The Indian Pharmacopoeia - 2007

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 of chemicals and dosage forms, it has monographs on vaccines, immunosera, herbs, herbal products, blood and blood-related products, biotechnology and veterinary products.
In the fifth version Categories of a drug, dosage & usual available strength of dosage forms have been omitted. Classical chemical tests for identification of an article have been almost eliminated & more specific IR & UV spectrophotometric tests have been introduced.
There is more emphasis on Use of Chromatographic methods which has been greatly extended to cope with the need for more specificity in assays and test for pyrogens were virtually eliminated. The BET (bacterial endotoxin test) are going to be applicable to more items.

The 21st Century QA, Part-I

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, at least now in the most reputed company, I congratulated him and wish him a great success in his career move.I recalled this call came to me last February, only when he again called me yesterday to reveal his plans for a next change! Totally aghast from my friends routine announcements of changing the jobs despite of working in good organizations, with good pay-package and at senior levels what made the young guys in keep on changing the jobs quite often.This may be a syndrome or symptoms of growing economy and industry needs, but the way quality professionals are changing their jobs put me in introspection. The reason for this sudden change, which my friend shared with me was that “it was again the same routine job”. He explained – “Though, I joined as Senior Manager, Quality Compliance, I was not given a single person in my group,” he complained. That's the routine affair, I tried to console him.Giving it a serious though - Is really Quality Management loosing its glitter which it received in the mid nineties ? Companies are not interested in fully implementing quality systems or is it becoming increasingly difficult to carry on the agenda of quality?
After carefully reviewing the concept paper released by FDA and ICH on 21st century GMPs or the quality systems it clearly reflects the view points of these agencies for future quality systems management, particularly in pharmaceutical industry. These guidance's describes the comprehensive quality systems model, which, if implemented, will allow manufacturers to operate robust, modern quality systems that are fully compliant with cGMP regulations. The overarching philosophy philosophy articulated in these guidelines is Quality should be built into the product, and testing alone cannot be relied on to ensure product quality. This statement in fact lay down the future prespective of quality systems in the pharmaceutical industry.
Therefore, it is now the onus of quality professionals to realise the visionary statement which emphasizes on building quality into the products rather then working for quality.The rapid growth of pharma industry into the international markets is phenomenal and the participation of this industry into generic business is even more significant.
It is my belief, that with a pace the pharma industry is moving and expanding, many a times it also becomes difficult to manage the entire operations keeping the options open. India had not seen such economic expansion of industry, markets and business till last decade. It's a high time, great time and also time for introspection! We need to think of innovative ideas which are indigenous and compatible to our needs and fulfil the concept of quality by design. Now, it is a collective responsibility of companies and the stalwarts of industry to re-design the Quality Systems and their approach towards quality. We have moved ahead from the earlier stages of maturity. The concepts are not new to the industry and above all their is an immense wealth of experience in managing technology, operations, management and systems.My firend may have other different reasons also to make quick changes in job, but, the after effects of our dialogue and then followed by introspection opened new gateway of ideas giving birth to -quality process re-engineering.In my subsequent writings, I will be giving more information on the GMPs, which is much easier to practice, implement and above all productive !!

GAMP 5 on Desks -

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 toward the use of products and packaged solutions and away from bespoke developments.
As a result the GAMP Council is planning to revise the GAMP Guide to reflect current regulatory expectations and current industry good practice while maintaining continuity with GAMP 4 principles. The Guide will be focus on the use of products and packaged solutions rather than custom (bespoke) systems.
The emphasis will be on providing a cost effective approach to validation that will demonstrate that a computerized system is fit for its intended use, while avoiding unnecessary work. To support this, new and updated guidance is in development on the following aspects:

• Scaleable validation approach driven by risk to product quality, patient safety and regulatory compliance including supporting records.
• Integration of validation activities within a complete life cycle approach as part of a Quality Management System (QMS), from concept through development and operation to retirement.
• Use of supplier documentation and knowledge wherever possible to avoid repetition and duplication.
• Importance of clear requirements based on a thorough understanding of the process and product.
• Improving validation efficiency by enabling practical and efficient interpretation of GAMP guidance

Concepts and terminology will be aligned with recent regulatory developments including:

• FDA cGMPs for the 21st Century Initiative and associated guidance.
• PIC/S Guidance.
• ICH (International Council for Harmonization) Guidance Q9 and Q10.
• Emerging standards such as those produced by the ASTM E55 Committee

Source : ISPE, GAMP COP.

USP on Net !

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 and get the details quickly. This is information and knowledge right at your desktop. To maintain copyright, the creators have although, disabled the provision to copy the text.

Click here to browse USP 29

Judgement of Lupin versus King Pharmaceuticals

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:

Proposed Revision in 21 CFR Part 211

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 from April 17, 2008, if no significant comments are received before February 19, 2008.

Based on the CGMP Working Group’s analysis, FDA decided to take an incremental approach to modifying parts 210 and 211. This is the first increment of modifications to parts 210 and 211

The major highlights for this revision being the following:

A. Plumbing
B. Aseptic Processing
C. Asbestos Filters
D. Verification by second individual

For details summary, read here:

Summary for Annexure to ICH Q8, Product Development

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 further clarifications of key concepts outlines in the core guidelines. Additionally, the annexure also explains the principles of quality by design (QbD). In other words, there are two fundamental concepts which emerge from Q8 as whole – (a) integrated pharmaceutical development and (b) submission of related information’s in common technical document format.

For complete summary of the Annexure to Q8, Read here:

Training for Trainers - AIMA workshop at Mumbai

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 organising of training programs.

The program addresses the following:

1. Five principles of adults learning;
2. Training objectives,
3. Training Needs Identification / Assessment;
4. Techniques for presentation and presentations skills;
5. Learning Strategies;
6. Training Models;
7. Training Evaluations.
8. The program was a good learning experience.

Besides, fun and learning, the program also provided a good networking opportunity. The participants, which were HR or Training professionals shared there experiences on handling different types of trainings, viz. behavioural trainings, technical conclaves and motivation trainings.

In all the overall experience was good and full of learning.