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1906: Availability of panchromatic black and white film and therefore high quality color separation color photography. G+ #Read of the Day: The Daguerreotype - The daguerreotype, an early form of photograph, was invented by Louis Daguerre in the early 19th c. The first photograph (1826) - Joseph Niepce, a French inventor and pioneer in photography, is generally credited with producing the first photograph.
Easy Peasy Fact:Following Niepcea€™s experiments, in 1829 Louis Daguerre stepped up to make some improvements on a novel idea. The ICH Steering Committee (SC) will meet in Fukuoka, Japan from 6 to 11 June to discuss ongoing harmonisation activities.
The IPEC Federation (International Pharmaceutical Excipients Council) has published a three-page position paper concerning the risk-based approach of the EU Guidelines following the principles of Quality Risk Management according to ICH Q9.
For many years now, discussions have been ongoing as to whether it is possible to include non-distillation technologies as a method for the production of Water for Injections (WFI). The currently valid version of the EU GMP Guide  Annex 15 “Qualification and Validation” from 2001 will finally be replaced by 1 October 2015. With this GMP MANUAL UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations.
In a highly acclaimed talk held during our GMP Symposium, Richard Denk elucidated the risk factors for contamination and the influence of highly active substances. The European Medicines Agency (EMA) has released a Concept Paper on the Revision of Annex 1 of the Guidelines on Good Manufacturing Practice – Manufacture of Sterile Medicinal Products which addresses the need to update Annex 1 of the European GMP Guide. New versions of Chapter 3 (Premises and Equipment) and Chapter 5 (Production) have been published providing transitional arrangements for toxicological evaluation.
FDA Center for Drug Evaluation and Research (CDER) launched an Office of Pharmaceutical Quality (OPQ) as part of its ongoing Quality Initiative. The ICH Q3D Guideline on Elemental Impurities reached Step 4 of the ICH Process in December 2014 and now enters the implementation period (Step 5).
The US Food and Drug Administration (FDA) has just released a list of all new and revised draft guidances it plans to release in 2015.
The ICH Steering Committee (SC) and its Expert Working Groups (EWGs) met in Lisbon, Portugal on November 8–13, 2014. Before the end of the year the European Commission has published the “Commission Delegated Regulation (EU) No. The EMA has published the final version of the „Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”. A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorised original biological medicinal product (reference medicinal product) in the EEA. Officials of Australia and New Zealand have confirmed the plan to stop the development of the joint regulatory authority ANZTPA.
This month representatives of the FDA have met with their cross-agency team from the EMA, the European Commission and GMP experts form European Union Member States in London, in order to make progress on mutual reliance on GMP inspections.
ISPE released its Drug Shortages Prevention Plan during the 2014 Annual Meeting in Las Vegas, Nevada. This month the EMA released a “Reflection paper in the requirements for selection and justification of starting materials for the manufacture of chemical active substances”.
On 21 October 2014, the FDA released the final version of its Guidance for Industry entitled „Circumstances that constitute delaying, limiting, or refusing a drug inspection”. The ICH Steering Committee has endorsed the final concept paper Q12 “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management”. The use of products with non-declared pharmacological activity or “other illegal medicines”, often from uncontrolled sources but also purchased from the legal market, is still a major problem within Europe. From 10-11 September 2014, the second symposium on combating counterfeits and other illegal medicines took place at EDQM. The Active Pharmaceutical Ingredients Committee, APIC, has recently published a comprehensive How to do Document regarding electronic Common Technical Documents.
The European Commission has published a revised version of Part II of the EU GMP Guide – Basic Requirements for Active Substances used as Starting Materials. The EU’s decentralised procedure is being used as a model to accelerate the assessment of applications for generic medicines as part of the International Generic Drug Regulators PilotExternal link icon (IGDRP). The ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk has reached Step 4 of the ICH process and is now entering the implementation period (Step 5). FDAs Center for Drug Evaluation and Reseach (CDER) has published its yearly list of guidance documents and a list of new, revised and withdrawn guidances. Last week the FDA issued several policy documents regarding compounded drug products for human use, as part of the agency’s effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. EU regulators have unveiled a new logo which will appear on the websites of all authorised online pharmacies known to provide authentic medicines. The Australian Therapeutic Goods Administration (TGA) is set to strengthen its collaboration with the European Directorate for the Quality of Medicines and HealthCare (EDQM). EMA has published the long awaited Qualified Person (QP) declaration template and accompanying guidance concerning GMP compliance of API manufacture. The FDA, in partnership with other federal and international agencies, took action last week against websites that sell potentially dangerous, unapproved prescription drugs to U.S. As previously reported, the FDA is working on a system that will help to identify and trace dangerous drugs that are counterfeit, stolen or tainted throughout the whole supply chain.
