|Price*:||EUR 18,- (Non ECA Members)|
|EUR 12,- (ECA Members)|
|for 10 to 50 copies: EUR 15,- per copy|
|for over 50 copies: EUR 9.90,- per copy|
Part 1 – Medicinal Products
Part 2 – Active Pharmaceutical Ingredients, incl. Annexes 1-19
Part 3 – Explanatory Notes on the preparation of a Site Master File | Quality Risk Management (ICH Q9) | Pharmaceutical Quality System (ICH Q10) | Internationally harmonised requirements for batch certification | Template for the „written confirmation“ for active substances exported to the EU... | Guideline on setting health based exposure limits for use in Risk identification | Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use.
Part 4: Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products of 22 Nov 2017
|Price*:||EUR 35,- (Non ECA Members)|
|EUR 22,- (ECA Members)|
|for 10 to 50 copies: EUR 30,- per copy|
|for over 50 copies: EUR 25,- per copy|
In addition, the Good Practice Guide contains a ISO 9001/ICH10 Matrix.
In total, the Guide has 570 pages.
"FDA cGMP, EU GMP and ISO 9001 Matrix for a pharmaceutical Quality System - A GMP Roadmap"
The 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.
NEW: Detailed Commission guidelines on good manufacturing practice for investigational medicinal products for human use, pursuant to the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014 (Dec 2017)
|Price*:||EUR 149,- (Non ECA Members)|
|EUR 99,- (ECA Members)|
|No further discounts available|
with a Side-by-Side comparison and APIC's How-to-do Document
Version 10, update of March 2018
|Price*:||EUR 49,- (Non ECA Members)|
|EUR 32,- (ECA Members)|
|for 10 to 50 copies: EUR 44,- per copy|
|for over 50 copies: EUR 39,- per copy|
Paperback in the handy format 11,5 x 15 cm
|Price*:||EUR 25,- (Non ECA Members)|
|EUR 15,- (ECA Members)|
|for 10 to 50 copies: EUR 22,- per copy|
|for over 50 copies: EUR 18,- per copy|
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.
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.
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.
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
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