Good Manufacturing Practice or GMP

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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:

GMP requires that all manufacturing and testing equipment has been qualified as suitable for use
that 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


or you are interested in our collection is this?

you are interested or need an explanation? please contact us

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14 Responses
  1. yub personal page

    yes...This is applicable more on food and pharma manufacturing.Whereas, in electronics and solar they use SPC or statistical process control.NICE POST!

  2. prafangga permana

    Nice Posting friend

  3. Firex Santos

    sob... berkunjung...... kunjungin balik sob... and jangan lupa koment balik yak... di

  4. rinto

    nice post

  5. mantan copet

    Salam Sahabatku....
    Kunjungan perdana, salam kenal aja dulu...
    Maaf, saya memang hanya mantan manusia bejat, tapi sumpah, saya sudah benar-benar insyaf.
    Satu yg membuat saya yakin bahwa saya pasti bisa berubah menjadi orang yg lebih baik, yaitu Kuasa Tuhan. Nothing Impossible, ndak ada yg ndak mungkin.
    Selama kita mau berusaha, pasti jalan untuk itu akan terbuka.
    Maka dari itulah kali ini saya akan berbagi sedikit kisah hidup saya selama masa transisi itu, kalo sahabatku berkenan, saya tunggu motivasinya buat saya di Mantan Copet Itu Akhirnya Jadi Seorang Pengusaha.

    Trimakasih Sahabatku.

  6. mantan copet

    trimakasih banyak Sahabatku sudah mau merespons undanganku, matur thank you

  7. soff-tis

    easy learning work flow,this remembering me about kepner and tregoe troubleshooting work flow proses for manufacturing product.

  8. willy weblog

    Link download sudah ada di postingan sob. Tapi tak kasih di sini aja biar sob downloadnya gampang yah...

    Ok selamat mencoba sob

  9. ulin nuha

    good info thank

  10. rochim

    BLOG yang MANTAB, Sob. Penuh dengan KARYA SENI.
    Jadi Pengen PIPIS, Ha...ha..ha.

  11. ritz

    @all my friends:
    thanks for comment, good luck always make friends all

  12. BMEUB

    nice collection of instruments.. :)

  13. Artikel Komputer

    Thankh infonya tentang Good Manufacturing Practice

  14. The Crazy World

    nice info and nice article bro :)

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