This month, the WHO has published a proposal for the revision of the supplementary guidelines on GMP: Validation, namely Appendix 7 – non-sterile process validation. The European Commission has published the final version of Chapter 6 Quality Control of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use on April 3, 2014. The EMA has published the final version of the long awaited Guideline on Process Validation “Guideline on process validation for finished products – information and data to be provided in regulatory submissions” on February 24, 2014. The FDA has published a Draft Guideline for Industry entitled Analytical Procedures and Methods Validation for Drugs and Biologics. The FDA initiates the Secure Supply Chain Pilot Program to enhance the security of imported drugs. The CFDA has announced the adoption of the draft amendment to the Regulations for the Supervision and Administration of Medical Devices at the executive meeting of the State Council on February 12, 2014. As announced by the Swiss Regulatory Authority Swissmedic, a Memorandum of Understanding in the area of therapeutic products was signed with the Korean Ministry for Food and Drug Safety (MFDS). Shortly after the FDA notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products due to particularly serious GMP deficiencies, health agencies in Europe are evaluating the FDA inspection findings to assess if these deviations from GMP have any implication on medicines on the European market. The Health Ministry of India has constituted a sub-committee to prepare guidelines regulating the transportation of drugs in the country. Early this month, the China Food and Drug Administration (CFDA) issued an announcement on the implementation of the Good Manufacturing Practice for Drugs (2010 Revision) for sterile pharmaceutical products.
According to pharmabiz, the government of India is planning a revision of its GMP guidelines – Schedule M – and considers making them on par with the WHO-GMP standards. The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) published the results of their last meeting in Osaka: ICH Reviews Future ICH Topics and Its Organisation Towards Increased Engagement Globally. Talbot was active from the mid-1830s, and sits alongside Louis Daguerre as one of the fathers of the medium. Niepcea€™s photograph shows a view from the Window at Le Gras, and it only took eight hours of exposure time!The history of photography has roots in remote antiquity with the discovery of the principle of the camera obscura and the observation that some substances are visibly altered by exposure to light.
Again employing the use of solvents and metal plates as a canvas, Daguerre utilized a combination of silver and iodine to make a surface more sensitive to light, thereby taking less time to develop. The report was developed during a Member State Meeting on SSFFC in October 2014 in Geneva, Switzerland. Food and Drug Administration (FDA) has published their yearly list of new and revised draft guidances CDER is planning to publish in 2015.


Food and Drug Administration (FDA) issued five draft documents related to drug compounding and repackaging to help entities in complying with important health provisions. The EMA has published a revised version of the guideline "Guideline on similar biological medicinal products".
The report has been presented in a revised format, following comments from a stakeholder focus group. Delaying, refusing, denying – FDA inspectors often see themselves confronted with cooperation problems.
Representatives from forensic and customs laboratories, national medicines and food authorities, enforcement groups and the European Commission were invited to shed light on the problem of falsification of medicines. According to the EC this became necessary due to changes in various Annexes of the GMP Guide. FDA and the EMA (European Medicines Agency) announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. Porta (1541-1615), a wise Neapolitan, was able to get the image of well-lighted objects through a small hole in one of the faces of a dark chamber; with a convergent lens over the enlarged hole, he noticed that the images got even clearer and sharper. Though he is most famous for his contributions to photography, he was also an accomplished painter and a developer of the diorama theatre. As far as is known, nobody thought of bringing these two phenomena together to capture camera images in permanent form until around 1800, when Thomas Wedgwood made the first reliably documented although unsuccessful attempt. The draft documents apply to outsourcing facilities, federal facilities, pharmacies and physicians.
The regulation was issued on 25 November 2014 in the Official Journal of the European Union and has entered into force on 15 December 2014.
Schulze mixes chalk, nitric acid, and silver in a flask; notices darkening on side of flask exposed to sunlight. A daguerreotype, produced on a silver-plated copper sheet, produces a mirror image photograph of the exposed scene. Not only the new principles of ICH Q8, Q9, Q10 and Q11 constituted a new regulatory environment but also a continuous updating of Chapters of Part I of the EU GMP Guide or Annex 11 (computerised systems). The alchemist Fabricio, more or less at the same period of time, observed that silver chloride was darkened by the action of light. Chemistry student Robert Cornelius was so fascinated by the chemical process involved in Daguerrea€™s work that he sought to make some improvements himself.
