Process Validation Protocol and Report free essay sample

To trigger changes in the validation strategy if there is any unanticipated developments d. A written validation protocol is also a basic requirement of regulatory agencies. What is a Validation Report? The validation report is a comprehensive summary that documents how the validation plan has been satisfied. The validation report should document the detailed results of the validation effort, including test Results. Wherever possible, test results should be expressed in quantified form rather than expressed as pass/fail. The report should be reviewed and approved by designated Management or departments responsible for the validation more specifically validation team. What constitutes a validation report? and in some cases acts as a communication tool it is recommended by regulatory agencies that a summary be used to communicate the outcome of the validation performed this where a documented report is necessary to prove that a validation is successfully accomplished according to the specified validation plan. We will write a custom essay sample on Process Validation Protocol and Report or any similar topic specifically for you Do Not WasteYour Time HIRE WRITER Only 13.90 / page The validation report should contain the following. 1 . Approved validation protocol. 2. Tabulated or graphical results, process monitoring (forms), and all analytical results of the validation batches. 3. A copy of the batch records and raw material releases. 4. The presentation of data should be done in the report and be easily understood and neat. 5. Special investigations or additional tests or retests to be explained in the report. 6. Change controls and Deviations to be reported. . The validation report should have a conclusion. 8. Recommendations may also be made in the report History of validation protocol and report: Why validation and the associated validation protocol and report gained importance, elow mentioned is the brief history of the validation and its associated system Prior to 1978 the pharmaceutical manufacturing was highly regulated, drug product quality and sterility testing was based solely on finished product testing i. e. t was tested only at the final stage of the release drug product this was clearly a major setback. For Sterile products USP Sterility Testing was the sole criteria for releasing the drug product in to the market. The following incidents shows the defect in the above criteria USP sterility -rest Defect Rate 1% 5% Detection Probability 95% Batch Size 60,000 units Source- United states code for federal regulations. in 1962 and the Septicemia in 1970s. Septicemia outbreaks are considered as the greatest incident. Sterility problems arose in this incident as the large volume parenterals (LVP) failed for sterility this led to 54 deaths and 410 serious injuries FDA inspections came into force leading to product recalls and plant closure. This led FDA to seriously look in to the aspects of LVP and SVP (Small volume parenterals) facilities problems, inadequate process specifications, SOPs and test data, No EM specs, sops, and test data. In 1976 FDA proposed changes to the GMPs due to the outbreak of these incidents focused on Sterilization Procedures, Steam and Dry Heat Sterilization, ETO, Depyrogenation, SIP, and filtration. Terms such as Validation, Protocol, and Qualification began to be used this can be considered as the seed for the implementation of validation and thus the introduction of concepts like process validation protocol and report. A validation protocol is a detailed document relating to a specific part of the validation process e. g. the OQ for a manufacturing vessel. It outlines the tests that re to be carried out, the acceptance criteria and the information that must be recorded. It also defines the approval process for the validation. The protocol should clearly describe the procedure to be followed for performing validation. It should include at least the objectives of the validation and qualification study, the site of the study, the responsible personnel, a description of the equipment to be used (including calibration before and after validation), SOPs to be followed (e. g. the operation and cleaning of the equipment) and the standards and criteria for the relevant products and processes. The type of validation and time/frequency should also be stipulated. The processes and/or parameters to be validated (e. g. mixing times, drying temperatures, particle size, drying times, physical characteristics, content uniformity, etc. ) should be clearly identified. The results obtained during the performance of the validation, must be recorded. The validation report reflects the final test results and other documents such as instrument calibration certificates. It is on the basis of this report that the decision is taken on whether a particular process is Judged to be validated. During the inspection, you must assess whether there is a written report reflecting the results after completion of the validation. The results should have been evaluated, analyzed and compared with acceptance criteria by the responsible personnel. All results should meet the criteria of acceptance and satisfy the stated objective. If necessary, further studies should have been performed. If the results were found to be acceptable, the report should been approved and authorized (signed and dated). protocol, details of material, equipment, programs and cycles used, together with etails of procedures and test methods. It should provide a comparison of the results with the acceptance criteria. In addition, it should include recommendations on the limits and criteria to be applied to all future production batches. It is common practice in many companies for the protocol and the report to be combined into a single set of documents. The protocol is approved as a form on which the test results are recorded as they become available. This reduces the amount of paperwork that needs to be stored and makes an overall assessment of the validation results easier to carry out.

