Folic acid is a naturally occurring substance that is important for the formation of red and white blood cells.

Package	Price	Per Item	Savings	Order
90 pills x 5 mg	$38.16	Only $0.42 per pill	You Save $0.00

Process Analytical Technology (PAT) has been defined by the Common States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the size of Critical Process Parameters (CPP) which affect Critical Quality Attributes (CQA).

The concept in reality aims at understanding the processes by defining their CPP's, and accordingly monitoring them in a favourable manner (preferably in-line or on-line) and thus being more efficient in testing while at the having said that time reducing over-processing, enhancing consistency and minimizing rejects.

The FDA has outlined a regulatory framework for PAT implementation. With this framework — according to Hinz — the FDA tries to drive the pharmaceutical industry to improve the production process. Because of the tight regulatory requirements and the protracted development time for a new drug, the production technology is "frozen" at the time of conducting phase-2 clinical trials.

In general, the PAT initiative from FDA is only one topic within the broader initiative of "Pharmaceutical cGMPs for the 21st century — A endanger based approach".

PAT implementation

The challenge to date with PAT for pharmaceutical manufacturers is artful how to start. A common problem is picking a complex process and getting mired in the challenge of collecting and analyzing the statistics.

The following criteria serve as a basic framework for successful PAT roll-outs: (From A PAT Primer)

• Picking a severe process. (Think Water for Injection (WFI) or Building Monitoring System (BMS)
• All details and nuances are in all probability understood and explained for that process.
• Determine what information is easily collected and available through current instrumentation.
• Understanding the appropriate intervals for collecting that statistics.
• Evaluating the tools available for reading and synchronizing the data.

PAT Tools

In order to piece of equipment a successful PAT project, a combination of three main PAT tools is essential:

• Multivariate matter acquisition and data analysis tools: usually advanced software packages which aid in Devise of Experiments, collection of raw data and statistically analyzing this data in order to find out what parameters are CPP.
• Process Analytical Chemistry (PAC) tools: in-line and on-line analytical instruments acclimated to to measure those parameters that have been defined as CPP. These register mainly Near infrared spectroscopy (NIRS); but also include biosensors, Raman spectroscopy, fiber optics and others.
• Connected improvement and/or knowledge management tools: paper systems or software packages which heap up Quality Control data acquired over time for specific processes with the aim of defining process weaknesses and implementing and monitoring process reform initiatives. These products may be the same or separated from the statistical analysis tools atop.

Long-term goals

The long term goals of PAT are to:

• reduce production cycling opportunity
• prevent rejection of batches
• enable real time release
• increase automation
• further energy and material use
• facilitate continuous processing

Currently NIR spectroscopy applications control the PAT projects. A possible next-generation solution is Energy Dispersive X-Ray Diffraction (EDXRD) . For a inclusive review of PAT tools see Scott , or Roggo .

Footnotes

1. ^ FDA , Guidance for industry: PAT — A framework for innovative pharmaceutical unfolding, manufacturing and quality assurance; September 2004
2. ^ Hinz , Process analytical technologies in the pharmaceutical industry: the FDA's PAT first move; Anal Bioanal Chem, Vol 384, p1036-1042, 2006
3. ^ FDA , Pharamaceutical cGMPs for the 21st century — A imperil based approach; Final Report, September 2004
4. ^ Williams, J: "Healthcare Distributor", recto 81. E.L.F. Publications, Inc., December 2006/January 2007
5. ^ Scott , Process analytical technology in the pharmaceutical industry: a toolkit for unbroken improvement; PDA Journal of Pharmaceutical Science and Technology, Vol 60, No 1, p17-53, 2006
6. ^ Roggo , A review of near infrared spectroscopy and chemometrics in pharmaceutical technologies Minute-book of Pharmaceutical and Biomedical Analysis, Volume 44, Issue 3, 27 July 2007, Pages 683-700

References

• FDA: PAT Hustle
• EMEA: Inspections - Process Analytical Technology
• ASTM PAT Committee
• PAT Seminars &
  We hope that the matter available here on Process Analytical Technology prove to be fruitful to you in your mission for enlightenment on Process Analytical Technology.

  Comments

  Previous Entries

  post date	category	title/description
  04.10.2009	Articles	ebooks trading
  04.10.2009	Articles	early pregnancy symptoms
  04.10.2009	Articles	druid sacred texts
  04.10.2009	Articles	driving after a tummy tuck
  04.10.2009	Articles	dr john briffa

  Post Comments

  Name Email Your Comments