EHS Standards Evaluation

EHS Standards Evaluation EH S Evaluation: The product should be evaluated with respect to environmental health and safety, such as handling instructions, personal protective equipment’s and deactivating agents should be determined and made available to every personnel who are making contact with the product. Depending on nature of product, the studies are performed to validate the deactivating agents and procedures. Although it poses additional cost and timing to technology transfer, but it is the first line risk assessment for technology transfer with intending of protecting those who will be producing the product. However during technology transfer the EHS system should be maintain standards across the company. The EHS standards to be maintained for the technology transfer are as follows: Management  Systems Standards These Standards provide the framework for EHS risk management, incorporating many key elements to successful EHS management such as regulatory compliance, risk assessment, communication, self-audit, and senior leadership engagement. Risk topic standards This group of documents sets expectations for management and control of many important EHS programs including workplace safety, occupational hygiene, fire and life safety, and environmental impact reduction. Program standards These standards address the key program areas , such as office safety, contractor safety, EHS risks from suppliers of material and services Raw material specifications: The raw material may seem like basic element in the manufacturing process but it can often provide most difficulty and unforeseen delays during technology transfer. Within the pharmaceutical industry there is a great emphasis on designing quality into a product by monitoring and controlling what is delivered for manufacture of the product meets the requirements for what is needed for manufacture of the product. However the material standards should meet according to their relevant regulatory bodies, but not to be excessive because this leads to the cost and potentially cause delays for technology transfer while waiting for superfluous testing results. Analytical Method Transfers Transfer of analytical methods should accommodate all the analytical testing required to demonstrate compliance of the product to be transferred with the registered specification Analytical methods used to test pharmaceutical products, starting materials, packaging components and cleaning (residue) samples, if applicable, should be implemented at the testing laboratory before testing of samples for process validation studies is performed A protocol defining the steps should be prepared for transfer of analytical methods. The analytical methods transfer protocol should include a description of the objective, scope and responsibilities of the specification of materials and methods; the experimental design and acceptance criteria; documentation (including information to be supplied with the results, and report forms to be used, if any); procedure for the handling of deviations; references; signed approval; and details of reference samples (starting materials, intermediates and finished products) Avoid pit balls during Analytical method transfer: The exchange of the relevant method information and subsequent compilation of the transfer protocol avoid a lot of foreseeable problems during method transfers. Nevertheless potential mistakes should be reviewed. These include 1) The calculation of the results. Calibration standards and correction factors Rounding Integration parameters(eg: minimum area, threshold, noise) Reporting imits, summation or averaging procedures 2) Availability of reagents, samples, and standard material. 3) correct shipment and storage. 4) Equivalent equipment Qualification, procedure and acceptance criteria Materials and carry over properties Temperature ranges Equipments: Equipment’s are a critical part of the transfer process. For technology transfer, technical information of products as well as those of manufacturing equipments are important. To establish equipments conforming to GMP, it is essential to obtain and understand information from RD process so that quality assurance of subject drugs can be secured and the equipments can comply with required conditions for manufacturing. For that purpose, the following technical information should be transferred. The RD department should clarify considerations of GMP compliance specific to subject drugs and manufacturing methods (manufacturing processes), and present them to a facility and equipment department. The facility and equipment department should establish facilities and equipments reflecting the above considerations, clearly details of the establishment and operational considerations of those facilities and equipments, and present them to a drug manufacturing department. The drug manufacturing department should fully understand the above information, implement validations, perform appropriate operations and controls in conformity to the established facilities and equipments, and records results of operations and controls. All systems need to be ready before validation batches can be produced. Systems checklist, agreement on acceptance criteria and commercialization, stability plan, agreement on annual revalidation and approval of the transfer report must be complete to move to the Process Validation. A systems checklist with quality assurance approval provides necessary documentation that was gathered in the transfer. This should include vendor audits, cleaning validation (residual solvents), Melamine requirements addressed, equipment qualification completed with operational ranges. BSE/TSE addressed, specifications and SOPs approved. Once raw materials and packaging components are released, the transfer final report is approved. With batch records approved, risk analysis complete, and stability protocol approved, Trackwise systems are set up. Documented evidence of all required systems is placed in a file. This file is then reviewed by QA prior to signature of the Validation protocol. The decision to commercialize validation batches is made by senior leadership based on a modified risk assessment. Included in the commercialization risk assessment are a review of the product trending report, a review of the process gap assessment and discussions with regulatory. The commercialization strategy also needs to meet the January 2011 FDA guidance for product commercialization. The stability protocol includes stability requirements for each of the countries the product will be marketed. This may require rental of stability chambers or space in stability chambers for years as the diverse stability requirements are reviewed. The stability protocol may also include expectations for product stability results in relation to commercialization. Looking ahead, planning needs to include agreement on annual revalidation and filing activities. Execution of the validation plan needs to follow the agreed plan. Typically a daily update meeting will be held to provide updates from the previous days activities and ensure all systems are a go for the daily activities. The validation team needs to act accordingly when issues occur. All deviations from the plan must be clearly identified and tracked for root cause analysis. System controls are intended to cover normal operations, external events need to be handled with facility policies and be included in the validation final report. Documentation Hundreds of GMPdocuments are required for process transfers. The Code of Federal Regulations provides a listing of expected documentation including: raw material and component documentation logbooks batch records laboratory records distribution records A complete list can be developed utilizing the process maps (see Gate 4) and standard documentation sets.Once the list is made, divide the documents into groups.Remember raw materials documents will probably be required first, but finished product testing protocols often require finished goods test procedures to be validated prior to accepting the product. The project schedule should provide insight into when documents will be required. The quickest way to complete the transfer is to reformat records from the sending site, but this practice often leads to non-conformances and issues because there is a lack of understanding content and history. Each document needs to be built with the foundation process map identified in Gate 4 and utilizing Subject Matter Experts (SME) identified as part ofGate 2.The control of the critical process parameters (CPP) must be understood and the control strategy needs to be included in the documentation to ensure product attributes are achieved. Agreement on terminology and format with quality and regulatory units helps ensure standardized documentation, which allows employees to follow repeatable processes.Each document should have a dry run with personnel who have not been exposed to the process, the related SME and a documentation author (if necessary).Pictures often help, but authors need to be mindful of what is in the background. For example, I once had a formulation tank CIPprocedure written with pictures taken in the tank manufacturers parking lot. Finally a document review team is formed with appropriate representation to ensure content is consistent with expectations.Often document reviewers lack the process understanding to assess technical details but can provide oversight for other requirements.The documentation tracking sheet should monitor status and escalation needs to occur if a maximum of two revision cycles is not achieved.

