tag:blogger.com,1999:blog-75753343388644892502012-01-27T12:07:01.165+05:30Viewpoint on - GMPs, - Pharmaceutical Manufacturing Systems Management, -Regulatory Compliance and related Corporate Strategies.Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.comBlogger531100tag:blogger.com,1999:blog-7575334338864489250.post-85036783692916205162012-01-27T12:05:00.001+05:302012-01-27T12:07:01.175+05:30

In continuation to my earlier post related to AIP featuring Ranbaxy's and FDA saga, the 'consent decree' might be the forward looking statement to both the parties. While FDA moves ahead with caution and pre-fixed direction, Ranbaxy makes firm committment towards its Quality Assurance program and prmomise to provide safe and quality medicines. Consent decree is an order issued by a judge that

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-9108573398914806852011-10-31T22:10:00.003+05:302011-11-10T13:42:46.126+05:30

The Excipients finally have come inside the auditing ring. The much awaited standards for auditing Excipients is going to release. The standards, known as Excipact some time in January 2012. IPEC, the excipients association says that this standard will give suppliers, users and auditors manufacturing and distribution standards that ensure product quality and minimize regulatory burden. The

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-66138916610782985202011-09-08T16:15:00.002+05:302011-09-08T16:17:51.186+05:30

It was just last month while dispensing a tablet for my wife, which was on a higher dosage, I need to adjust the dosage but realized it was rather difficult to break or split it in two pieces to get it of lower dosage as prescribed by the physician. The difficulty in breaking it was due to the fact, the tablet was not scored. As it was also film coated, the split or broken piece was to be

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-46495942127897391022011-08-30T10:56:00.001+05:302011-08-30T10:57:24.339+05:30

In Part III of the EU GMP Guide, a document on internationally harmonised requirements for batch certification has been added. It is applicable in the context of Mutual Recognition Agreements (MRA), Agreements on Conformity Assessment and Acceptance of Industrial Products (ACAA) and other appropriate arrangements on GMP with the European Union. Each batch of medicinal product transferred between

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-46732378647281423242011-08-30T10:46:00.000+05:302011-08-30T10:46:08.909+05:30

Its been a long time in my endeavour to blogging or more precisely writing my thoughts. Not because, I was too occupied, or lack ideas, but somehow I was lagging the enthusiasm for writing. Anyhow, better later than never and so I am back again. In one of my earlier post, I mentioned about quality as an idea. This is just an extension of my earlier though emphasising on thought and idea and

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-22500976987037885752011-06-01T22:06:00.003+05:302011-06-02T09:36:29.789+05:30

Are continuous audits really helpful in improvement? Does audits really increase the band width of quality systems or it has taken the shape of mere formality? and the things continue the way they are? The importance to the business in identifying risks within a department’s operating procedures has become more and more pronounced but many auditors complain that they operate with one hand

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-10553833071598767462011-01-09T11:37:00.002+05:302011-01-09T11:41:31.645+05:30

From an old post in Plaxo; Ideas never die. Ideas live forever. Once the germ of an idea is born..it remains. So is quality also an idea ? Is quality a thought ? or attitude ? or pursuit for excellence ? whatever it is, but why it is what it is. The philosophical debate on quality will continue. It will give many answers which may or may not fit best to the question that what quality is! I

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-8568818727441901232010-09-29T08:37:00.000+05:302010-09-29T08:37:48.789+05:30

BPTF or Bulk Pharmaceutical Task Force, a SOCMA organization has launched a template for preparing quality agreement to provide guidance for drafting agreements related to the manufacture and release of drug substances regulated by various regulatory agencies. The template is based on the experience of industry members. For more information and downloading of the template, click here

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-71405745471033814592010-09-16T09:47:00.001+05:302010-09-16T09:52:36.049+05:30

Thanks to Mr Shirgaonkar for this wonderful information ! Knowledge of Good Laboratory Practices is very important in Pharmaceutical industry. New GLP requirements as per Schedule L1 of Drug Rules will come into effect from 1st November 2010. Topics such as General laboratory requirements,instruments calibration, microbiological testing and internal audit will be covered in this statutory

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-40459069255440732612010-09-03T22:44:00.000+05:302010-09-03T22:44:35.556+05:30

Keyoor has forwarded an interesting information. The jumping of chemicals from one list to another will continue. The information says that ICH is revising the status of Isopropylbenzene to Class 2 from existing Class 3 ! This is somewhat a demotion of Isopropylbenzene which was previously in the safer Class 3. It also means that there will be an upper specification limit to Isopropylbenzene and

