Sertifikasi GMP (Good Manufacturing Practice)

GMP (Good Manufacturing Practice)

Sertifikasi GMP (Good Manufacturing Practice) - A good manufacturing practice (GMP) is a production and testing practice that helps to ensure a quality product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation. Basic concepts of all of these guidelines remain more or less similar to the ultimate goals of safeguarding the health of the patient as well as producing good quality medicine, medical devices or active pharmaceutical products. In the U.S. a drug may be deemed adulterated if it has passed all of the specifications tests but is found to be manufactured in a condition which violates current goo manufacturing guideline. Therefore, complying with GMP is a mandatory aspect in pharmaceutical manufacturing.

Although there are a number of them, all guidelines follow a few basic principles:

• Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
• Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
• Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)
• Operators are trained to carry out and document procedures.
• Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented.
• Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
• The distribution of the drugs minimizes any risk to their quality.
• A system is available for recalling any batch of drug from sale or supply.
• Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.

GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the companys responsibility to determine the most effective and efficient quality process.

Sekarang ini terjadi peningkatan permintaan terhadap kepastian keamanan pangan dan kualitas yang terbaik oleh konsumen dan pemerintah.  Produksi makanan yang tidak aman dapat mengakibatkan keracunan makanan, penarikan produk, proses hukum/pengadilan yang panjang dan mahal dan tanpa disadari dapat merusak reputasi publik. Persyaratan pelanggan sebagai bagian dari bisnis global menuntut bahwa dalam rantai makanan harus dipastikan bahwa makanan diproses dengan memenuhi standar keamanan pangan mulai dari kebun sampai ke meja (from farm to table).

Good Manufacturing Practices (GMP) adalah sistem yang memuat persyaratan minimum yang harus dipenuhi oleh industri makanan dan kemasan, terkait dengan keamanan pangan, kualitas dan persyaratan hukum. 

Standar umum yang dipergunakan adalah Title 21 Code of Federal Regulation (CFR) part 110 

Good Manufacturing Practices in Manufacturing, Packing, or Holding Human Food and General Principles Food Hygiene, WHO/FAO International Code Practice. Standar ini adalah yang standar yang umum diterapkan dalam industri yang makanan dan kemasan.

Implementasi yang efektif dari System Management dengan menerapkan konsep Hygiene & Sanitation pada system Good Manufacturing Practices / GMP akan memberikan keyakinan dan manfaat dalam usaha industri makanan dan industri kemasan terkait

Manfaat
Meningkatkan kepercayaan pelanggan;
Meningkatkan image dan kompetensi perusahaan/organisasi;
Meningkatkan kesempatan perusahaan/organisasi untuk memasuki pasar global melalui produk/kemasan yang bebas bahan beracun (kimia, fisika dan biologi);
Meningkatkan wawasan dan pengetahuan terhadap produk;
Berpartisipasi dalam program keamanan pangan;

Hubungi kami Badan Sertifikasi GMP Terbaik di Indonesia

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