Richard L. Friedman’s main argument in “Aseptic Processing Contamination Case Studies and the Pharmaceutical Quality System” is: The author concludes that the sterile dosage form contamination issues can emerge in the deficient design concepts and the daily operations of the pharmaceutical industry determine safety and efficacy of drug products by analysis of 8 case studies. In this paper, the following system deficiencies are mentioned: production system, packaging and labeling system, facilities and equipment system, material system, and lab control. What I learnt from this paper is the importance of supplier audit, rational design of validation method and facilities design.
Firstly, supplier audit is important. Although the author
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The good quality of the vendor’s product can also help the customer to guarantee their finished product quality.
Secondly, the rational design of validation method is very important. In the case study 1 “Aseptic Processing of a Sterile Active Pharmaceutical Ingredient (API)”, the process simulation (i.e., media fill) program was not adequately representative of the actual manufacturing process. The process simulation validation program is used to detect and diagnose an existing source of contamination. However, some companies do not realize this usage, and the process simulation validation program designed does not reflect the actual situation of production. Not just only for the simulation validation, other validations, like analysis methodology validation, equipment performance qualification, also exist this kind of problem, that is, the method used to validate/qualify does not have a sufficient sensibility and representativeness. Many engineers do not know how to design the validation method; even they do not like to perform the validation, but FDA mandates to perform validation, so some of engineers copy with it just for FDA inspection, not for keeping the quality of production. It is clear to cause the waste of manpower, material and financial resources. Good validation design cannot only help to maintain a robust quality
While it is our main goal to be fast, accurate, and friendly we also want to make sure that the quality is there with our products as this will build repeat business for our restaurant.
Today’s consumers are constantly trying to judge the quality of products. But what is quality? How and by whom is quality determined? Some would say the designer creates specifications, which in turn dictate the quality of a product. That quality is also based on the acceptable value of a part within a whole product.
Prior to 1978 the pharmaceutical manufacturing was highly regulated, drug product quality and sterility testing was based solely on finished product testing i.e. it 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
If we were to lay the topic “effects of globalization” on the table, what assumptions might arise? Well, one might point out whether globalization can be considered as a positive thing or negative thing towards different cultures. The article “Case for contamination” gives insight on the author’s views and arguments towards globalization and how that intertwined with the people in Ghana.
Due to running our own manufacturing plant we are able to implement more strict quality standards. One of every ten products will be thoroughly inspected and one in every 1,000 will be real life tested to ensure that each batch comes out with equally great quality. Western Kicks upper management will also have annual meetings with suppliers to discuss quality expectations. Those meetings can happen more often if necessary and all supplies will be inspected before being used for a batch. If more than 1 in every 50 of an item have to be discarded or returned due to quality problems, a meeting must be held with the supplier as soon as business allows.
To have an impressive manufacturing criteria that will be met for proper uses of items which need to be bought through online internet and there is manufacturing that has become part of the industry that will benefit you as you won’t have to worry about consistent requirements you will have to consider as you look for items that get sold on this online store for your use and consistently provides you with items you as a consumer will want to insist on using.
In order to make sales and have a successful running company you need to know how to market your products and or ideas to the group of people for whom it is intended. The quality of your product must also be top tier because marketing is only half of the battle. Before hearing Tripp Transou talk I was unsure about how important the quality of the product was. I was under the impression that marketing was number one because that what got people to buy it. However, he allows me to realize that if you want consumers to buy your product more than just once then you must ensure that the quality and consistency of your product is perfect. There must also be attention to detail in every aspect of your company from making sure the facilities are kept clean to the product being properly manufactured, stored, shipped and tested. This attention to detail will translate into more sales and having a more successful and efficiently run company than those who do not seem to care for their consumers. Tripp’s talk allowed me to see how much goes into running a successful business whether it is big or small. His journey of how he came to be the successful businessman he is today inspired me to never always have an open mind and never turn
We respect our customers and hence we struggle to only offer quality products. All the products that we sell are going through a rigorous inspection that is conducted by our suppliers, prior to being introduced for sale on the market.
customers looking for saving manufacuring costs and by not reducing the quality. Dominite can add value to customers
Good manufacturing practices and compliance to regulatory requirements with right first time can make a significant difference in helping pharmacists compound medications safely, accurately and efficiently. Any unexpected errors that happen during the compounding medication may cause potential impact to the life of patients. It is important to collect the data of past history of errors surfaced during the past and analyze the data to continuously improve the processes to preventing errors to improve the medication and patient safety in the compounding medication.
As a quality improvement professional, I was presented with a Peer Review Quality Improvement Project to critically evaluate the structure and elements within the project. The purpose of this paper will describe the results of the critique ratings and methods used to evaluate the Quality Improvement Project. Subsequently, it will make recommendations and provide constructive feedback to improve the effectiveness of the Quality Improvement Project to improve the quality performance problems related to medication errors.
All material are subjected to receiving inspection at the time of receiving by an authorized employee. All damage or visually contaminated materials will rejected at the time of receiving and returned to the vendor.
A recent FDA regulators report is saying that Johnson & Johnson “still hasn't solved all the problems at the Pennsylvania plant largely responsible for a huge recall of children's medicine earlier this year.” Plant operations have been suspended as Johnson & Johnson performed in depth review of its manufacturing processes. However, finance reports from FDA investigators on recent inspection conducted in the plans have revealed again problems on manufacture control. The main failures are in establishing control procedures that monitor the output and validate the performance of the manufacturing processes. There is failure to thoroughly review any impenetrable discrepancy and failure of a batch or any of its components. Another major problem is lack of record keeping allowing data to be reviewed at least annually to evaluate the quality
Quality assurance collectively influence the quality of a product. The product need to be designed and developed, considering GMP and GLP (Good laboratory practice). The system ensured that there is a procedure regularly for self-inspection and auditing.