The jews were pretty siccesseful in obtaining what they want just becosue the ruling majority in th eworld were gentical idiots, and of course were ignorant, greedy and horny.

The jews managed to build a base for their madness only on prostitution and corruption in general.

The last step was the construction of th ethree churches based on completely crazy bullshit like the Bible - Koran - Tora.

The last hope of th ewhole conscius human kind was the Russian empire, who stood as long as it was physicly possible thanks to the brute strength of th erussian people.

WHat do you consider to be the real data of the beginning of the end of the human conscius civilization on earth?

1 - The secret invasion of the jews on the Russian territory? Where they managed to mesmerize themselves in order to look similar to the russians?

2 - The building oif th ejewish church on the Russian territoy? IN odrer tpp start th eproliferation of the sons of prostitutes?

3 - The 1917 revolution hwere the jews took power over russia by commanding their sons of prostitutes and making escape all the educate drussians from their country?

Flexibility of the GMP
Manufacturers should use good judgment when developing their quality system and apply those sections of the QS regulation that are applicable to their specific products and operations, 21 CFR 820.5 of the QS regulation. Operating within this flexibility, it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, and distribute devices that meet the quality system requirements. FDA has identified in the QS regulation the essential elements that a quality system shall embody for design, production and distribution, without prescribing specific ways to establish these elements. Because the QS regulation covers a broad spectrum of devices and production processes, it allows some leeway in the details of quality system elements. It is left to manufacturers to determine the necessity for, or extent of, some quality elements and to develop and implement specific procedures tailored to their particular processes and devices. For example, if it is impossible to mix up labels at a manufacturer because there is only one label or one product, then there is no necessity for the manufacturer to comply with all of the GMP requirements under device labeling.
The medical device QS regulation requires an "umbrella" quality system intended to cover the design, production, and distribution of all medical devices from simple surgical hand tools to very complex computerized axial tomography (CAT) scanners. It is not practical for a regulation to specify details of quality system elements for such a wide range of products. Rather, the QS regulation specifies general objectives such as use of trained employees, design reviews, design validation, calibrated equipment, process controls, etc., rather than methods, because a specific method would not be appropriate to all operations.
In most cases, it is left to the manufacturer to determine the best methods to attain quality objectives. In some cases, however, the QS regulation does specify the particular type of method to be used, such as written procedures or written instructions. This does not mean, however, that manufacturers cannot vary from the method specified if the intent of the GMP requirement can be met by another method such as using an engineering drawing plus a model device as manufacturing instructions. Written procedures are not restricted to paper copies. Written procedures may be filed and distributed by automated data processing equipment. This flexibility is allowed by section 21 CFR 820.180.
Typically, large manufacturers will have a quality system that exceeds the medical device QS regulation. Small manufacturers will typically have a proportionally simpler system. FDA recognizes that a small manufacturer may not need the same amount of documentation that a large manufacturer does in order to achieve a state?of?control; and, that some of the records maintained to fulfill the GMP requirements for written procedures may not be as long and complex for a small manufacturer.
After a manufacturer establishes a quality system, it should be maintained. Each manufacturer should assure that with growth and process or product changes their quality system is still adequate. This assurance is obtained through change control, day?to?day observance of operations, and by periodic audits of the quality system. The auditor should first identify the elements of the company's quality system. Next the audit should determine how well each element is functioning, and then determine its adequacy with respect to the intent of the device GMP requirements and meeting the company's quality claims.
Applicability of the GMP
The QS regulation applies to finished devices intended to be commercially distributed for human use unless there is an approved exemption in effect. GMP exemptions are codified in the Classification Regulations 21 CFR 862 to 892. The exemption of most Class I devices from design controls is in section 21 CFR 820.30 (a).
