Excipients to get Certification standards

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 safety of medicines for patients is paramount to all those involved in the supply chain. To assure the quality of medicines produced, risks in the supply chain need to be evaluated and minimized, and this includes not only active pharmaceutical ingredients (APIs) but also pharmaceutical Excipients.
At the same time, the major Excipients manufacturers are working hard to keep pace with the growing formulations, various delivery systems and technologies. Therefore, various important features are being considered in their Excipients product portfolio to influences Excipients role during formulations development. For example, BASF says role of solubility and bio availability will be key focus for its pharmaceutical excipient product development efforts for next few years.
Also the price rise among Excipients and cut throat competition compels their manufacturers to invent niche processes in shortest period of time, however maintaining the best quality for formulation development.
Going by the technologies and studies put into the Excipients development process, it was paramount that the regulatory agencies must have framed up GxP model for assessing quality for manufacturing these goods.
To download these standards, click here

Tablets Scoring. FDA release its guidance to industry

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 therefore exposed before consumption in next dosage. The dilemma remained and I tried to take precautionary measures. I knew it and so I did it, but what for those who are unaware of handling split fractions of tablets?

But my dilemma was over last week, when Ashish forwarded the new guidance for industry from FDA. This new guidance is on Tablets Scoring: its nomenclature, labeling and data for evaluation.

A good initiative as usual from the FDA. While the guidance will help people like me who may have to dispense broken tablets. The issues are related to dealing with modified released tablets, stability of split tablet, risks of impurity generation etc.

These are set of guidance’s and criteria for industry on which scored tablets characteristics will be evaluated as part of review process.

The guidance can be downloaded from the FDA site or click here.

EU GMP Guide: New Requirements added for Batch Certification

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 countries having appropriate arrangements on GMP, must be accompanied by a batch certificate issued by the manufacturer in the exporting country. In the framework of MRAs all manufacturing sites must be located in the country issuing the certificate or in another MRA country, if reciprocal arrangements are in force. In the framework of the European Union's ACAA with Israel (once in operation) all quality control sites must be located in Israel or the EU.
The respective certificate should be issued further to a full qualitative and quantitative analysis of all active and other relevant constituents to ensure that the quality of the products complies with the requirements of the marketing authorisation of the importing country. It shall attest that the batch meets the specifications and has been manufactured in accordance with the marketing authorisation of the importing country. The batch certificate should be signed by the person responsible for certifying that the batch is suitable for release for sale or supply/export. For the EU, that's the Qualified Person (QP).
Where applicable this batch certificate shall also be used for non-finished medicinal products such as intermediates, bulk or partially packed products.

The certificate may also be used for active pharmaceutical ingredients (API) and investigational medicinal products (IMP) used in clinical trial authorisations.

Click here to download the full document

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 ?