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.

Populism DBQ

In the late nineteenth century, around 1880-1900, many farmers were experiencing problems and threats to their way of life. The valid complaints of the farmers dealt with the money supply system in America and the large railroad companies. In 1892, the platform for the Populist Party was laid down. In this platform it is stated that â€Å"the national power to create money is appropriated to enrich bondholders †¦ thereby adding millions to the burdens of the people.†This is discussing the demonetization of silver and the negative effect it has on the common people, such as farmers. Later on in the platform is it also discussed that silver has had widespread acceptance as a coin for a very long time and by demonetizing it to increase the purchasing power of gold, the results are several negative consequences which will eventually lead to â€Å"terrible convulsions, the destruction of civilization, or the establishment of an absolute despotism.†This unhappiness of fa rmers regarding the money system in the United States is also shown in a political cartoon from The Farmers Voice, a Chicago newspaper in the late 1880's or early 1890's. The cartoon entitled â€Å"The Eastern Master and His Western Slaves† depicts farmers as slaves to the wealthy eastern businessmen. It is representing the exploitation of the farmers and shows yet another of their economic struggles; the mortgages they bore on their farms.Further evidence that supports and validates the farmers' complaints about the current economic situation is found in William McKinley's acceptance speech given in Canton, Ohio on August 26, 1896. In his speech, McKinley said that even though free silver â€Å"would not make farming less laborious and more profitable.. † farmers and laborers are the ones who suffer the greatest as a result of the cheap money. â€Å"They are the first to feel its bad effects and the last to recover from them†¦ †. The belief that silver is the solution of the problems for farmers is opposed in J.Laurence Laughlin's â€Å"Causes of Agricultural Unrest† article in the November, 1896 issue of Atlicantic Monthly. Laughlin describes that the increase in supply without an increase of demand led farmers to believe that silver can solve their issues by his saying, â€Å"the sudden enlargement of the supply without any corresponding increase of demand produced that alarming fall in the price of wheat which has been made the farmer's excuse for thinking that silver is the magic panacea for all his ills†¦Ã¢â‚¬ He then goes on to describe that farmers have simply pushed the blame on the scarcity of gold as opposed to realizing the actual cause is their own overproduction of wheat. The effects of the different acts and laws regarding money supply is shown in the United States government data from 1961 depicting the population of the country along side the money in circulation from the year 1865 through 1895. This dat a shows that from 1865 through 1885, the population was increasing, however the amount of money in circulation was decreasing rapidly.This suggests that the effects of the acts and laws regarding money were resulting in the deflation of of the currency. against the railroad companies is credible because during this time period the government showed enormous favoritism towards large businesses even though the railroads were monopolies. Further discontent with monopolies is expressed in A Call to Action: An Interpretation of the Great Uprising. Its Source and Causes by James B.Weaver, a Populist candidate for president in the election of 1892. Weaver described that trusts and monopolies use â€Å"threats, intimidation, bribery, fraud, wreck, and pillage† to â€Å"impoverish the producer, drive him to a single market, reduce the price of every class of labor connected with the trade, throw out of employment large numbers of people †¦ , and finally †¦ they increase the price to the consumer†¦ †.The farmers and laborers of the late nineteenth century faced two main problems; money supply and large businesses such as railroads. These issues resulted in a variety of complaints from the agriculturists, however the grievances did prove to be valid based on the evidence previously presented. The farmers were struggling to survive off of the small profit they received, and they suffered even further when large monopolies and railroad companies took actions that dwindled their profits further.

Problems Related to Internet Addiction on Children Essay

Internet could be considered as one of the best useful technological invention of our time. One can find every kind of information which s/he looks for on the internet. Because it is very useful, it is used by almost everybody especially by young people. Sometimes using internet too much may cause a serious problem named â€Å"internet addiction†, which affects mostly children. Internet addiction is a serious problem affecting especially children in two possible ways. Firstly addiction to internet influences children negatively regarding their socialisation. Children are affected by internet addiction because it takes too much time. For example, children who spend too much time with computer can not spend enough time with their family. They can not have fun enough with their family. So they evaluate a weak relationship with their family. In addition, spending too much time with computer instead of reading books may cause a weak talking skill. Moreover, not playing classical children games might affect children’s socialisation. Children who spend time with computer instead of playing classical children games with their friends because of internet addiction will probably have weak social relationships in future. Having good childhood friends is vital for having a good adulthood social life. Also, they can not learn how to struggle with real people outside because of lack of playing classical children games. It may cause being unsuccessful in their work life in future. Secondly, using too much internet might contribute to psychological problems in children. Overuse may cause increasing desire to use internet related to insufficient joy. Children addicted to internet can not get the same joy with their first internet using. The jot decreases day by day. They increase their daily internet using time in order to reach the same joy with the joy which they get previous day. Overuse may also cause being aggressive and anxious when being kept away from internet for a long time. These symptoms may even turn into symptoms of depression. Furthermore, children addicted to internet could become not to able to differentiate real life from online life. They may be extremely happy when they reach a higher level in an online game. They do not care about as much as they care about online games. They also identify themselves with virtual characters in online games. To sum up, internet addiction may cause two possible problems on which are related to their socialisation and psychology. Children should be protected from internet addiction in order to be raised as a healthy generation. Parents should make their children attend real activities (such as scouting). They also should limit their children’s internet using time.

The Greatest Inventions in Chinese History