transferred into SOPs for inspectors.
Pharmacovigilance and pharmaceutical-technical procedures are subject to
a risk assessment system. Indications and drug characteristics have an
influence on potential risks of the particular measures. During the
production process QA systems and periodic quality reviews ensure that
each product and each process is assessed continuously.
Inspectorates are subjected to inspection planning and the conduction of
inspections according to a risk assessment system. Failure evaluation
and corrective actions are risk orientated
19-20 June 2013 