Ballroom Dancing :: essays research papers

Have you did something that you didn’t really want to do, and then later get selected for doing it? Well, I have. It was another beautiful Friday at Spottsville Elementary School, and ever Friday at Spottsville was music class. But today we didn’t have music class, today was something totally different. Our music teacher Ms.Belcher was having try-outs for Mrs. Benson's ballroom dance team. To tell you the truth, I was just going to get up there and goof-off, and that I did do. But, on that Friday something went wrong, something terrible, something I didn't expect to happen. "Now class take your seat. Today we will be trying out for ballroom dancing. Only the best dancers will be teaching the 5th graders for Mrs. Benson," said Ms. Belcher. Well, I thought that it was going to be boring (which it was), and I was mad because we all had to try-out (which we all did). Ms. Belcher picked the first group and then walked over to her boom-box and started playing the Macarena. This was simple; everyone knew how to do that dance. About ten min. into dancing, my friends thought it would be funny for someone not to know how to do the Macarena, and just do something totally different. So they dared me to, and like the comedian that I am, I agreed. When she called up for the last group (which I was in) everyone was laughing, including me. I did do something totally different from the Macarena, I did the disco. Even I can’t believe it now, but I was. If I was in the audience and could see myself dancing, it would have probably looked like something off the movie â€Å"Boogie Nights†, starring John Travolta. And I know I would have been laughing too. Finally Ms. Belcher turned off the music and said, "Now class settle down. I will have the results for you sometime next week." At the end of class when we all leaving everyone was telling me how funny it was, but you could tell that Ms. Belcher did find it amusing at all. But I don’t care, as long as I got a few laughs (well it was more than a few). That following week I was sitting in Mr. Adkin's class, my regular teacher. He was showing us how to fractions, when someone knocked on the door. Mr. Adkins walked over and gladly opened it. Mrs. Benson stepped in the room and told us why she had came. Then one bye one she called people out into the hallway.