Free Essays on Comparison With Iago And Cassio

In the play â€Å"Othello,† one of William Shakespeare’s six tragedies, characters Iago and Cassio are similar and different in many ways. One of the ways Iago and Cassio are similar is through Othello himself. Both Iago and Cassio want to be on the good side of friend Othello, but both don’t have the same reasons. In Iago’s case with Othello, Iago wants to be on Othello’s good side so Othello wouldn’t be suspicious of what he was doing behind his back, such things as getting Cassio and Desdemona closer together so Othello would suspect something. Now in Cassio’s case, he just wants to be on Othello’s good side because he wants to be there. Cassio is Othello’s Lieutenant and he wants to stay that way, so after Cassio gets on Othello’s bad side, he tries his hardest to try and get back on his good side to keep Othello’s respect for him and the Lieutenant position. Both men wanted to be on Othello’s good side. Iago and Cassio both feel that they can trust one another. In the play, Iago trusts Cassio in his actions to do what he implies Cassio what to do, such as when Iago tells Cassio that he should talk to Desdemona to try and get in good terms with Othello. Iago also trusted Cassio’s actions when Othello overheard the conversation between Cassio and Iago. Iago knew that Cassio would talk about something else, and knew that Othello would interoperate it differently. Now Cassio is a different story. Cassio trusts Iago’s advice in trying to get himself on Othello’s good side. Cassio trusted Iago’s advice when Iago told him to go and keep talking to Desdemona about trying to get himself in good terms with Othello. It was a bad move in trusting Iago, but that’s what he did. Those two both trusted each other but in different ways which makes them two some what similar. The difference between these two is both have very different personalities. Iago’s personality is charming but in a crude way. He knows ... Free Essays on Comparison With Iago And Cassio Free Essays on Comparison With Iago And Cassio In the play â€Å"Othello,† one of William Shakespeare’s six tragedies, characters Iago and Cassio are similar and different in many ways. One of the ways Iago and Cassio are similar is through Othello himself. Both Iago and Cassio want to be on the good side of friend Othello, but both don’t have the same reasons. In Iago’s case with Othello, Iago wants to be on Othello’s good side so Othello wouldn’t be suspicious of what he was doing behind his back, such things as getting Cassio and Desdemona closer together so Othello would suspect something. Now in Cassio’s case, he just wants to be on Othello’s good side because he wants to be there. Cassio is Othello’s Lieutenant and he wants to stay that way, so after Cassio gets on Othello’s bad side, he tries his hardest to try and get back on his good side to keep Othello’s respect for him and the Lieutenant position. Both men wanted to be on Othello’s good side. Iago and Cassio both feel that they can trust one another. In the play, Iago trusts Cassio in his actions to do what he implies Cassio what to do, such as when Iago tells Cassio that he should talk to Desdemona to try and get in good terms with Othello. Iago also trusted Cassio’s actions when Othello overheard the conversation between Cassio and Iago. Iago knew that Cassio would talk about something else, and knew that Othello would interoperate it differently. Now Cassio is a different story. Cassio trusts Iago’s advice in trying to get himself on Othello’s good side. Cassio trusted Iago’s advice when Iago told him to go and keep talking to Desdemona about trying to get himself in good terms with Othello. It was a bad move in trusting Iago, but that’s what he did. Those two both trusted each other but in different ways which makes them two some what similar. The difference between these two is both have very different personalities. Iago’s personality is charming but in a crude way. He knows ...