Another important document to be mentioned in connection with the new Annex 15 is the EMA guidance on process validation. It was only two hundred years later that the physicist Charles made the first photographic impression, by projecting the outlines of one of his pupils on a white paper sheet impregnated with silver chloride.
It was commercially introduced in 1839, a date generally accepted as the birth year of practical photography.The metal-based daguerreotype process soon had some competition from the paper-based calotype negative and salt print processes invented by Henry Fox Talbot. And in 1839 Cornelius shot a self-portrait daguerrotype that some historians believe was the first modern photograph of a man ever produced. The photos were turned into lantern slides and projected in registration with the same color filters.
THESE VERY SAME ENFORCEMENT AGENCIES, WHO HAVE SWORN TO PROTECT AND SERVE, OUR COUNTRY, AND CITIZENS ,ARE BUT SOME, OF THE CORRUPT,GREEDY TRAITORS .ENGAGED IN THE TYRANNY AND TORTURE. In 1802, Wedgwood reproduced transparent drawings on a surface sensitized by silver nitrate and exposed to light. Nicephore Niepce (1765-1833) had the idea of using as sensitive material the bitumen, which is altered and made insoluble by light, thus keeping the images obtained unaltered.
Long before the first photographs were made, Chinese philosopher Mo Ti and Greek mathematicians Aristotle and Euclid described a pinhole camera in the 5th and 4th centuries BCE. He communicated his experiences to Daguerre (1787-1851) who noticed that a iodide-covered silver plate - thedaguerreotype -, by exposition to iodine fumes, was impressed by the action of light action, and that the almost invisible alteration could be developed with the exposition to mercury fumes.
In the 6th century CE, Byzantine mathematician Anthemius of Tralles used a type of camera obscura in his experimentsIbn al-Haytham (Alhazen) (965 in Basra a€“ c.
It was then fixed with a solution of potassium cyanide, which dissolves the unaltered iodine.The daguerreotype (1839) was the first practical solution for the problem of photography. In 1841, Claudet discovered quickening substances, thanks to which exposing times were shortened.
More or less at the same time period, EnglishWilliam Henry Talbot substituted the steel daguerreotype with paper photographs (named calotype).
Wilhelm Homberg described how light darkened some chemicals (photochemical effect) in 1694.
Niepce of Saint-Victor (1805-1870), Nicephorea€™s cousin, invented the photographic glass plate covered with a layer of albumin, sensitized by silver iodide. The novel Giphantie (by the French Tiphaigne de la Roche, 1729a€“74) described what could be interpreted as photography.Around the year 1800, Thomas Wedgwood made the first known attempt to capture the image in a camera obscura by means of a light-sensitive substance.
Maddox and Benett, between 1871 and 1878, discovered the gelatine-bromide plate, as well as how to sensitize it. As with the bitumen process, the result appeared as a positive when it was suitably lit and viewed.
A strong hot solution of common salt served to stabilize or fix the image by removing the remaining silver iodide. On 7 January 1839, this first complete practical photographic process was announced at a meeting of the French Academy of Sciences, and the news quickly spread.
At first, all details of the process were withheld and specimens were shown only at Daguerre's studio, under his close supervision, to Academy members and other distinguished guests.
Paper with a coating of silver iodide was exposed in the camera and developed into a translucent negative image.
Unlike a daguerreotype, which could only be copied by rephotographing it with a camera, a calotype negative could be used to make a large number of positive prints by simple contact printing. The calotype had yet another distinction compared to other early photographic processes, in that the finished product lacked fine clarity due to its translucent paper negative. This was seen as a positive attribute for portraits because it softened the appearance of the human face.
Talbot patented this process,[20] which greatly limited its adoption, and spent many years pressing lawsuits against alleged infringers.
He attempted to enforce a very broad interpretation of his patent, earning himself the ill will of photographers who were using the related glass-based processes later introduced by other inventors, but he was eventually defeated.
Nonetheless, Talbot's developed-out silver halide negative process is the basic technology used by chemical film cameras today. Hippolyte Bayard had also developed a method of photography but delayed announcing it, and so was not recognized as its inventor.In 1839, John Herschel made the first glass negative, but his process was difficult to reproduce.
The new formula was sold by the Platinotype Company in London as Sulpho-Pyrogallol Developer.Nineteenth-century experimentation with photographic processes frequently became proprietary.