Advantages and Disadvantages of Indian Population

Free sample essay on Population Problem in India. The population problem is one of the burning issues being faced by the country. It surmounts all the problems of the country. The rapid population growth is often referred to as population explosion. The population of India has risen dramatically during the post-independence period. The increase in population is due to the spread of health care facilities thus resulting in the fall of death rate. Within a period of a little over half century, population of India has tripled to cross one billion marks.It is predicted to surpass China by 2030 to become the highly populated country in the world. The unprecedented population growth has contributed too many problems such as poverty, unemployment, food problem, housing, clothing which are the basic necessities of life. These things are directly related to the quality of life. The rising population has outpaced all the development and technological gains. It has nullified all our achievement s in the field of industrialisation. Despite all the progress made even one-fourth of India’s population is still living below poverty line.Even they do not have the bare necessities of life available to them. Millions of people have to go to bed without food. Starvation death is frequent in India despite being self-reliant in food production. Population growth is witnessing geometrical progression. The resources of subsistence are increasing in arithmetical progression. India has to accommodate sixteen per cent of total world population in 2. 3 per cent of total land. The pace of our population growth is horrifying. Forty-four children take birth every minute.Our population is rising by 2. 9 per cent per year. Thus every year an extra 26 million people are added to the existing population. Availability of better food, better hygiene and above all modern facilities in medicines, surgery and health care have caused longevity and decline in the rate of mortality. It has further aggravated our population problem. The government is taking stern measures to check the Population. It has started the family planning as early as immediately after the independence. It was the first country to introduce family planning.But the programme failed to bring desired result. So it is the need of the hour to realise the menace of population growth. Our society needs to be made aware of its dangers. The NGOs and media should come forward to create awareness in terms of population growth. We as aware citizens should change our mindset. Failure to check further increase in population may have disastrous effects. A mass awareness programme should be launched through radio, TV and other press media. The masses should be properly educated to the advantages of family planning.

Modernist Art in Europe essays

Modernist Art in Europe essays Modernist Art in Europe 1910-25 by Robert l. Herbert Herberts thesis of his essay is to investigate the arrival of the machine and modern art and its complexities. During WWI, modernist painting and sculpture paid major attention to machinery, science and industry. Modern art during that time has become a central factor in our culture due to its dominance in public art, museums, media and literature. Herbert brings in background information and stated the avant-garde of Pisarro, van Gogh, Monet, Renoir, etc. The industrial revolution had a stronger grip on society during the 19th century, and during this time, modern art was associated with primitive nature. During the rise of industrial art their was a rise of landscapes and paintings of rural everyday life. Also, the new technique and style which became the handcraft to modern art was so avant-garde from the academic art. Modern art was involved with cubism, futurism and vorticism. He explains that all of these arts consisted of the importance of handcraft, creativity, individuali ty, and original expression. Herbert keeps bringing in the fact the machine was the leading sign of modernity. There was no more of a gap between handwork and the machine. Also, that the machine became so important in modern art because it was now a part of daily urban life, due to subways, telephones, automobiles, sewing machines, bicycles, televisions, cinema, and more advanced photographic and advertising developments. Herbert states that although the machine became a large factor in art that it was not incorporated in the work of all modernists, such as Picasso and Braque. The author then describes the modern art in epic cubism, and how it focused on geometric architecture and structures of mechanical parts with organic rhythm of daily life. And how Italian futurism dealt with modern city life, but with more immediacy, more implied movement. It was similar to cubist but with more calc ...

