RSS Newsfeed  Your shopping cart.
ECA Academy - Your GMP/GDP Information Source
SEARCH

Search in

Keyword

GMP Publications

 

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
NEW: Annex 16 (in operation since 15 April 2016)
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.
  • 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 - "GMP Matrix" (Version 19 of March 2016)

"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: Revised GMP/DIN ISO 9001 Matrix-  based upon the new DIN EN ISO 9001-2015 | Revised ICH Q10 / ISO 9001:2015 Matrix | New Annex 16, coming into operation on 15 April 2016 | New DIN EN ISO 9001:2015

  • FDA cGMP Guide
  • EU GMP Guide Part I, II, and III incl. all Annexes
  • ISO 9001 Quality Management Systems

In total, the Guide has 570 pages.

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 APIs & How to do Guide
with a Side-by-Side comparison and APIC's How-to-do Document
(Version 8, update of August 2015)
  • 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!

  Guidelines of 5 November 2013 on Good Distribution Practice (GDP) of medicinal products for human use (Text with EEA relevance)
(2013/C 343/01)
Paperback in the handy format 11,5 x 15 cm
- 95 pages
- Original English version plus the official German translation

Price*: € 25 Non ECA Members, € 15 ECA Members
  Copies

When purchasing 10 to 50 copies € 22 per copy
When purchasing > 50 copies € 18 per copy

Booksellers receive a 15% discount - please ask for a COUPON CODE before ordering!

  FDA Medical Device Warning Letter Navigator on CD ROM
A compilation of:
  • Warning Letters regarding medical devices from 2002 to 2014
  • FDA regulations for Medical Devices
  • GHTF documents for Medical Devices
  • EU regulations for Medical Devices

Price*: € 99 Non ECA Members, € 69 ECA Members

  Copies

Booksellers receive a 15% discount - please ask for a COUPON CODE before ordering!

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.

Please click here to read the Table of Contents.

Price*: € 64

Copies

 
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.

Please click here to read the Table of Contents.
Please click here to read an Extract.
 

Price*: € 64

Copies

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

Please click here to read the Table of Contents.
Please click here to read an Extract.

Price*: € 64

Copies

 

*All prices plus postage, packing, and VAT (if applicable)

     
 GMP Conferences by Topics
 Quality Assurance
 GMP in Biotechnology
 Microbiology
 Regulatory Affairs
 GMP in Pharmaceutical Development
 Quality Control
 Storage, Distribution, Transportation
 Sterile / Aseptic Manufacturing
 Computer Validation
 Technical Operations
 GMP for APIs and Excipients
 Validation
 Medical Devices
 GMP Basic Training Courses
 Packaging