Testing Results For Pharmaceutical, Para Medical And Cosmetic Products & Food Supplement

In the preceding chapters basic elements for the proper execution of analytical work such as personnel, laboratory facilities, equipment, and reagents were discussed. Before embarking upon the actual analytical work, however, one more tool for the quality assurance of the work must be dealt with: the

Many other accomplishments were made during this time. As many believed trusts used "threats, intimidation, bribery, fraud and pillage" (James Weaver) to control industries, unions and the government were able to pass Acts and create organizations to keep monopolies at bay. Progressive reform movements allowed trusts and monopolies to be disbanded and kept more from forming. Also, in the political and economic changes of this time, laws were created to produce safety standards in the food business. The Pure Food and Drug Act states that it is unlawful to sell or produce "any article of food or drug which is adulterated or misbranded, within the meaning of this Act." This was a tremendous change from the awful conditions in meat factories described

The Food and Drug Administration is the most crucial organization that is affiliated with reducing adverse drug events. Its mission as a department is to “[protect] the public health by assuring the safety, efficacy and security of human and veterinary drugs.” Under the United States Department of Health & Human Services, the FDA is also responsible to provide scientific studies and statistics to help citizens improve and maintain their health. This is achieved by carrying out surveys and influencing residency programs to be aware of these problems.The FDA also has close knit relationships with pharmaceutical companies to ensure safety and quality of drugs (David 2010). Therefore, this department has a broad regulatory authority that oversees

In order to comply with the microbiological criteria of Section "C" of the Standards, samples of finished product or pre-converted materials from the manufacturing plant must be analyzed in a U.S. laboratory certified by FDA to conduct these tests. Samples are to be submitted a minimum of eight times per year.

For the submission of the registration dossier, I prepare the quality overall summary (for Common Technical Document CTD module 2 and 3) by reviewing and collating chemical information of the constituent, chemical and microbiological QC test results, validation summary. I often prepare risk management plan when required for the TGA registration submission (Please refer to my response to SC-2 for further

Each of these tests involves two or more treatments: 1) controls to provide standards for comparisons, and 2) unknowns to be identified. The unknown solution may or may not contain the substance that the investigator is trying to detect. Only a carefully conducted experiment will reveal its contents. In contrast, controls are known solutions used to validate that the procedure is detecting what is expected and nothing more. During this laboratory, we will compare the unknown solution's response to the test procedure with the control's response to that same

Management will evaluate the significance of nonconforming work and notify clients in writing within three days of the investigative conclusion. Management will document to the client how the reported test results were affected. The laboratory Corrective Action Report will indicate the name of laboratory personnel who notified the client(s).

The principle of audit is to evaluate the processes (pre-examination-examination-post examination) and their compliance with ISO 15189, INAB guidelines and policy document and other external document as required. Audits fulfil a number of functions in this regard by ensuring compliance with laboratory policy, system and procedures and providing an effective means of corrective action for issues which may arise. The audit also provide mechanism for step-wise continuous improvement. The vertical audit was discussed in the staff meeting.

Sugar is good in moderation, however too much sugar is bad for your teeth and weight. Many foods we eat daily contain good and unhealthy sugars such as fruits, bread, vegetables, and even pasta (Coffman, n.d.).(Carbohydrates contain sugar (Coffman, n.d.). Normal white sugar doesn't contain any nutrients, however there are other sugar alternatives that are natural sugars and artificial sugars which are established in laboratories (Coffman, n.d.). We often hear or see sugar replacer on television commercials or many eating establishments, have you ever wondered if they are really good for you? Below are a few examples of Natural Sugars and Artificial Sweeteners (Coffman, n.d.).

The use of this new type of medicine first sparked a frenzy in the mid-19th century. A competition began between conventional and CAM medical providers, however, in the mid-20th century with the increasing importance of scientific evidence and experimentation, the popularity of complementary and alternative medicine began to decline.

Carbohydrates are the product that made up from carbon, hydrogen and oxygen. Carbohydrates are form by the combination of carbon dioxide and water molecules. The carbohydrates contain two specific functional group in it which is the hydroxyl groups and carbonyl groups.A reducing sugar is a type of sugar with is an aldehyde group.This means that sugar can act as a reducing agent.The procces of reducing sugar is isomerisation,example of reducing sugar islactose,maltose,glucose and fructose.All monosaccharides are capable of reducing other chemicals such as copper (II) sulphate to copper oxide.Beside that disaccharides such as maltose and lactose are reducing sugar,however sucrose is non reducing

The laboratory will utilize a variety of quality control sample types as shown in Table 3. Matrix spikes and matrix spikes duplicates will be performed on field samples that are provided with sufficient volume (generally three times original sample volume). All other blanks, duplicates and control samples will originate in the laboratory and be performed to ensure accuracy of the analytical method, equipment and procedures. These

Dan Nanigian, President and CEO, is essentially the Management Representative and has the ultimate responsibility to maintain the Quality Management System and also is required to guarantee that the system undergoes continual improvement, is efficient, and complies with Mil Std-Q-9858A requirements. His job is to work with the General Manager to initiate and oversee the Quality System and provide the necessary resources to uphold the system. The two make up the Executive Management Team and are also required to conduct management reviews of the Quality System, along with overseeing the goals established to reduce the amount of rejects produced in each phase of operations and in the company 's products (pg.2). The Quality Management and System Standard is reviewed at least once per year to "assess the effectiveness and continuing suitability of the standard" (pg.4). Nanigian is solely responsible for carrying out such reviews being sure to document the conclusions accordingly.

A contract manufacturing company has been analysing a tablet product by the method described in the British Pharmacopoeia (BP) monograph. This is the method detailed on the product License and BP methods are generally considered to be validated. After trend analysis for the annual Product Quality Review (PQR) report, it has been discovered that 5 batches were rejected in 2013 due to high out of specification assay results. Furthermore, several batches had assay values close to the upper specification limit. The release specification limits for the product are 95-105%.

Today it is important for all food diagnostic laboratories and research facilities to implement and make accurate quality of analysis as per the reach, volume and kind of the work performed. The essential go for any expository food testing or analytical laboratory ought to be to guarantee that their scientific results are of accurate quality concerning their accuracy and trueness. This relies on upon whether lab is mean to apply for technical competence. The lab 's support in proficiency testing activities is the prerequisite of appropriate accreditation. The reason for this necessity is to delivered diagnostic result exact and repeatable by laboratories. Proper capability testing information can be utilized to uncover a laboratory facility 's ability to potential clients, customers, accreditation bodies and other outer substances. Contribution in the proficiency testing additionally gives exceptionally valuable feedback in the inner checking of a lab 's quality framework. This proficiency testing activities helps a lab to confirm its competence to perform particular tests and calibration.