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-15801649703279005512010-08-28T09:36:00.002+05:302010-08-28T10:22:40.458+05:30

CDSCO website in new avatar. Since my last visit to the website, may be at a gap of a year, I realise, CDSCO has included various multidisciplinary topics. Navigation is made easy and search relatively better. The best part is the inclusion of "Guidance to Industry" documents in the line of US FDA. The recent addition to this is a draft guidance for fixed dose combination. There are separate

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-33793551329058249732010-07-18T20:37:00.000+05:302010-07-18T20:37:45.337+05:30

AIP is Application Integrity Policy. The policy focuses on the integrity of data and information in applications submitted for Agency (FDA) review and approval. The AIP described Agency's approach regarding the review of applications that may be affected by wrongful acts that raise significant questions regarding data reliability. Although the guidance document does not create or confer any

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-87212832546866222472010-05-10T20:30:00.001+05:302010-07-17T20:26:48.661+05:30

At the end of February 2010, the European Medicines Agency (EMA) published a draft paper revising their process validation guidelines Elements from the guidelines ICH Q8 (Pharmaceutical Development), ICH Q9 (Quality Risk Management) and ICH Q10 (Pharmaceutical Quality Systems) are to flow in, particularly in the process areas of Analytical Technology (PAT), Quality by Design (QbD) and Real Time

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-26348666866377223982010-04-17T13:22:00.001+05:302010-04-17T13:22:05.440+05:30

An amendment is made to Part II of the GMP Guide to incorporate principles of Quality Risk Management in line with the ICH Q9 guideline on Quality Risk Management. Amendments correspond to similar changes made to Part I Chapter 1 of the Guide and published in February 2008. A new section on Quality Risk Management is introduced as section 2.19. The remaining sections of chapter 2 are renumbered.

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-38085388138121971902009-10-18T11:36:00.000+05:302009-10-18T11:36:45.880+05:30

Concerns to GMPs are generally linked to the fear of FDA Auditors. As if the systems and procedures of organization are designed for the inspectors rather then for the internal improvements.  First, there is no separate point of view of FDA from cGMP / system requirements. A self justified system with appropriate scientific rational must be acceptable to anyone, including FDA inspectors.  The

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-2478372009674796562009-10-06T21:11:00.002+05:302009-10-06T21:13:42.706+05:30

It's good to see you all here following 'Realm of Quality'. Indeed it gives immense pleasure to see the numbers growing - not just for the sake of numbers, but to see you all who are interested to know more on practical GMPs and basic Industrial Quality Management per se. Currently working on Environment Monitoring for non-sterile Manufacturing. It is taking bit time, but shall come back soon on

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-45716892733079642372009-08-30T14:35:00.002+05:302009-08-30T18:17:36.282+05:30

While there is a conductivity meter already installed at the purified water generation system, the absence of on-line conductivity meter prior to the entry point of return loop (to purified water storage tank ) is somewhat not acceptable.No matter how technically good the purified water generation system is designed with SS 316 water distribution loop with electro polished pipelines (>20 mm

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-82749162437139102652009-07-02T22:02:00.005+05:302009-07-02T23:16:19.634+05:30

What is the difference between a ‘change room’ and an ‘air-lock’? When Michael requested for more clarification on change rooms design vis-à-vis pressure differentials and movement of air, I didn’t thought that our discussion will go in so detail. While a change room is generally required for change of outside attire before entering a clean zone, the applied air-pressure differentials makes it an

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com3tag:blogger.com,1999:blog-7575334338864489250.post-42642468662959902912009-05-19T20:23:00.002+05:302009-05-19T20:29:58.356+05:30

FDA website is in a new avtaar. The new design of FDA website is dazzaling, easy in navigation and user friendly. Visitors to the new, improved Food and Drug Administration (FDA) Web site will find critical recall and consumer safety alerts now located right up front where they belong. Based on months of feedback from its core audience -- consumers, doctors, and the health care industry -- the

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com2tag:blogger.com,1999:blog-7575334338864489250.post-1743459410886189952009-04-09T20:15:00.003+05:302009-07-15T19:47:58.528+05:30

When one of my frined enquired about re-qualifcation requirements of LAF for any reason, it was easy to reply - Hey buddy, go for velocity, linearity, leak test(DOP Test), no. of air changes , temperature and humidity. That's true, these are all the requirements when a LAF needs to be re-qualified, say after re-installation, major maintenance or replacement of major component (e.g. blower).But

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-24578847293594919202009-02-28T23:54:00.006+05:302009-03-01T10:59:53.616+05:30