This adaptation influenced the design of cameras for decades and is still found in use today in some professional cameras. The school district has moved to a biometric identification program, saying students will no longer have to use an ID card to buy lunch.A  BIOMETRICS TO TRACK YOUR KIDS!!!!!i»?i»?A TARGETED INDIVIDUALS, THE GREEDY CRIMINALS ARE NOW CONDONING THEIR TECH! Petersburg, Russia studio Levitsky would first propose the idea to artificially light subjects in a studio setting using electric lighting along with daylight.
In 1884 George Eastman, of Rochester, New York, developed dry gel on paper, or film, to replace the photographic plate so that a photographer no longer needed to carry boxes of plates and toxic chemicals around.
Now anyone could take a photograph and leave the complex parts of the process to others, and photography became available for the mass-market in 1901 with the introduction of the Kodak Brownie.A practical means of color photography was sought from the very beginning. Results were demonstrated by Edmond Becquerel as early as 1848, but exposures lasting for hours or days were required and the captured colors were so light-sensitive they would only bear very brief inspection in dim light.The first durable color photograph was a set of three black-and-white photographs taken through red, green and blue color filters and shown superimposed by using three projectors with similar filters. It was taken by Thomas Sutton in 1861 for use in a lecture by the Scottish physicist James Clerk Maxwell, who had proposed the method in 1855.[27] The photographic emulsions then in use were insensitive to most of the spectrum, so the result was very imperfect and the demonstration was soon forgotten.


Maxwell's method is now most widely known through the early 20th century work of Sergei Prokudin-Gorskii. Included were methods for viewing a set of three color-filtered black-and-white photographs in color without having to project them, and for using them to make full-color prints on paper.[28]The first widely used method of color photography was the Autochrome plate, commercially introduced in 1907. If the individual filter elements were small enough, the three primary colors would blend together in the eye and produce the same additive color synthesis as the filtered projection of three separate photographs. Autochrome plates had an integral mosaic filter layer composed of millions of dyed potato starch grains.
Reversal processing was used to develop each plate into a transparent positive that could be viewed directly or projected with an ordinary projector. The mosaic filter layer absorbed about 90 percent of the light passing through, so a long exposure was required and a bright projection or viewing light was desirable.
Competing screen plate products soon appeared and film-based versions were eventually made.
A complex processing operation produced complementary cyan, magenta and yellow dye images in those layers, resulting in a subtractive color image. Kirsch at the National Institute of Standards and Technology developed a binary digital version of an existing technology, the wirephoto drum scanner, so that alphanumeric characters, diagrams, photographs and other graphics could be transferred into digital computer memory.
The lab was working on the Picturephone and on the development of semiconductor bubble memory.
The essence of the design was the ability to transfer charge along the surface of a semiconductor. Michael Tompsett from Bell Labs however, who discovered that the CCD could be used as an imaging sensor. Paul Weindling, history of medicine professor at Oxford Brookes University, describes his search for the lost victims of Nazi experiments. The chairman of the board at ESL a€” then proprietor of the desert wasteland in Nevada known as a€?Area 51a€? a€” was William Perry, who would be appointed secretary of defense several years later. EUCACH.ORG PanelIn a 2-hour wide-ranging Panel with Alfred Lambremont Webre on the Transhumanist Agenda, Magnus Olsson, Dr. Henning Witte, and Melanie Vritschan, three experts from the European Coalition Against Covert Harassment, revealed recent technological advances in human robotization and nano implant technologies, and an acceleration of what Melanie Vritschan characterized as a a€?global enslavement programa€?.Shift from electromagnetic to scalar wavesThese technologies have now shifted from electromagnetic wave to scalar waves and use super quantum computers in the quantum cloud to control a€?pipesa€? a reference to the brains of humans that have been taken over via DNA, via implants that can be breathed can breach the blood-brain barrier and then controlled via scalar waved on a super-grid. Eventually, such 'subvocal speech' systems could be used in spacesuits, in noisy places like airport towers to capture air-traffic controller commands, or even in traditional voice-recognition programs to increase accuracy, according to NASA scientists."What is analyzed is silent, or sub auditory, speech, such as when a person silently reads or talks to himself," said Chuck Jorgensen, a scientist whose team is developing silent, subvocal speech recognition at NASA Ames Research Center in California's Silicon Valley. We numbered the columns and rows, and we could identify each letter with a pair of single-digit numbers," Jorgensen said. People in noisy conditions could use the system when privacy is needed, such as during telephone conversations on buses or trains, according to scientists."An expanded muscle-control system could help injured astronauts control machines. If an astronaut is suffering from muscle weakness due to a long stint in microgravity, the astronaut could send signals to software that would assist with landings on Mars or the Earth, for example," Jorgensen explained. These are processed to remove noise, and then we process them to see useful parts of the signals to show one word from another," Jorgensen said.After the signals are amplified, computer software 'reads' the signals to recognize each word and sound. Our Research and Development Division has been in contact with the Federal Bureau of Prisons, the California Department of Corrections, the Texas Department of Public Safety, and the Massachusetts Department of Correction to run limited trials of the 2020 neural chip implant. We have established representatives of our interests in both management and institutional level positions within these departments. Federal regulations do not yet permit testing of implants on prisoners, but we have entered nto contractual agreements with privatized health care professionals and specified correctional personnel to do limited testing of our products.