Becoming Wonderful; Leaving Wonderland

Telling stories of Alice’s greatadventures, I stand in my ninth grade english classroom, a desolate young girl whose only passion is to be a writer, yet here she stands performing someone else’s work. The desks sit in a broad semi-circle, taking much inspiration from a greek theatre and I stand at the center of it all, performing a Lewis Carroll poem. My voice shakes sending shivers down my spine as I preform. The timid, tiny thirteen year old I was wanted nothing more than to show my class that I was a writer and somehow, I thought I could convey that by reading someone else’s work. Nonetheless, when my teacher asked who wanted to compete in the school wide poetry competition, I couldn’t even raise my hand. I just let my ambition slowly cease out. That was one of the few opportunities I had to express my passion for writing and literature in my first two years of high school. However, it wasn’t the lack of opportunity that shook me, it was the fact that opportunities wouldn’t be handed to me, it was the first time I realized that if I wanted something to happen, I had to go for it. For a while, I let this tsunami of self-doubt forecast in my life, throwing me briefly off course. As I felt myself sinking further done a rabbit hole of loneliness and disparity. I slowly seemed to find myself crying an ocean of tears that I would soon drown in. I didn’t want the inevitable to be true. Thankfully, I quickly realized there are two ways out of this rabbit hole: 1. I stay, still, where I am, never expressing my writing, waiting for opportunity or 2. Express my writing, take each opportunity and run with it, get out of the rabbit hole with self-determination. With this realization, I shifted my point of view, to option two. I wrote my pain into sonnets and stories that, in tenth grade,I was finally able to preform in front of my class with no shivers just utter confidence. I took the lessons I had learned in freshman and sophomore year, and thoroughly applied them throughout my junior year. I began submitting stories to competitions, I applied for newspaper, and tried out for slam poetry. I did things that would never have happened to me in the ninth grade because I didn’t wait for them to happen — I made them happen. Now, I can say: I am a writer. I am not just a girl too scared to perform someone else’s work or a girl whose work is filled by her pain; but a girl whose pain inspired her work, whose fear only pushes her farther out of her box. Out of that box and on to a stage, I stand, the theater seats filled to it’s brim with almost 400 hundred people, I approach the stage, the bright, white lights nearly b lind me but I don’t let it deter me. Now I can’t see anyone’s face but even if I could I don’t think I would shake. Today, I can stand, in front of a microphone, in front of a much larger audience. Not performing someone else’s poem. I am preforming my own work.

CDBM Essay Example | Topics and Well Written Essays - 4000 words

CDBM - Essay Example influenced by: the country’s accession to the WTO; economic development; creation of a middle class; Westernized culture; and technological advancements like the internet. The industry players have been prompt in taking into account the social and cultural diversity issues in the country through their efforts in creating an efficient marketing mix and adding value added features to suit the need of every possible market segment. However, this can be further enhanced by the employment of strategies which recognizes the different profiles of customers in each key cities and emphasizing on the promotion of health benefits from coffee products. The existence and mere survival of an industry lies in its ability to efficiently respond to the internal and external influences. It is irrefutable that business organizations’ strategies mirror their unique responses to the external challenges and opportunities in the environment which, in turn, is facilitated by their internal resources and competences. This paper will concentrate on the responses of the China specialty coffee industry to the various internal and external influences that it currently faces. Recognizing that this sector can be properly examined through the use of different strategic management tools, this report will be utilizing famous technique PEST Analysis for the external environment scanning. Meanwhile, the internal environment will be assessed through the identification of its various stakeholders through the Porter’s Five Forces Model. The next section will focus on the Chinese specialty coffee market responses in the face of social and cultural diversity. This report will thoroughly examine the impact of the social and cultural trends in the industry’s strategies while assessing the efficacy if their responses. Lastly, recommendations for improvement will be identified. Gaining the traditional recognition of being a tea country, marketers are aggressively and strategically transforming

What are some of the reasons given in the article for the achievement Essay

What are some of the reasons given in the article for the achievement gap in education in the United States what do you think could solve the problem discussed in the reading - Essay Example According to Robert Reich, a professor of public policy at the University of California and the author of ‘Beyond Outrage’, the average SAT-type tests between children in the richest ten percent and the bottom ten per cent was about ninety points on an eight hundred point scale thirty years ago. This has nevertheless increased to one hundred and twenty five points today a scenario which depicts the increasing achievement gap between the children coming from the two backgrounds. Are there ways of averting this and ensuring everyone gets quality education? There are various ways that can be used to narrow the achievement gap. They are discussed in the following section. Before addressing the problem, it is good to understand what is causing the gap increase. It is evident that the children coming from rich families are taken to the best schools which have the best facilities and they have the requirements that enhance their learning environment to ensure that they succeed or make it in education. On the contrary the children coming from the poor families hardly have the money and so they will end up in the schools offering poor education and having poor facilities. According to Reich this can be solved by harmonising the standards of education offered. The best way to address the problem is therefore to make sure that all the students get quality and same education. Robert looks at the teacher: student ratio in the schools serving the two groups and realizes that though the ratio is closely the same, the funding per student in the wealthy owned schools is very high and among the highest across the improved countries being analysed. If the government could intervene and increase the student funding then that would mean that the children from the poor families will also have an opportunity to have good facilities and boost their learning. The lack of quality facilities is a major drawback