H B Dandekar refreshes the evolution of GMPs globally and in India in in his article in 'Express Pharma Pulse'. An interesting article to abreast knowledge on GMPs and its journey till today.The excerpts from the article are given below. However for complete article, click hereThe evolution of GMP in pharmaceutical manufacturing may be traced back to the year 1960/61, when entire Europe was

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-80143052182461439962009-02-14T09:43:00.004+05:302009-02-14T09:52:49.843+05:30

The Economic Times reports that domestic drug makers may not require GMP certificate from WHO. As popularly known within Pharma fraternity, the COPP (Certificate of Pharmaceutical Products) is issued by DCGI on behalf of WHO after a GMP inspection of a firm which intends to export its products. This could be a way forward by DCGI and CDSCO which intents to bring Indian GMPs or Schedule M at par

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com1tag:blogger.com,1999:blog-7575334338864489250.post-10295877191809874572009-01-15T19:27:00.005+05:302009-01-23T23:27:30.107+05:30

It was a usual discussion on the definition of 'Quality'. In fact for every Quality personnel or for those who steps in the domain of Quality, the definition of quality is the most intrigued one. During the days of my training in the Quality Assurance, the first chapter or rather the first thing I was introduced to was the definition of 'Quality'. Masters of Quality have spent their lives in

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-79176153614120826082009-01-14T23:16:00.001+05:302009-01-14T23:17:58.668+05:30

What lies in between Audits and Compliance ? Is it's all same that lies in between the sky and the earth ? Well, I would say No. Audits gives observations or findings which are systemic gaps or differences from the laid down 'Quality' (GMP) Systems. The Compliance of such gaps indicates the intentions of the Management, Staff and other stake holders toward the direction in which Company wants to

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-7537410105994987262008-12-31T15:34:00.002+05:302008-12-31T17:34:43.079+05:30

As we move into the new year I wish all my readers a very Happy and Prosperous New Year. I also thank you all for visiting my blog and giving valuable comments and suggestions throughout this year.When we move into a new year, it seems nothing new is happening. May be this is the sign of my growing age which has seen 35 springs and therefore 'New Year' really do not appear new !!Or may be the

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-43097680864750248352008-12-13T09:45:00.004+05:302008-12-13T23:12:12.026+05:30

Announcement to ammend the Drugs & Cosmetics Act to include Schedule L-I of Rules 74, 78 and 150 E (Third Amendment Rules 2008) giving the pharmaceutical industry time till November 1, 2010 for compliance of Good Laboratory Practices. This comes at least 20 years after the last ammendmend made into the US rules in 1987 as 21 CFR part 58 which came into effect in 1979.Better Late than Never for

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-39540234228827051132008-11-09T14:16:00.006+05:302008-11-09T14:31:11.855+05:30

The changes in the GMP rules by the FDA after due consultation from Industry are finally announced. Effective from 8th September, primarily these changes focus on - Plumbing, Aseptic processing, Asbestos filters and Verification by second individual etc.While a summary of the proposal was already published in details sometimes back in April (click here to read), Krishna Rao has also done a great

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-90674765178855080222008-10-09T21:52:00.003+05:302008-10-10T13:36:00.092+05:30

It seems that the quality related issues from China will never end. In fact even when the storm of Heparin was about to settle down, other serious complaints from Chinese made infants milk and other milk related cases started appearing at the global horizon. As the countries were still in the process of enforcing a ban to import Chinese milk products, another news came that three people died

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-9314274490304331302008-09-15T20:18:00.007+05:302008-10-10T13:43:03.338+05:30

The seminar was inaugurated by the Chief Minister of Andhra Pradesh Dr Y Rajasekhar Reddy by liting lamp along with Dr. K Anji Reddy, Chairman Dr Reddy's Laboratories Limited. Dr. K. Anji Reddy was felicitated by Chief Minister by presenting a shawl as a souvenir.Speakers in the seminar from different disciplines of Drugs & Pharmaceuticals industry shared their experiences, thoughts and

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-4682932995224731082008-07-28T20:32:00.011+05:302008-07-31T07:25:51.202+05:30

When FDA first published its visionary paper on 21st Century Initiatives, it's purpose was to give direction to the innovation in technology and management for fully (current) grown pharmaceutical industry. Besides this, the other initiatives which FDA and other regulatory agencies have taken, namely PAT, risk based approach and defining quality systems in GMP prespective are all moving in the

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-22758763186193587662008-07-21T10:01:00.008+05:302008-10-12T08:01:44.060+05:30

The fear of Audits is still alive! Even after at least 3 decades since the first Pharmaceutical facility was audited in India from US FDA, the nervousness to face a FDA inspection has not ended. Even the big Indian companies with good track record have to prepare for the audit much in advance. The audit exercise can only be compared with a father preparing for the marriage of his only daughter.