buy custom Sexual Orientation essay

buy custom Sexual Orientation essay Gender determines the type of jobs one is able to get and work on females are the grade school teachers as opposed to male principals in high schools in fact some states dont allow males to teach grades lower than the sixth grade (such a nationality favors males). Female doctors are so few with some states having even less than five gynecologists and in the military they add up to 2 percent these being mainly nurses (Richards, 2000). This makes females to be of a lower financial class as compared to males. Females also are not at free will to choose whether to become lesbians, as they will not be recognized. Both Amy Richards and Lisa Weiner-Mahfuz bring multiple identities forth and they consider identities such as class, race, skin color, sex orientation, nationality among others. According to Richards, the young women and girls have restrictions in their activities. For example, they cannot play soccer or form teams. Besides, having sex determines their chances of getting stable future partners. It is also evident that females cannot get most services without male escorts signatures from their husbands; they are denied bar or restraint services or important operations on their bodies without their consent. Generally, sexism is a form of discrimination due to sex. However, in the case of these authors, this is different. For instance, Lisa shows that class, race, religion (anti-Semitism) and sex orientation (lesbianism) all affect sexism. This author strongly brings out the confusion amongst mixed-class, mixed-religion, mixed-race people can undergo especially when the character could not know where to be classified between the white (she has a white complexion) and the colored. Often confusion is mixed with anger and a feeling of rejection. Feminism is encouraged by the author as a form of dealing with racism and general oppression. Buy custom Sexual Orientation essay

Hinduism Essay Example | Topics and Well Written Essays - 500 words - 2

Hinduism - Essay Example The paper will discuss the religious beliefs that are practiced by Hindus as well as their dialogue. Beliefs and dialogue One of the fundamental beliefs among the Hindu community that distinguishes it from other religion is its definition of the â€Å"meaning or purpose of life† (Oppenheimer, p. 1). While other religions’ primary objective focuses on allegiance to a supernatural power, Hinduism’s definition the purpose of life balances allegiance to the supreme authority and the need to fulfill bodily desires. Depending on a person’s level in life, the religion defines different goals to be pursued at every stage. The purposes of life at respective stages as defined under the religion include the need to achieve an individual’s purpose. As a result, the Hindus believe that every individual exists for a particular purpose and that purpose should be fulfilled in the person’s present life, before death. The religion also believes that every indi vidual has a defined level of personal success that should be pursued and achieved. Similarly, every Hindu is entitled to fulfill personal desires that include â€Å"enjoyment, sexual and other desires† (Oppenheimer, p. 1). The religion’s definition of life further provides for personal intellect among its believers. These beliefs distinguish Hinduism religion from other religions that puts emphasis on the supreme power rather than on the believers.

Emerging Trends Case Study Essay Example | Topics and Well Written Essays - 250 words

Emerging Trends Case Study - Essay Example Technical courses require creative thinking in science subjects which is the main obstacle to success to most students. Fear for science subjects has highly contributed to this problem to many candidates. Constant rise of trade schools all over America for students who are not good enough to join colleges for further studies has contributed a lot for shortage in vehicle assembly industries. The rise of trade school makes most of the students not to have vision of being a technician in future. They therefore, end their dreams in businesses (Prosser, 2009). However, most of the technicians industries are managed by aged people creating no room for the young people. The need of strong learning background in to qualify to be an automotive technician has created fear to students. Increase in wages to the workers working in industries may solve this crisis but to some extent. (U.S. Atomic Energy Commission, Oak Ridge Associated Universities.,& Southern Interstate Nuclear Board. 2014)Due to increase wage, majority of students will have an aim of meeting the demands of qualifying to be a technician due to better pay due to demand for money to most youths. However, most of the students have developed fear of doing science subjects completely. In summary, there is a need for the government to ensure that every institution is entitled to offer a compulsory science subjects to students to foster the level of awareness to science related courses. U.S. Atomic Energy Commission., Oak Ridge Associated Universities., & Southern Interstate Nuclear Board. (2014).  Nuclear related technician demand and supply: Southern Interstate Nuclear Board Region, 2013. Washington?: publisher not