Inspiring Life of Thomas Alva Edison

A great scientist with hundreds of new inventions. Everybody must read his life because many of his inventions are part of our life.

Pls click the link :  https://sites.google.com/site/pharmaqclabs/inspiring-life-of-thomas-alva-Edison

Successful Microbiological Investigations

Sharing an interesting article which was printed in the March 2011 issue of American Pharmaceutical Review - Volume 14, Issue 2. This will give some idea on microbiological investigations. 

Author Biography

Dr. Scott Sutton earned his B.S. in Genetics from the University of California at Davis, and his Masters and Ph.D. in Microbiology from the University of Rochester (Rochester, NY). After an NIH postdoctoral fellowship at the Medical College of Virginia (Richmond, VA), he went to work for Bausch and Lomb (Rochester, NY) until 1994 when he accepted a position at Alcon Laboratories (Fort Worth, TX). Dr. Sutton left Alcon Laboratories in 2004 as a Director in the R&D division to accept a position as Pharma Consultant (Microbiology) with Vectech Pharmaceutical Consultants, Inc which he left in 2009 as Sr. Director, Microbiology Services.

Scott Sutton is the Principal of Microbiology Network, Inc, a company he started in 1996 as a means to encourage training and communications within the microbiological community. He is a recognized consultant and trainer with emphasis in GMP, investigations, Environmental Monitoring and contamination control (both Aseptic manufacturing and non-sterile production facilities) and microbiology laboratory audits and operations. The Microbiology Network supplies consulting, training, webinars and Email discussion groups (PMFList, PSDGList and C-CEList) Dr. Sutton is an active author and speaker for the industry, supports PDA and has served with the USP Analytical Microbiology Committee of Experts since 1993.

Pls click the below Link to read the article :
                  https://sites.google.com/site/pharmaqclabs/successful-microbiological-investigations 

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 : 

              https://sites.google.com/site/pharmaqclabs/misbranded-drugs

Decide to work safely or not safely

Safe use of lab chemicals

The laboratory environment can be a hazardous place to work. Laboratory workers are exposed to numerous potential hazards. Know the essential procedures that are required to safeguard yourself from hazards. 

Pls click the below link to read the details

https://sites.google.com/site/pharmaqclabs/safe-use-of-chemicals

Basic Chemistry Lab Equipment

Laboratory Glassware

Glassware has an important role in the lab testing. Dirty glassware can lead to an erroneous results. Proper handling and care of glassware is essential. Pls click the link to learn some more details.


https://sites.google.com/site/pharmaqclabs/laboratory-glassware

Weighing on an Analytical Balance, A Chemistry Lab Demo

Calibration of an Analytical Balance

How to operate an electronic balance?

Operation of Electronic balance

Micro, semi micro and analytical balances are measuring  instruments  of the highest precision. The following points will help us obtain reliable weighing results rapidly.

a. Leveling

    Check the air bubble is in the center of the level and if necessary correct this by turning the     leveling feet. Then calibrate the balance.

 

b. Turn the balance on by pressing the control bar. The display lights up for several seconds,       then resets to 0.0000. Then calibrate the balance.

    

c. Place creased, small weighing paper on the balance pan.

    

d. Close the sliding glass doors. Wait for the green dot on the left to go out. This is the        

    stability indicator light, indicating that the weight is stable.

  

e. Press the control bar to cancel out the weight of the container or paper. The display will 

    again read 0.0000.

f. Clean-up

      Use the brush provided to clean spills in the weighing chamber. Discard any disposable tare     

      containers, weighing paper, or Kimwipes in the nearest wastebasket.

Precautions 

1. Don't pick up tare containers with bare hands since your fingerprints add mass. Use Kimwipes or tongs to prevent this.
2. Don't lean on the bench while weighing.
3. Do record the mass of your container, if you will need it later.
4. Do check the level indicator bubble before weighing. The two rear balance feet serve as leveling screws.
5. Do not bump or place objects on the bench after zeroing the balance.
6. Mass powders on paper or dishes. Handle objects with tongs, tweezers, gloves, or paper to prevent fingerprints.
7. Let hot objects cool before massing.
8. Mass hygroscopic materials rapidly since they will absorb water during massing.
9. When making repetitive massing always use the same procedure.
10. DO NOT go off and leave spilled chemicals on or around the balance! Report any spill to the instructor so that he/she may clean it up in a proper manner, re-calibrating if necessary.

EFFECT OF MOISTURE ON DRUGS

Here are some notes I have taken during my reading of various articles.
I hope this will help you. Click the following link to get the file attachment.

https://sites.google.com/site/pharmaqclabs/effect-of-moisture-on-drugs

Importance of QC lab

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

The cost of poor quality - Quality Behaviour

Very nicely depicted about the quality behaviour

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

FDA Shows Flexibility in Rare Disease Drug Development

Companies developing drugs for rare diseases that lack alternative treatments may be able to start clinical trials without the standard toxicology studies, provided they justify the approach, the FDA says.

The agency urges sponsors to meet with it early in the drug development process — before animal studies are begun — to see if such flexibility is appropriate.
The advice, outlined in guidance released Aug. 14, acknowledges the fact that patients with rare diseases may be willing to take greater risks than those with common, often less serious diseases.

The FDA also advises pre-IND meetings to discuss the availability of appropriate endpoints.
Well-characterized efficacy endpoints may not always be available for rare diseases, the agency points out. In such cases, drugmakers should develop new patient assessment tools, taking into consideration their validity, reliability, feasibility, resistance to bias, ability to detect change and clinical interpretability.

The FDA notes, for instance, that a Phase 3 study with a primary efficacy endpoint that is clinically meaningful but prone to bias may benefit from having secondary endpoints, such as laboratory measurements, that are bias-resistant. In early-stage trials, the ability to detect change may be more important than clinical meaningfulness to establish proof of concept.
Sponsors should also take advantage of pre-IND and other meetings to discuss their knowledge of the disease pathophysiology and the proposed drug’s mechanism for treatment, the agency says.

Lack of detail about a rare disease’s pathophysiology can be overcome by examining its natural history before setting out to develop a drug. This will help the company define the disease population, design and implement clinical studies and develop outcome measures and biomarkers.

Design features for a rare disease clinical trial are the same as for other drug trials: a clear statement of objectives, a design that permits valid comparison with a control, appropriate patient selection, methods to minimize bias and assess patients’ response and ability to analyze effects of treatment. With rare disease trials, however, the minimum number of patients required to establish safety and efficacy will be considered case by case, the FDA says.

Comments on the guidance are due Oct. 16.

Source :http://www.fdanews.com/CTA091715?hittrk=CTA1591

The principle of ICP-MS

 

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.

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.

https://sites.google.com/site/pharmaqclabs/magazine-corner