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-66801970564115943082008-06-12T18:14:00.003+05:302008-06-18T19:40:31.890+05:30

That was a hectic period. I have taken a break from blogging, but shall comeback soon !!-------------------------------------------------------------------------------------------------Forthcoming - Acquasition of Ranbaxy and future of Regulated Companies in India.

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-32289357811216377822008-04-30T22:34:00.007+05:302008-05-01T05:18:50.880+05:30

Ideas never die. Ideas live forever. Once the germ of an idea is born..it remains. So is quality also an idea ? Is quality a thought ? or attitude ? or pursuit for excellence ? whatever it is, but why it is what it is. The philosophical debate on quality will continue. It will give many answers which may or may not fit best to the question that what quality is!I remember entering the room of a

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-14557688004041427702008-04-05T22:00:00.002+05:302008-04-05T22:03:50.963+05:30

Vishwanath in the Pharmaceutical Discussion Forum, informs the new wonder from USP. The USP has recently launched a Column Equivalency tool on it's web-site - This is an interactive aid that assists user in finding a ‘Possible Alternative Column' to the Column used in development & Validation of a certain Chromatographic Procedure.The USP procedure uses the parity among the parameters like CTF (

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-85146625243852380552008-03-30T19:02:00.004+05:302009-01-23T23:22:37.185+05:30

I have never thought that a simple phrase spoken in a get together by my boss would have such a deep impact in my mind - "Quality is free"! Whenever, the corporates thinks for the implementation of quality initiatives, the only purpose is its strategic importance for encashing its value - in terms of credentials, reputation and also improvement in goods. However, what most corporates worries is

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-20883891690708873182008-03-15T10:55:00.000+05:302008-03-15T10:56:44.986+05:30

In what may be seen as a setback to India and the progress of its pharmaceutical industry as such, the US State department has announced to set up a full time permanent US FDA office in China. The opening of this office is although pending from the approval to be obtained from government of China.In earlier news last year, the FDA was planning to open their office in one of the city in India

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-64899488801583883472008-03-02T22:37:00.004+05:302008-03-02T23:18:18.768+05:30

It was the year 2005 when India adopted patent regeime. The worst fear which was projected was that of loosing India's strength over pharmaceutical development and manufacturing.Much of that fear has already lost withn last 3 years. On the contarary, the MNCs operating in India from at least last 40 to 50 years have eroded their market captelisation.The Pfizer, Novartis and Merck have all lost

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-75621432384588847182008-03-01T12:04:00.004+05:302008-03-01T19:29:47.362+05:30

It was rather 5 years back, when the concpet of integrating all deficiencies capturing tools with a single investigative and managing tool - CAPA came into thought. Though I had conceptuliased this idea, but its writing it down only took this much of time! The idea is that -CAPA can be developed as a single logbook concept, wherein all the deficiencies are listed, investigated and reviewed. This

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com1tag:blogger.com,1999:blog-7575334338864489250.post-68004002373080787862008-02-28T21:50:00.003+05:302008-02-28T21:57:41.159+05:30

In an earlier published news in the blog 'Eye on FDA', it reports that FDA Inspects Wrong Plant in China!! This is only last weeks report. Oops!!! During what is not a good week for the FDA, following an announcement by the FDA of allergic reactions to Baxter's Heparin it is revealed in the news that the FDA inspected the wrong Chinese plant that manufactured an ingredient of Heparin. Though

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-91240406419984133002008-02-23T14:04:00.003+05:302008-02-24T07:53:02.075+05:30

The FDA CBER website has yesterday (22/02/2008) published another guidance for industry titled 'Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products'.This guidance applies only to the replacement of the sterility test with an appropriate container and closure system integrity test in the stability testing program

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-36155813436688559452008-02-10T19:14:00.000+05:302008-02-12T07:05:22.544+05:30

There is really nothing new or anything different if you go through the ICH Q10 carefully!! Yes, it was already there. Reached to level 2 and released on May 2007, the new Guideline ICH Q10 "Pharmaceutical Quality System" defines that a documented Quality System should be established. Such a quality system should consider not only the GMP requirements but also further standards such as the ISO

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-37482964586479990582008-01-24T09:01:00.001+05:302008-03-04T21:41:03.702+05:30

