ECA – All About Drugs

All About Drugs

Tout sur les médicaments הכל על תרופות كل شيئ عن الأدوية Все о наркотиках 关于药品的一切 డ్రగ్స్ గురించి అన్ని 마약에 관한 모든 것 Όλα για τα Ναρκωτικά Complete Tracking of Drugs Across the World by Dr Anthony Melvin Crasto, Worldpeacepeaker, worlddrugtracker, PH.D (ICT), MUMBAI, INDIA, Worlddrugtracker, Helping millions, 9 million hits on google on all websites, 2.5 lakh connections on all networks, “ALL FOR DRUGS” CATERS TO EDUCATION GLOBALLY, No commercial exploits are done or advertisements added by me. This is a compilation for educational purposes only. P.S. : The views expressed are my personal and in no-way suggest the views of the professional body or the company that I represent

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The ECA’s Visual Inspection Group has developed a new document with answers to frequently asked questions. This new Q&A document is now available for download on the Group’s website. Read more about frequently asked questions in the visual inspection.

http://www.gmp-compliance.org/enews_05500_New-Q-A-Document-on-the-Visual-Inspection-of-Parenterals-available_15266,15265,15221,15662,Z-PEM_n.html

The Visual Inspection Group, an Interest Group of the ECA Foundation, has developed a new document with frequently asked questions. The new Q&A document, which was compiled by the Group’s Board, is now available for a free of charge download on the website.

For compiling the document the members of the Group were asked to provide their questions in February. These questions were then evaluated and answered by the Board Members.

The new document is structured as follows:

Manual Inspection
Automated Inspection
Qualification / Validation
Test sets
Re-Qualification
AQL-Tests
Defect Categorisation
Specific Products
Regulatory Affairs
Process Control / SPC

Some examples for the questions and the respective answers:

The grey portion of fully automatic control is often checked manually, to return not clearly or fully tested products back to the inspection process. Is it allowed to carry out this testing with the automated inspection machine?

From a GMP view, there are no restrictions. It is also important here that at the end a yield calculation and evaluation in the batch record appears. And there are also automated inspection systems that have already integrated the double inspection with multiple cameras.

In highly automated manufacturing lines for LVP flexible containers, the visual inspection process may/cannot comply to the standard visual inspection criteria e.g.: 5 sec inspection time, agitation of the container etc. Is this a compliance problem?

The requirements like 5 sec inspection time required by pharmacopoeias are addressing manually performed visual inspection. If the visual inspection is performed automatically, it is the company’s responsibility to ensure that the inspection via camera systems is as effective as a manual visual inspection via a validation (e.g. Knapp Test).

Should the AQL be inspected by QC or production

AQL manual inspection may be carried out by production staff (to avoid setting up a separate visual inspection team in QC) under a quality oversight or the quality unit. If performed by production operators, the AQL test should not be done by members of the team that was performing the 100 % visual inspection of the batch.

The new Q&A document is available for members in the members’ area on the Visual Inspection Group website free of charge. Membership in the Group is also free of charge and merely requires a registration.

The Good Practice Guide “Visual Inspection of medicinal products for parenteral use”, was also revised. The new Version 3.0 will be introduced at the ECA Conference Particles in Parenterals in Barcelona, Spain, from 28-29 September 2016. All delegates of the conference will receive a free copy.

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How to access ten thousand pages of GMP Guidelines from FDA, EMA, ICH, PIC/S, ICH, WHO and many other organisations worldwide? You can print them or purchase hundreds of booklets. Or, alternatively, you can take advantage of a software tool developed by the ECA Academy, allowing you to access to the most comprehensive GMP Guideline Database

http://www.gmp-compliance.org/eca_mitt_05241_n.html

How to access ten thousand pages of GMP Guidelines from FDA, EMA, ICH, PIC/S, ICH, WHO and many other organisations worldwide? You can print them or purchase hundereds of booklets. But this will cause a huge amount of paper. And it will be more than difficult to find a specific regulatory requirement in this comprehensive library.

For that reason the ECA Academy has started to set up the largest GMP Guideline Database of its kind worldwide already 18 years ago. And every year a new release is published with all updates. A software was developed to structure the Guidelines in two so called “Guideline Trees”.

1. Guideline Tree structured according to the issuing authorities (e.g. EU, FDA, ICH)

2. Guideline Tree structured according to GMP topics (e.g. GMP for Medicinal Products, GMP for APIs, sterile production, validation etc)

In addition to the two structured libraries the software also allows you to search for certain key words. You may search the entire database for a keyword like “validation”. But you can also limit the search to certain areas (e.g. search in FDA Guidelines only).

If you have no CD drive on your computer you can also access the GMP Guideline Manager via the ECA WebApp. When you register you will receive the login details to access the ECA members area. The same login details will work for the ECA WebApp. With this service you can access the full GMP Guideline Database from your smartphone or tablet via the internet.

The GMP Guideline Manager can not be purchased – it is only available for ECA Members at no costs! This service is unique and not offered by any other organisation. By participating in any of the ECA conferences or courses you become member of the ECA free of charge for 2 years. If you can not attend an ECA course you can also apply for ECA membership for only 190,- Euro via our webpage.

Please find more information about the GMP Guideline Manager 18.0 here.

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