We need, however, to expand our testing to research how effective the 2020 neural chip implant performs in those identified as the most aggressive in our society.
In California, several prisoners were identified as members of the security threat group, EME, or Mexican Mafia. They were brought to the health services unit at Pelican Bay and tranquilized with advanced sedatives developed by our Cambridge,Massachussetts laboratories. The results of implants on 8 prisoners yielded the following results: a€?Implants served as surveillance monitoring device for threat group activity. However, during that period substantial data was gathered by our research and development team which suggests that the implants exceed expected results. One of the major concerns of Security and the R & D team was that the test subject would discover the chemial imbalance during the initial adjustment period and the test would have to be scurbbed. However, due to advanced technological developments in the sedatives administered, the 48 hour adjustment period can be attributed t prescription medication given to the test subjects after the implant procedure.
One of the concerns raised by R & D was the cause of the bleeding and how to eliminate that problem. Unexplained bleeding might cause the subject to inquire further about his "routine" visit to the infirmary or health care facility. Security officials now know several strategies employed by the EME that facilitate the transmission of illegal drugs and weapons into their correctional facilities.
One intelligence officier remarked that while they cannot use the informaiton that have in a court of law that they now know who to watch and what outside "connections" they have. The prison at Soledad is now considering transferring three subjects to Vacaville wher we have ongoing implant reserach. Our technicians have promised that they can do three 2020 neural chip implants in less than an hour. Soledad officials hope to collect information from the trio to bring a 14 month investigation into drug trafficking by correctional officers to a close. Essentially, the implants make the unsuspecting prisoner a walking-talking recorder of every event he comes into contact with. There are only five intelligence officers and the Commisoner of Corrections who actually know the full scope of the implant testing. In Massachusetts, the Department of Corrections has already entered into high level discussion about releasing certain offenders to the community with the 2020 neural chip implants. Our people are not altogether against the idea, however, attorneys for Intelli-Connection have advised against implant technology outside strick control settings.
While we have a strong lobby in the Congress and various state legislatures favoring our product, we must proceed with the utmost caution on uncontrolled use of the 2020 neural chip. If the chip were discovered in use not authorized by law and the procedure traced to us we could not endure for long the resulting publicity and liability payments. Massachusetts officials have developed an intelligence branch from their Fugitive Task Force Squad that would do limited test runs under tight controls with the pre-release subjects. Correctons officials have dubbed these poetnetial test subjects "the insurance group." (the name derives from the concept that the 2020 implant insures compliance with the law and allows officials to detect misconduct or violations without question) A retired police detective from Charlestown, Massachusetts, now with the intelligence unit has asked us to consider using the 2020 neural chip on hard core felons suspected of bank and armored car robbery. He stated, "Charlestown would never be the same, we'd finally know what was happening before they knew what was happening." We will continue to explore community uses of the 2020 chip, but our company rep will be attached to all law enforcement operations with an extraction crrew that can be on-site in 2 hours from anywhere at anytime.
We have an Intelli-Connection discussion group who is meeting with the Director of Security at Florence, Colorado's federal super maximum security unit. The initial discussions with the Director have been promising and we hope to have an R & D unit at this important facilitly within the next six months. Napolitano insisted that the department was not planning on engaging in any form of ideological profiling. I will tell him face-to-face that we honor veterans at DHS and employ thousands across the department, up to and including the Deputy Secretary," Ms. Steve Buyer of Indiana, the ranking Republican on the House Committee on Veterans' Affairs, called it "inconceivable" that the Obama administration would categorize veterans as a potential threat.



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