The much awaited Indian Pharmacopoeia is released at Chennai on 21st January. Though first released by Health Minister in December, this release is formal release is for pharmaceutical fraternity. The IPs fifth edition will be effective from April 2008 has indeed came at right time.The new IP is released in three volumes with 300 monographs and many new features. Besides, the 175 new monographs

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com1tag:blogger.com,1999:blog-7575334338864489250.post-54172271241160582432008-01-19T13:58:00.000+05:302008-01-20T22:38:59.152+05:30

Few months back when one of my friend called me and announced his joining one of India’s biggest and reputed pharmaceutical company, I felt surprised on his new move. The news was important as my friend who is MPharma is also having good technical knowledge and experience in the areas of quality assurance and regulatory compliance. Relieved from the news that now my dear friend will get settled,

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-81451060920580921072008-01-17T07:10:00.000+05:302008-01-17T07:14:50.546+05:30

The number of significant initiatives, from both international regulators and industry, have influenced thinking on how validation in the regulated GxP environment might be achieved in the most effective and efficient manner. This has led to focusing validation on those items that affect product quality and public health using a risk- and science-based approach.There has also been a major move

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-35991460335897822662008-01-15T08:07:00.000+05:302008-01-15T15:27:26.178+05:30

A great work indeed. At least I didn't knew, until I surfed and found it ! The USP 29, NF-24 are on the net with all monographs including molecular structures, appendix and general chapters published as it is.Though there are no details given on the website for its creators, but the domain mentioned as '.cn' indicates that the compendium is uploaded from china.You can browse your favourite titles

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com1tag:blogger.com,1999:blog-7575334338864489250.post-90320734644786805072008-01-12T18:59:00.000+05:302008-01-12T21:46:16.212+05:30

Here is the text of judgment delivered by US Court of Appeals on September 2007 for the litigation with King Pharmaceutical Inc. Lupin was able to crack the ramipril patent held by King Pharma.For full story, read here:

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-16492242565571017972008-01-10T23:21:00.000+05:302008-01-10T23:32:03.202+05:30

The Food and Drug Administration (FDA) is amending certain regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. On Dec 4, 2007, the FDA published changes to FDA's drug GMP regulation (Part 211). This is the first step of a phased approach to modernize GMPs. The revised text will be effective

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-82270058195311072122008-01-06T12:03:00.000+05:302008-01-11T23:29:56.419+05:30

ICH has released the draft consensus guidelines - the annex to ICH Q8 on Pharmaceutical Development. The much awaited release is in its step 2 of ICH process and was made public in November 2007. This is the second release within ICH step 2 processes connecting ICH Q8. The Earlier draft version of Q8 published in 2004 got wide spread response in the industry circles.The Annex to Q8 provides

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-72670280023259316702008-01-04T21:49:00.000+05:302008-01-06T20:09:02.673+05:30

It was a good opportunity to attend three days training workshop on 'Training of Trainers' organised by All India Management Association. The workshop was attended by 35 persons from different companies across the country.The Faculty was - Dr. Sunil Abrol who is well known figure in the domain of Management and Organisational behaviour. He explained different elements related to effective

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-79602355257635697182007-12-25T23:22:00.000+05:302007-12-25T23:28:52.889+05:30

Wishing all readers a Merry Christmas!! Let the jingles of festival brings lot of happiness and joys to everyones life!

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-49263801096061006442007-12-25T10:40:00.000+05:302008-01-24T22:01:54.717+05:30

The adoption of E2500 standards by ASTM is a go to "V" model approach of Validations?? The E2500 standards are adopted by ASTM committee E55 in May 2007. The E 2500 standards titled as "A Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipments"As there are aspects of qualification that add value in terms of ensuring

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-83245224904781700772007-12-23T22:51:00.000+05:302007-12-25T23:21:20.868+05:30

Yes that's true. The recently concluded meet of KOEL at Mumbai was a great success. This is a sign of maturity, as this was a well planned, well informed and well attended meet where the members participated from different parts of the country. And also this was the second consecutive KOEL conference ! Moving ahead ! Cheers buddy's - keep it up !Despite of my wholehearted desire to participate

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0tag:blogger.com,1999:blog-7575334338864489250.post-84331629993344151772007-12-22T22:50:00.000+05:302007-12-23T08:27:02.688+05:30

The name is sufficient- the tree of quality. This topic or I would explain here that the purpose of this blog is not to begin any new quality revolution or any thing that sort of ! It is my strong belief that the concepts and techniques of quality management have a natural extension to all facets of organizational management.It was Dr. Juran who was first to incorporate the human aspect of

Dipankar Kaul -http://www.blogger.com/profile/15565214194455896582noreply@blogger.com0