Certain components such as blood tubing and major diagnostic x?ray components are considered by FDA to be finished devices because they are accessories to finished devices. The manufacturer of such accessories is subject to the QS regulation when the accessory device is labeled and sold separately from the primary device for a health?related purpose to a hospital, physician, or other user.
The designation of a device as a "custom" or "customized" device does not confer a GMP exemption.
Contract manufacturers and specification developers shall comply with the sections of the QS regulation that apply to the functions they perform.
Contract test laboratories are considered an extension of a manufacturer's quality system and presently are not routinely scheduled for GMP inspections. The finished device manufacturer shall meet the requirement of the QS regulation, particularly 21 CFR 820.50, Purchasing, when they obtain products or services. Internal test laboratories, however, that are part of a corporate manufacturer that provides services to individual corporation factories should meet GMP requirements. Internal laboratories are inspected as part of the FDA GMP inspection of the member factories.
Situations are discussed in the remainder of this chapter where various manufacturers are exempt from the QS regulation or are not routinely inspected. However, these manufacturers are still subject to the FD&C Act. If these manufacturers or any manufacturer render devices unsafe or ineffective, the devices are adulterated and/or misbranded and the manufacturers are subject to the penalties of the FD&C Act.
GMP Exemptions
FDA has determined that certain types of establishments are exempt from GMP requirements; and FDA has defined GMP responsibilities for others. Exemption from the GMP requirements does not exempt manufacturers of finished devices from keeping complaint files ( 21 CFR 820.198) or from general requirements concerning records 21 CFR 820.180. Sterile devices are never exempted from GMP requirements. Medical devices manufactured under an investigational device exemption (IDE) are not exempt from design control requirements under 21 CFR 820.30. A device that normally would be subject to GMP requirements may be exempt under the following conditions:
When FDA has issued an exemption order in response to a citizen's petition for exemption;
When FDA, in the absence of a petition, has exempted the device and published the exemption in the Federal Register;
When the device is exempted by FDA classification regulations published in the Federal Register and codified in 21 CFR 862 to 892;
When the device is an intraocular lens (IOL) under an IDE and meets the requirements of the IDE regulation for IOL's (except for design controls 21 CFR 820.30); and
Through a policy statement, FDA may decide not to apply GMP requirements to some types of devices and processes although the devices may not have been exempted from GMP requirements.
Manufacturers should be aware of the GMP exemption status of their devices. In addition, manufacturers should keep on file records of any specific GMP exemption granted to them by FDA. Upon request during a factory visit, the exemption records need to be shown during normal business hours to the FDA investigator in order to verify that an exemption has been granted.
Types of Establishments Exempt from GMP
Component Manufacturers
A "component" is defined by 21 CFR 820.3 (c) as "any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device." Component manufacturers are excluded from the QS regulation by 21 CFR 820.1 (a)(1). Current FDA policy is to rely upon the finished device manufacturer to assure that components are acceptable for use. Component manufacturers are not routinely scheduled for GMP inspections; however, FDA encourages them to use the QS regulation as guidance for their quality system.
When finished device manufacturers produce components specifically for use in medical devices they produce, whether in the same building or another location, such production of components is considered part of the device manufacturing operations, and the production should comply with the QS regulation as detailed under Manufacturers of Accessories .
Types of Establishments Subject to the GMP

how many threads are there about this? AND HOW MANY FUCKING TIMES ARE THEY POORLY WRITTEN WITHOUT PARAGRAPHS????????????????

The jews were pretty siccesseful in obtaining what they want just becosue the ruling majority in th eworld were gentical idiots, and of course were ignorant, greedy and horny.

The jews managed to build a base for their madness only on prostitution and corruption in general.

The last step was the construction of th ethree churches based on completely crazy bullshit like the Bible - Koran - Tora.

The last hope of th ewhole conscius human kind was the Russian empire, who stood as long as it was physicly possible thanks to the brute strength of th erussian people.

WHat do you consider to be the real data of the beginning of the end of the human conscius civilization on earth?

1 - The secret invasion of the jews on the Russian territory? Where they managed to mesmerize themselves in order to look similar to the russians?

2 - The building oif th ejewish church on the Russian territoy? IN odrer tpp start th eproliferation of the sons of prostitutes?

