Experience Quality, not measure it.

I was reading an interesting title 'Quality is personal' which reminds me of my two years earlier post 'Quality is free'. Indeed the book I am reading is a best seller title of its own kind, and my post was influenced by a comment made by one of my earlier boss in a conference.

If Quality is personal, it is definitely free.

This require, an attitude towards perfection, beauty, satisfaction and so quality is indeed a sense of fulfillment.

However, within a world of consumerism, industrialization and the way concept of quality emerged and presented in text books of management, it is seen with a myopic view of improvement in processes, systems and calibration of machines or services to meet the specifications.

There is, nevertheless, another key lesson, which is the basis of beliefs. Quality as practices by the individual is the foundation on which total quality management is built. I recall an anecdote where in a sales executive who charge another couple of dollars for explaining how a digital watch works to her customer. While on the other hand, when the same customer happen to visit another country, he was given a free gift wrapping on a cheap gift item he purchased from that store. Delighted, he left the store with a smile and promise  to come back again if he happens to visit that country.

Quality can not be taught, it can only be experienced, learned and re-learned. There is however, no point of unlearning in quality. Experience Quality and do not measure it.

Steve Jobs during his various sessions in developing his elite gadgets, didn't like the models, crafting or whatsoever was brought in front of him. Simple, there was no reason, but he didn't like them. He was actually building quality into his products from his own eyes.

So, is quality an idea? a thought? an endeavor for evolution of mankind towards a better society?

Warning Letter, AIP to Consent Decree - Isn't it better to follow GMPs ?

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 expresses a voluntary agreement by the participants in a lawsuit. Sometimes a suit ends when a judge issues a consent decree, or a consent judgment. This is especially the case when the decree is issued after one side of the case voluntarily agrees to cease a particular action without admitting to any illegality of the action.

If a firm has repeatedly violated cGMP requirements, the FDA may make a legal agreement with the firm to force them to make specific changes; the agreement, the consent decree, is enforced by the federal courts. Usually, consent decrees include fines ("disgorgements"), reimbursements to the government for inspection costs, due dates for specific actions, and penalties for noncompliance. Consent decrees usually are permanent, but at times specified in the agreement when the firm has achieved compliance, it can petition the court to remove the decree.

Historically many companies have been a part of consent decree and notably are Schering & Plough, J& J.

More information can be obtained at click here

Thoughts, ideas and quality.

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 their correlation with quality.

Ideas emerge from thoughts and thoughts are numerous, continuous, useful or may be gibberish at times, but thoughts provide a good soil for ideas to grow. A thoughtful mind is full of ideas which are are instantaneous, triggered by passion for resolving issue or to find ways of moving forward.

Quality is perception towards object or happening. An idea is an impetus to this perception. Ideas emerge when there are thoughts. 

Quality of thoughts, design ideas and will generate same quality of ideas.

Audits - Boon or bane?

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 behind their back as department heads will often ignore, reject or delay the implementation of the recommendations being presented.

What do you say ? as an Auditor or as an Auditee ? The rudimentary question is continuous improvement, compliance to laid down regulations versus fast deliveries at the cost of ?

Is Quality an Idea ?

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 remember entering the room of a Manager of one pharma company which was tidy, neat and well maintained. The placement of pens and pencils in the pen holder, colours, sketch pens, books, charts and chair - in fact everything was wonderful. Or did I only think that was wonderful ? My attitude or his attitude ?

Alfred Nobel, so distress from his invention of dynamite, raised his wealth for an award - Nobel prize. He thought rather unusual - a quality thought? Does thoughts also have quality ?

But had he never had so much of wealth to offer, what Alfred would have done?? No money - no award. The quality of Life...

You never know - quality is multidimensional, multifaceted, omnipresent and mysteriously hidden in the seed of human thoughts - human thought which have the courage to raise this civilization! Is it?

Is quality an Idea ?

Readers Encourage me !

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 the requirements which are not recommended by any International guideline.

Change Room and Air Lock - Design & Layout

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 air-lock keeping outside air out and not allowing contamination to fly inside. Thus an airlock divides two different zones or classes of clean areas.
As Michael impressed on our discussions, I thought to share some of the useful bullet points emerging out of it.
Air lock connects two different environments, usually at different pressures, that enable personnel to transfer from one environment to the other.
An air lock is required when the particles from adjacent area is less clean than the clean-room of concern, therefore, the infiltration of particles can be minimized by controlling the air flow direction so that air flows from the clean room to its adjacent space (less clean). This can be easily accomplished by supplying more air than return air (++ condition), thus slightly pressurizing the room.
Above picture gives the schematic view of change room with requirement of pressure differentials across different zones.
See carefully the blue arrows for direction of air –flow, direction in which doors are opening and ‘+’ sign for pressure differentials.

In between Audits and Compliance.

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 look forward. Compliance is commitment and requires complete understanding of prevailing and intended systems.

In the absence of commitment or understanding of (prevailing or intended) systems, the purpose of Audit is defeated and Compliance is just a piece of show !

Moving forward with desires and despair

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 year went by was so chaotic that it condensed the enthusiasm of life.
If I recall some of the major headlines which remained in the news in 2008 from Pharma world then it would be :

• Continuing of Heparin case investigations and afterfall.
• Ranbaxy banned for Exporting 28 drug products from their 2 plants after FDA served Warning Letters.
• Ranbaxy acquired by Daiichi Sankyo of Japan.
• Melamine identified in Chinese dairy products.

I wish the coming year comes with lots of good news.

China and its Quality Control

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 after using the drugs made from Siberian ginseng. There are cases of contraindications when six people from south - western Yuan province administered these injections.

In the early 90's when India started its first generation reforms, the government choose Quality as its element of expanding exports. As a result, many Indian companies initiated the process of obtaining accreditation to ISO Management systems. However, for opening up of world economy, China choose to increase its manufacturing capabilities to reduce cost and capture world market.

It seems in the process of increasing production and focusing only on to the Manufacturing capabilities, the Chinese industry masters left quality and standards way behind.

The result are evident from these incidences - toys made by using hazardous chemical colours and deaths due to sub standard drug products.

Regulatory Agencies and the End of Innovation

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 same direction of innovation and gives logical interpretation of quality systems management. Though much of it has been said, but nothing substantial has moved on the floor - particularly in India!

ICH is primarily engaged in integrating the current global pharmaceutical quality and related philosophies and practices. However, the newly published ICH Q9 and Q10 speaks of something which was already existing into the innovation hungry pharmaceutical industry. The application of 'risk assessment' and 'quality systems' do not offer anything new. My view point on these developments is this, that it is almost a decade after the advent of 'International GMPs' in India, there is nothing new which is emerging. The cross-functional reviews and the system controls like - Change Control, Incidents handling, APQR and CAPA are still living their life to full.

I don't remember any regulatory inspector asking for the risk assessment details for any drug development process till its commercial launch!

The FDAs 21st century approach and PAT also emphasise on automation and innovation, but nothing substantial has really moved on these fronts at least in India. There appears few seminar brochures giving details on discussions on these topics, few articles appearing in prominent international journals - but nothing beyond that. I am not so sure of European and American companies for imbibing PAT into their regular practices.

The same is the fate of Six sigma or Lean management for pharma industry. We live with the concepts and when the implementation comes - we wait for the regulatory compulsions to arrive.

The question here is - why so many thoughts but no applications ? Have we reached the saturation in terms of implemneting quality systems? Does too much of expectations are distancing the innovation ?