Quality is free -

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 the Cost of Quality - the phrase - 'Quality is free' is tremendous.
But is quality really free ?? If so then what it the Cost of Quality ? 

Well, I will say - it is free !!

A company needs technology for improvement in design, more better technology for mass production, cut cost, cut margins and it needs marketing efforts to proliferate its reach
Nevertheless, what is freely available in the efforts of perfection - are the innovative thoughts of systematic approach and logical methodologies. 

This is quality and it is free!!

FDA Proposes its Office in China

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 preferably at Hyderabad. However, what conspired in the galleries is not known.
This is despite of the fact, that recent Baxter’s Heparin case where four people died was originally manufactured in China.
As more and more Indian companies are inching towards generic drugs multinationals, the FDA is tightening its noose over these companies while relaxing its standards towards Chinese drug manufacturers where from sources known that getting a GMP certificate takes only 7 days!!!
It is not known that whether it is economic pressures, technological issues or the diplomatic appeasement.

When fears go wrong...

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 the glory of their past days operation in India. With nothing much to offer from their global new product basket, these companies continue to struggle over pricing issues.
To read the complete storey published in Economic Times, click here.

Integrated CAPA Approach, as a key model for Quality Systems

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 is good approach of reducing these identified deficiencies as a part of achieving total quality. I am giving the abstract of this article whereas to read the complete article and understand the integrated CAPA approach, click here.

Synopsis

Resolving problems and attempting to identify and prevent potential problems is a typical activity for most businesses. There are many business solutions available which promises to provide in-depth understanding of process and systems and thereby reduces or prevent potential problems. CAPA is one of such comprehensive fundamental management tool that provides a simple step by step process for completing and documenting corrective or preventive actions. CAPA focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their reoccurrence.To ensure that corrective and preventive actions are effective, the systematic investigation of the failure incidence is pivotal in identifying the corrective and preventive actions undertaken. The integrated CAPA model thus becomes a functional link between the overall deficiencies on one side, and their investigations and immediate corrective and preventive measures on the other side. The tool when implemented must have a vision and can provide controls needed to consistently produce a product of accepted quality. Therefore combining both the vision and controls together makes a comprehensive methodology for improvement over a period of time. CAPA thus becomes a functional link between the deficiencies on one side, and their investigations and immediate corrective and preventive measures on the other side and a year-by-year approach of reducing these identified deficiencies as a part of achieving total quality.

FDA Inspects wrong plant in China

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 there is no link established between the ingredient and the reactions of patients to the Heparin about which the FDA issued an alert, the revelation is sure to shake up agency critics on the Hill, as evidenced by the statement of Rep. Rosa DeLauro, D-Conn., chairwoman of the House Agriculture, Rural Development, Food and Drug Administration Appropriations Subcommittee who likened the FDA with the Keystone Cops in an ABC Evening News piece this week.
And we thought- it happens only in India !

Container & Closure Integrity in Lieu of Sterility Testing in Stability Protocol

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, recommending an alternative to sterility testing for supporting continued capability of containers to maintain sterility. The guidance does not apply to sterility testing methods for product sterility testing prior to release, as container and closure system integrity tests cannot demonstrate a product's initial sterility.Alternatives to sterility testing as part of the stability protocol,such as replacing the sterility test with container and closure system integrity testing, might include any properly validated physical or chemical container and closure system integrity test(e.g., bubble tests, pressure/vacuum decay, trace gas permeation/leak tests, dye penetration tests, seal force or electrical conductivity and capacitance tests, etc.),microbiological container and closure system integrity tests (e.g.,microbial challenge or immersion tests). The guidance can be dowloaded from:http://www.fda.gov/cber/gdlns/contain.htm . While the summary or review of this guidance can be read at: My reviews.

Integration of GMPs and Quality Management Systems - ICH Q10

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 Standard 9001.
The Quality System shall ensure conformity of each manufactured medicinal product with the quality as specified in the product's marketing authorisation / registration.
Elements like Corrective and Preventive Action (CAPA) and Continual Improvement are covered as well as Management responsibilities and Design Control.

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.

Merry Christmas to all !!!

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

The ASTM E2500 Standards..a go to "V"alidations!!!

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 the equipment and systems are ready to reliably manufacture a quality product; there are other aspects and documentation practices that clearly do not add this value. The basis of this standards is that the rigid rules that surrounds qualification (as practices today) can detract from its overall effectiveness.
The big change comes in the verification stage during the qualification process of this approach. ASTM E2500 states that verification is "A systematic approach to prove that critical elements acting singly or in combination, are fit for intended use, have been properly installed, and operating correctly". This verification would normally be documented in IQ, OQ and PQ documents however, the new approach just states that the verification approach must be documented. The extent of verification and the level of detail of documentation should be based on risk to product quality and patient safety. This approach also allows more flexibility if the design changes before the final acceptance with GEP change managed by and approved by subject matter expert (generally engineers).
After acceptance, GMP change is managed and approved by Quality. So another key factor of this approach is that things change and as long as they are managed and documented correctly this is acceptable.
While ASTM standard E2500 does much to eliminate the "folklore" wasteful practices such as excessive focus on documentation practices that have come to permeate qualifiaction, it also contains provisions that are not typically part of many projects, or if used, aren't given as much attendion as "GMP requirements", specification and design reviews, risk management and application of good engineering practices.

More information on ASTM E2500 can be taken from here.

KOEL Second Meet - Towards Maturity!!

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 and meet all old colleagues, I could not make it. But, the very thought of KOEL approaching towards maturity is exciting and as well as promising.

So, see you guys next time, in the third KOEL meet !