3 - The 1917 revolution hwere the jews took power over russia by commanding their sons of prostitutes and making escape all the educate drussians from their country?

You need help.

actually, just get laid dude.

You need help.

actually, just get laid dude.

Do I need to get laid with your sister dude?

Becouse you see, I don't have a sister for my own.

And frankly, risking being buttfucked and die in pain is not worth getting lied a couple of times dude.

Lol.

Jews have some control but so do Christians and in the middle east look at the arabs. look at their city of Dubai. It's the future of all cities.

There are corrupt Jews out there (few) in general but don't blame the religion. A lot of these Jews that are corrupt are the ones running the show which makes me believe they're not practicing their religion properly. You should meet a jewish girl and make love to her. It will take at least half the hate for jews out of you. But yeah, Feel free to hate just as long as you hate someone in every group including your own.

I'm pretty pissed off at things in the world as well. But those new rules in place will change for some other oppressive rule. And so on. Actually, You should find some really good marijuana and smoke it. smoke it for the medical reason that you're really stressed right now and you're not in the zone of life.

OK?

tl;dr???



:p:p

...managed to destroy the world.
Pretty sure we're still here.

I live in Baltimore around MANY Jewish people and I can tell you with complete certainty that all they've really mastered is fussiness.

If you want to imagine some big scary overlord whom you think somehow has the power to control the world, you could pick a much better boogeyman than the Jews.

lol nice theory i love it.

Im not a racist so let me clarify what your saying.

I dont think a "jew" is out to take over the world. I know one person who is jewish and works on in the Fire Department. Is he going to take over the world? I doubt it very much. What I think you mean is instead of the Jews I think you mean The Zionists. Yes, the zionists have been very successful. Keep in mind however, that Zionists dont have to be Jewish they can be Christians as well. Joe Biden is an admitted Zionists yet he is no jew. Same with Obama.

The Zionists are part of AIPAC which lobbies America to death to be a Pro-Israel Friend leaving an obvious bias towards The Arabs who are not on friendly terms with Israel. Than when a terrorist comes over and blows himself up or when we watch the news we wonder why are we the victims? Because, the Zionists lobby us to death... The Zionists control our media so when we hear Iranian PM saying "Death To America and Death To Israel" what he really means to say is "Death to The Zionist Machine Controlling America." The Zionists have destroyed the world... People who will shit over anyone Israel tells them to because, they believe Israel is more special than any other country in the region.

I think Israel needs to be humbled, America needs to stay the fuck out of there so than that way Israel can actually reach a peace deal with the region.

I always considered myself a Zionist as well because I believe in the scripturess which say Israel belongs to the Jewish people but I have to question whether or not those in Israel are truly Jews or if they're using the religion to gain wealth and power. But don't get me wrong, i don't think it is every jew in Israel. I think it's the system in place. And they may not even be human let alone Jewish.

Ya jews are piece's of shit

I look forward ,keenly, to when Slave checks in and tears a new one for some of these ignorant racist morons.

Im not a racist, Im not a big fan of Israel bribing out congress to be biased towards the Israelis and look the other way while Israel shits all over the Palestians, I think some 290 people are dead in Gaza Strip after this weekend bombing run and what does the man of Change, Mr. Barack Obama have to say "No Comment!" Yet, when our media makes russia look like they invaded georgia even though georgia invade south ossetia what do we get? "Russia is bad, we disapprove of what Russia had done." Please, theres a bias factor in this freakin news thats so pro-israel it makes me mad.

Likewise, the one who said that that they consider themselves a Zionist because the Bible told them to, I have this to say: America is a secular nation we cannot have a bias towards one religion over the other. If thats the case I could say that at least the Muslims acknowledge that Christ was an important man, the Jews gave him nothing. You see how such comments lead to conflict? Be secular dont get involved in other nations problems. Sometimes the most moral thing to do is to say "No!" That couldnt go any clear than with AIPAC.