Prevention of cross contamination: Contamination is the presence of undesired materials on a surface or fluid, here are some examples of sources of contamination; people, raw materials, air, and water. These should be prevented from occurring as it as a high risk safety effect on patients and it should be considered from design stage. This can be prevented from occurring by implementing, monitoring and following rules which are;
- SOP must be followed at all times.
- Any changes to the SOP must be documented and recorded (GDP).
- SOP must be detailed (should have equipment name and number, type, date approved, revision number, change history if any, process and operation steps, name, etc)
- PPE must be worn at all times.
- No eating or drinking in the production area.
- Only trained and competent personnel should operate on equipment.
- Equipment must be labelled and identified correctly.
- Raw materials must be inspected and testing before and after use.
- Tests must be carried out at each process stages, so as to safe guide cross contamination. If this do happen, it will be easily identified at that stage, when, where and what might have gone wrong.
- After production, equipment must be cleaned properly and tested for cross contamination (GMP).
- Air going in and out of production should be controlled by using filters e.g. HEPA.
- Final product must be tested, to ensure that there are no contaminations in the product.
- Packaging and labelling must be done correctly.
Validation: Is the documented act of demonstrating that an activity will consistently lead to the expected results while meeting regulatory requirements. It requires a minimum of 3 batches to run simultaneously with an error. If an error occurs ...
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Why Validation Matters: A Brief Guide to a Critical Aspect of the Pharmaceutical Manufacturing Lifecycle
June 3, 2013
Barry Peters and Heather D. Ferrence | Telerx (opened at 13/04/2014 @ 14pm) (http://www.pharmacompliancemonitor.com/why-validation-matters-a-brief-guide-to-a-critical-aspect-of-the-pharmaceutical-manufacturing-lifecycle/4983/)
Validation of Pharmaceutical Packaging Lines Afshin Hosseiny, Ph.D. Tabriz Consulting Limited
http://www.commissioningagents.com/clientuploads/directory/Documents/Integrating%20C&Q%20ISPE%20GL%20newsletter.pdf
http://apps.who.int/medicinedocs/en/d/Jh1792e/20.5.2.html#Jh1792e.20.5.2
http://apps.who.int/medicinedocs/en/d/Jh1792e/20.7.2.html
References
Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Pharmaceutical Excipients. WHO Technical Report Series, No. 885, 1999, Annex 5
How am I going to make it a fair test I will use a clean flask for
Nucleon is a small biotechnology start-up with a very promising potential product (CRP-1), which is also the first product that Nucleon is planning to go into the clinic market. Nucleon has reached to human clinical trials phase with its product and it has no manufacturing facilities that satisfy the guidelines for these clinical trials and testing. Nucleon is on the verge of making a critical choice of manufacturing strategy, which will affect Nucleon’s survival in the intense competition in the long haul. Nucleon management is aware of the facts that they have a limited budget to start with, the financial environment in biotechnology is rapidly changing and establishing the safety and efficacy of products like CRP-1 is complex, time-consuming and expensive; that’s why they want to evaluate risks and rewards of each manufacturing strategy before making their final decision.
...e are now regulations in place dealing with casings and other equipment (Regulations). If there were more regulations like this, there might be less breaks and les contamination. There might also be less spills or related accidents if there were more regulations on the disposing of these dangerous chemicals. How the chemicals are being disposed of should be monitored (Howells).
Pharmacies in France are specialized facilities which work closely with clients, ensuring safe products and providing professional advice. Pharmaceutic...
To make sure it is a fair test; the procedure is repeated a couple of
Pharmacy is a booming field when it comes to medicine, but it certainly has controversial issues such as compounding drugs. While the practice of making drugs customized to a patient seems ethical, there are problems that come along with it. Drug compounding was the norm in the past, but over time consumers began to see issues with it. Drug compounding still occurs to this day because some patients do need medicine specifically tailored to their needs. Compounding has also been the focus of recent disasters, some of which occurred less than two years ago. Whatever side one may take on this issue, it is clear that compounding medicine will be a polarizing issue for years to come.
A lot of things can happen in between those tests, such as a contractor using lead paint and it not being caught. The professor had generous budget and access to all of the records, with this, I think that Mattel should have run the tests more frequently. After all, the lives that are stake are those of millions of children around the world. And do not forget about all of the stakeholders and shareholders when they have to make a recall. You might even lose the trust of your loyal customers, which will hurt the company in the long
Share planned independent requirements of final product with CMOs and monitor the accuracy of dependent requirements of drug substance at CMO
Every part can be experimentally approved by running examinations that exhibit and test your vision. With acceptance, entrepreneurs will have the capacity to distinguish and address the key dangers in your item or administration and make changes in accordance with legitimately position their image.
Lieberman, Herbert A, Lachman, Leon (2009), Industrial pharmacy: Pharmaceutical dosage form-milling. Banglore, Pune. ISBN: 978-81-239-1679-8.
Each waste stream shall be treated as a potential health hazard. Excessive exposure to these waste streams must be reduced to the lowest possible level by using appropriate
Testing must be performed on a pre-established schedule and will be executed under supervision of the qualified individual to validate the sampling; besides, must be implemented by third party testing services, and the Instruments used for analysis should be calibrated in accordance with established procedures.
The only way to ensure that sterilization has occurred is to use the biological monitoring methods. This is because these are the only tests done which show whether or not actual microbial life has been killed. Biological methods are the only ones which are recommended by the CDC (Centers for Disease Control and Prevention), the AAMI (Association for the Advancement of Medical Instrumentation), the AMA (American Medical Association), OSHA, and OSAP (Office Safety and Asepsis Procedures Foundation)
pollutant before materials are used, removed the pollutant after it is formed, or altered the
Where used cleaning cloths, pot scrubs etc. shall be cleaned and sanitised or they shall be disposed of after use in order to ensure that they are not a source of contamination. (Unsure)