Good Manufacturing Practice or GMP (also referred to as ‘cGMP’ or ‘current Good Manufacturing Practice’) is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products.
Since sampling products will statistically only ensure that the samples themselves (and perhaps the areas adjacent to where the samples were taken) are suitable for use, and end-point testing relies on sampling, GMP takes the holistic approach of regulating the manufacturing and laboratory testing environment itself. An extremely important part of GMP is documentation of every aspect of the process, activities, and operations involved with drug and medical device manufacture. If the documentation showing how the product was made and tested (which enables traceability and, in the event of future problems, recall from the market) is not correct and in order, then the product does not meet the required specification and is considered contaminated (adulterated in the US). Additionally, GMP requires that all manufacturing and testing equipment has been qualified as suitable for use, and that all operational methodologies and procedures (such as manufacturing, cleaning, and analytical testing) utilized in the drug manufacturing process have been validated (according to predetermined specifications), to demonstrate that they can perform their purported function(s).
In the US, the phrase “current good manufacturing practice” appears in 501(B) of the 1938 Food, Drug, and Cosmetic Act (21USC351). US courts may theoretically hold that a drug product is adulterated even if there is no specific regulatory requirement that was violated as long as the process was not performed according to industry standards.
The workflow can be simplified as follows:
READ MORE - Good Manufacturing Practice or GMP
Since sampling products will statistically only ensure that the samples themselves (and perhaps the areas adjacent to where the samples were taken) are suitable for use, and end-point testing relies on sampling, GMP takes the holistic approach of regulating the manufacturing and laboratory testing environment itself. An extremely important part of GMP is documentation of every aspect of the process, activities, and operations involved with drug and medical device manufacture. If the documentation showing how the product was made and tested (which enables traceability and, in the event of future problems, recall from the market) is not correct and in order, then the product does not meet the required specification and is considered contaminated (adulterated in the US). Additionally, GMP requires that all manufacturing and testing equipment has been qualified as suitable for use, and that all operational methodologies and procedures (such as manufacturing, cleaning, and analytical testing) utilized in the drug manufacturing process have been validated (according to predetermined specifications), to demonstrate that they can perform their purported function(s).
In the US, the phrase “current good manufacturing practice” appears in 501(B) of the 1938 Food, Drug, and Cosmetic Act (21USC351). US courts may theoretically hold that a drug product is adulterated even if there is no specific regulatory requirement that was violated as long as the process was not performed according to industry standards.
The workflow can be simplified as follows:
GMP requires that all manufacturing and testing equipment has been qualified as suitable for usethat I try to offer some of the collections of several tools in use for testing are:
- in use for testing and making its suppositoria
- as well as our other collections, from the balance weight
DENSITO,dissolution tester,HPLC,MB,MD+UNIVERSAL GEAR,NANOMAT,ROTAVAPOUR
or you are interested in our collection is this?
you are interested or need an explanation? please contact us
Category:
GMP,
pharmaceutical,
products,
technology
12 Comments
Medication is an important component in most of the health effort. And with the increasing needs of the service mike caron demanded that health services can provide information on health and the quality, fast and professional.
In line with this, drugs that required information can be used as a reference of quality and can be accessed quickly without spending a lot of time.
Software "INDO" will meet the needs of more than 4000 drug information circulating in Indonesia based on the brochure and insert from the manufacturer, include: Name and manufacturer of drug trade, the composition, dosage, indication, kontraindikasi, attention, side effects, drug interactions, and packaging .
CD software is very suitable for the medical (doctor, pharmacist, nurse) or profession-related drugs, and even the general public. So I need to open the go-MIMS open or ISO, just installed in the computer, go the name of the medicine, jreng Bim salabim detail info information come out that we want the medicine.
INDO software consists of 4 items:
to order by email to:
with the number of orders, the address order, and the cost has been transferred
goods will be sent immediately after the cost of goods transferred to the account:
Bank Rakyat indonesia
a / n rizkon arisandi
Rek no: 098601001680508
Software "INDO" will meet the needs of more than 4000 drug information circulating in Indonesia based on the brochure and insert from the manufacturer, include: Name and manufacturer of drug trade, the composition, dosage, indication, kontraindikasi, attention, side effects, drug interactions, and packaging .
CD software is very suitable for the medical (doctor, pharmacist, nurse) or profession-related drugs, and even the general public. So I need to open the go-MIMS open or ISO, just installed in the computer, go the name of the medicine, jreng Bim salabim detail info information come out that we want the medicine.
INDO software consists of 4 items:
Trade Name Description
Loading trade name and drug manufacturers, the composition, dosage, indication, kontraindikasi, attention, side effects, drug interactions, and packaging.
Indeks Trading Name
Loading various trade names of drugs circulating in Indonesia for an active substance
Security Indeks Pregnancy
Security category includes drugs that include; A, B, C, D and X to the fetus.
Parameter Farmakokinetik
Loading Parameters Farmakokinetik essential medicines, which consists of: T1 / 2, Kel, Vd, Fel, f, EPB, pKa, mec, ura, dose, frequency of use, and Tmax.
to order by email to:
with the number of orders, the address order, and the cost has been transferred
goods will be sent immediately after the cost of goods transferred to the account:
Bank Rakyat indonesia
a / n rizkon arisandi
Rek no: 098601001680508
Category:
pharmaceutical,
products
19 Comments
Yoghurt or yogurt,milk is made through bacterial fermentation. Yoghurt can be made from any milk, milk including soybean. However, modern production at this time dominated milk caw. Fermentation of sugar milk (laktosa) laktat produce acids, which play a role in protein milk to gel like texture and smell that is unique in the yoghurt. Yoghurt is often sell what is in it, however, taste the fruit, vanilla or chocolate,are also on populer..example of product asoyghurt,more here ..
Category:
products,
yoghurt
5 Comments
About Me
- novi andi
- rizekon are just ordinary people who want to become a pharmacist, and the desire can learn to channel knowledge to anyone who requires a principle of a medical doctor, "MAKES ONE HEALTHY, THE NATURE HEALTH. creating, and sharing is beautiful"