Wages Of Sport Athletes :: essays research papers

Wages of Sport Athletes   Ã‚  Ã‚  Ã‚  Ã‚  How would you like to be paid twenty-three million dollars a year ? It is obvious to say that everyone would more than love it. This figure is only one of the many outrageous wages athletes are being paid today. True, not all twenty-three million dollars goes directly to the athlete because of Uncle Sam. Still these figures are too extreme regardless of the sport, baseball, football or basketball. The athletes here in the United States are without a doubt the greatest on earth. The only problem is so are their wages. Although the athletes pay indicates the greatness of their individual ability, the amount earned per year is way beyond reason. Due to these great wages being paid in particularly in the sport of basketball, the games greatness is being lost.   Ã‚  Ã‚  Ã‚  Ã‚  One example of the extreme pay an athlete can achieve is shown by an athlete named Michael Jordan. This basketball player is being paid thirty million dollars for the 96 - 97 season. Last year for the season of 95 - 96, Jordan was only being paid 3.5 million. While being paid this salary, Jordan hardly ever complained too much even though the amount Jordan was being paid was very low for the NBA. During this season Jordan never made any kind of statement about quitting or even leaving for another team to make the money he may deserve. Other players such as Shaq (Shaquille O'neil), and Reggie Miller, and even teammate Dennis Rodman have been known to say things like this. The only difference between Jordan and the other athletes is that Jordan seems to have a great devotion towards his team and the other players do not have the same loyalty or devotion. The circumstances appear that Jordan might actually play for the mere love of the game, while others only play for the love of money. Regardless of the motivation for playing the sport, a salary of 30 million dollars is outrageous.   Ã‚  Ã‚  Ã‚  Ã‚  If you were to break down this thirty million dollars into different categories such as how much money Jordan earns per game, the true outrageousness will appear. For instance over an eighty-two game season Jordan will be paid $365,854 a game. That is more than any middle and even most upper class people make in one year. In one single game, it is hard to believe that one man could make more than one person for a year.

Lago’s Motiveless Malignancy

S. T. Coleridge regarded Iago as â€Å"A being next to the devil, only not quite the devil whose explanatory soliloquies were ‘the motive hunting of motiveless malignity’†. From your reading so far, to what extent do you agree with this view? Iago is one of Shakespeare’s most compelling and sophisticated villain. He is considered as such because of the trust that Othello puts in him and which he betrays while maintaining his reputation of an honest and reliable man.Shakespeare presents Iago as cynical, quick witted and opportunistic, therefore having all qualities of stage villains in revenge tragedies. He is eaten up by jealousy and hatred, and this leads him to seek ways to destroy Othello by poisoning his mind against Desdemona. Iago is a master in pretending and destroying. Most of the times we see that he enjoys having an audience, because we see that he has a lot of soliloquies where he outlines his plot very clearly. However he is rather mysterious e specially when he refuses to speak at the end of the play.In fact, it is this silence that led to Coleridge concluding that he has a â€Å"motiveless malignity†. The same critic also viewed Iago as â€Å"being next to the devil†. Here Iago is no longer considered as the epitome of evil, but he is seen as an example of an emotionally limited man, driven by jealousy. Most other Shakespearean characters do bad things in order to achieve a particular goal. Often the motive is ambition as in Macbeth or revenge, as in Hamlet. The thing about Iago is that we really never know for certain why Iago acts In this way.However, many people think that the possible motive for Iago’s actions is envy, particularly towards Desdemona, Cassio and Othello. Iago sees them as more noble, generous and in the case of Cassio, more handsome than he is. This is reflected in the line when he says: â€Å"He hath a daily beauty in his life that makes me ugly†. In addition, Iago suspect s his wife, Emilia, of infidelity with Cassio. Iago’s relationship with Roderigo is driven by callous greed, and when his â€Å"purse† becomes a dangerous inconvenience, he kills him.His motives for destroying Othello’s happiness are driven by negative impulses. Iago holds a grudge against Othello for promoting Cassio instead of him. Apart from normal jealousy, Iago is also eaten uo with sexual jealousy. He hates Othello because he suspects that the general has â€Å"twixt my sheets .. done my office†. And because of this paranoia, Iago determines to use the goodness of Othello’s wife, Desdemona to â€Å"enmesh them all†. Another motive, for Iago to hate Othello is racism.His low opinion of him is very clear in many of his speeches, especially in the way that he mentions him. Iago wants to degrade those that he despises. Iago is self-contained, egotistical and confident. These qualities help him in his treacherous quest. He is also very succ essful because he is able to play several roles convincingly, and is able to adapt his style to suit any occasion. Iago only reveals his true nature in his soliloquies. And this is why it is difficult for us to see the real motive beneath the appearance that he creates to cover his true self.