Data Integrity in Pharmaceutical industry - Basics
Categories:
cGMP
Monday, December 19, 2016
Saturday, September 26, 2015
MISBRANDED DRUGs
In recent days, we
are more frequently hearing about the misbranding
of drugs. In many of the USFDA warning letters this word was mentioned.
Misbranding occurs when a product's label is incomplete, false, or
misleading. A product's label includes any written, printed, or graphic
matter that appears on the product or its container. It also includes
information that accompanies the product, such as advertisements for the
product. However, not everything that mentions the product constitutes
labeling. Information that is considered a part of .............................
Click the below link for more details :
Categories:
cGMP
Monday, September 21, 2015
Importance of QC lab
Categories:
cGMP
Data Integrity - An overview
Data integrity is now a hot topic in the pharmaceutical industry due to recent FDA inspections all over the world. FDA is focussing on the integrity of the data generated during the manufacturing process, especially in laboratories, in view of protecting public health. Here is an overview.
Click the below link and the content.
https://sites.google.com/site/pharmaqclabs/data-integrity
Categories:
cGMP
Saturday, September 19, 2015
The cost of poor quality - Quality Behaviour
Very nicely depicted about the quality behaviour
Categories:
cGMP
COMPLIANCE BY DESIGN FOR PHARMACEUTICAL QUALITY CONTROL LABORATORIES - INSIGHT FROM FDA WARNING LETTERS
AUTHOR
Dr. Ludwig Huber Chief Advisor for Global FDA Compliance, Labcompliance ludwig_huber@labcompliance.com
Dr. Ludwig Huber is the editor of www.labcompliance.com, the global online resource for validation and compliance. He is the author of the books “Validation and Qualification in Analytical Laboratories” and “Validation of Computerized Analytical and Networked Systems”. He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China CFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies. For more information, please visit Dr. Huber’s website www.ludwig-huber.com.
Introduction
The mission of the United States Food and Drug Administration (FDA) and equivalent international agencies is to protect consumer health and safety under the Federal Food, Drug, and Cosmetic Act or equivalent international laws. The agencies have developed two basic strategies towards this mission:
• Monitoring the quality of products through surveillance activities such as sampling and analyzing products in distribution.
• Evaluating through factory inspections the conditions under which products are developed, manufactured, tested, packed, labeled, and held.
Read the article :
https://sites.google.com/site/pharmaqclabs/articles
Dr. Ludwig Huber Chief Advisor for Global FDA Compliance, Labcompliance ludwig_huber@labcompliance.com
Dr. Ludwig Huber is the editor of www.labcompliance.com, the global online resource for validation and compliance. He is the author of the books “Validation and Qualification in Analytical Laboratories” and “Validation of Computerized Analytical and Networked Systems”. He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China CFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies. For more information, please visit Dr. Huber’s website www.ludwig-huber.com.
Introduction
The mission of the United States Food and Drug Administration (FDA) and equivalent international agencies is to protect consumer health and safety under the Federal Food, Drug, and Cosmetic Act or equivalent international laws. The agencies have developed two basic strategies towards this mission:
• Monitoring the quality of products through surveillance activities such as sampling and analyzing products in distribution.
• Evaluating through factory inspections the conditions under which products are developed, manufactured, tested, packed, labeled, and held.
Read the article :
https://sites.google.com/site/pharmaqclabs/articles
Categories:
cGMP
Thursday, September 17, 2015
Pharmaceutical Quality Community - Serving patients across the globe
People who are working in pharmaceutical sector mainly in Quality Units are rendering their services to the society in a dedicated way. These people are serving the patients indirectly and very key persons in protecting the public health. Quality is a very critical parameter in drug manufacturing and in reducing the risk for patients.
Quality control and quality assurance groups must have positive attitude and sincerity in their job responsibilities. Dedication and continuous alert on the activities which they are performing daily are the key elements in achieving the quality medicines.
Pls click the following link to access and download the magazine.
Quality control and quality assurance groups must have positive attitude and sincerity in their job responsibilities. Dedication and continuous alert on the activities which they are performing daily are the key elements in achieving the quality medicines.
Hence, as an effort of motivation sharing my leanings and thoughts with the Quality community in the form of my personal magazine ANALIGHT. This is my personal knowledge sharing magazine. It gives immense
pleasure to share what I learnt and the content I collected during my learning.
I believe knowledge increases in multiple folds when we shared it with as many
people as possible. I named my magazine as "ANALIGHT"and publishing
the first copy today which is very auspicious day "Ganesh Chaturthi".
May the lord of Knowledge, the Ganesha, bless us always.
Pls click the following link to access and download the magazine.
Categories:
cGMP
