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?

Deviations & CAPA remains hot topic in Audits

MHRA Publishes set of information from its database summarizing their observations to show deviations and CAPA remains the hot topic for inspectors during their regular GMP inspections.

While investigations of anomalies (deviations, OOS, OOTs) remains at the top, insufficient CAPA comes at third position.

MHRA has come forward to publish some of the reasons for this continuous concern over the years. These questions and relevant answers give a good overview and tips on how EU inspectors review QRM elements from ICH Q9 and Q10 and how do they enforce them.

The details presentation can be downloaded at, click here

The tips and frequently asked questions regarding inspectors approach towards QRM can be downloaded, click here

MHRA Publishes OOS FAQs

FDAs guidance on Out-of-specifications (OOS) is well known. Now Guidance from the MHRA on how to handle out-of-specification results during laboratory analysis is - on the contrary - pretty unknown although an own webpage on the MHRA website is dedicated to the OOS topic.

On the MHRA website, you can find a complete presentation on Out Of Specification Investigations. The presentation ends with the following statement: "Microbiological expectations will be provided at a later date."

These FAQs and interactive presentation provide guidance on what to do if an out of specification result is identified during laboratory analysis.

Click here to read and download the guidance.

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