Product recall is a process for wit

Product recall is a process for withdrawing or removing a pharmaceutical product from the pharmaceutical distribution chain because of defects in the product or complaints of serious adverse reactions to the product. The recall might be initiated by the manufacturer/importer/ distributor or a responsible agency.
Quality assurance•
Quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made

with the object of ensuring that pharmaceutical products are of the quality required for their intended use.
Quality control•
Quality control covers all measures taken, including the setting of specifications, sampling, testing and analytical clearance, to ensure that starting materials, intermediates, packaging materials and finished pharmaceutical products conform with established specifications for identity, strength, purity and other characteristics.
Quality system•
An appropriate infrastructure, encompassing the organizational structure, procedures, processes and resources, and systematic actions necessary to ensure adequate confidence that a product (or services) will satisfy given requirements for quality.

• Quarantine
The status of starting or packaging materials, intermediates, or bulk or finished products isolated physically or by other effective means while a decision is awaited on their release, rejection or reprocessing.
• Shelf-life
The period of time during which a finished pharmaceutical product, if stored correctly, is expected to comply with the specification as determined by stability studies on a number of batches of the product. The shelf-life is used to establish the expiry date of each batch.
Standard operating• procedure (SOP)
An authorized, written procedure giving instructions for performing operations not necessarily specific to a given product but of a more general nature (e.g. equipment operation, maintenance and cleaning, validation, cleaning of premises and environmental control, sampling and inspection).
• Storage
The storing of pharmaceutical products up to the point of use.
• Validation
A documented program that provides a high degree of assurance that a specific process, method or system will consistently produce a result meeting pre-determined acceptance criteria.
Vehicle•
Vehicle refers to trucks, vans, buses, minibuses, cars, trailers, aircraft, railway carriages, boats and other means which are used to convey pharmaceutical products.

• Supplier:
A person or party which provide the concerned establishment, pharmaceutical products and materials on request. Suppliers may be agents, brokers, distributors, manufacturers or traders. Suppliers should be authorized by a competent authority.
Retest date:•
The date when a material should be re-examined to ensure that it is still suitable for use.
Normal Storage• Conditions
Means to practice storage under environmental conditions described as dry with a good ventilation within temperature degrees range between 15 to 25 degrees Celsius that could extend to 30 degrees Celsius as marginal limit. The storage environment should be protected from any external vapors or smells, contamination factors and extensive direct light.
Packaging material•
Any material, including printed material, employed in the packaging of a pharmaceutical product, but excluding any outer packaging used for transportation or shipment. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.
Specific Storage conditions:•
Some pharmaceutical products require specific conditions to be stored within, and needs special instructions for storage handling and methods.
Interpretation of• instructions included on the product label:
Not to exceed 30 Degree Celsius: means to store within the range from +2 to +30 Degrees Celsius.
 Not to exceed 25 Degree Celsius: means to store within the range from +2 to +25 Degrees Celsius
Not to exceed 15 Degree Celsius: means to store within the range from +2 to +15 Degrees Celsius.
Not to exceed 8 Degree Celsius: means to store within the range from +2 to +8 Degrees Celsius.
Do not store below 8 Degree Celsius: means to store within the range from +8 to +25 Degrees Celsius.
The product should be protected from humidity: means to protect it from conditions where humidity exceeds 60%, and should be kept in a humidity resistant container.
Keep away from light: means that should be stored in places not exposed to light. It should be kept in light proof containers.

Hasil (Bahasa Indonesia) 1:

Penarikan kembali produk adalah proses penarikan atau menghapus produk farmasi dari rantai distribusi farmasi karena cacat pada produk atau pengaduan serius reaksi yang merugikan untuk produk. Ingat mungkin diprakarsai oleh produsen/importir/distributor atau agen yang bertanggung jawab. Kualitas assurance•Jaminan kualitas adalah sebuah konsep luas yang meliputi semua hal-hal yang secara individual atau kolektif mempengaruhi kualitas produk. Ini adalah keseluruhan pengaturan yang dibuatobjek memastikan bahwa produk farmasi kualitas yang diperlukan untuk penggunaan mereka. Kualitas control•Kontrol kualitas meliputi semua langkah yang diambil, termasuk pengaturan spesifikasi, sampling, pengujian dan analisis clearance, untuk memastikan bahwa mulai bahan, zat antara bahan kemasan dan produk farmasi selesai sesuai dengan spesifikasi yang ditetapkan untuk identitas, kekuatan, kemurnian dan karakteristik lain. Kualitas system•Infrastruktur yang sesuai, meliputi struktur organisasi, prosedur, proses dan sumber daya, dan sistematis tindakan-tindakan yang diperlukan untuk memastikan keyakinan memadai bahwa produk (atau layanan) akan memuaskan diberikan persyaratan untuk kualitas.• KarantinaStatus mulai atau bahan Kemasan, zat antara, atau massal atau selesai produk terisolasi secara fisik atau dengan cara efektif lain sementara keputusan yang ditunggu mereka rilis, penolakan atau pengolahan.• Shelf-lifeThe period of time during which a finished pharmaceutical product, if stored correctly, is expected to comply with the specification as determined by stability studies on a number of batches of the product. The shelf-life is used to establish the expiry date of each batch. Standard operating• procedure (SOP)An authorized, written procedure giving instructions for performing operations not necessarily specific to a given product but of a more general nature (e.g. equipment operation, maintenance and cleaning, validation, cleaning of premises and environmental control, sampling and inspection).• StorageThe storing of pharmaceutical products up to the point of use.• ValidationA documented program that provides a high degree of assurance that a specific process, method or system will consistently produce a result meeting pre-determined acceptance criteria. Vehicle•Vehicle refers to trucks, vans, buses, minibuses, cars, trailers, aircraft, railway carriages, boats and other means which are used to convey pharmaceutical products.• Supplier:A person or party which provide the concerned establishment, pharmaceutical products and materials on request. Suppliers may be agents, brokers, distributors, manufacturers or traders. Suppliers should be authorized by a competent authority. Retest date:•The date when a material should be re-examined to ensure that it is still suitable for use. Normal Storage• ConditionsMeans to practice storage under environmental conditions described as dry with a good ventilation within temperature degrees range between 15 to 25 degrees Celsius that could extend to 30 degrees Celsius as marginal limit. The storage environment should be protected from any external vapors or smells, contamination factors and extensive direct light. Packaging material•Any material, including printed material, employed in the packaging of a pharmaceutical product, but excluding any outer packaging used for transportation or shipment. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product. Specific Storage conditions:•Some pharmaceutical products require specific conditions to be stored within, and needs special instructions for storage handling and methods. Interpretation of• instructions included on the product label: Not to exceed 30 Degree Celsius: means to store within the range from +2 to +30 Degrees Celsius. Not to exceed 25 Degree Celsius: means to store within the range from +2 to +25 Degrees Celsius Not to exceed 15 Degree Celsius: means to store within the range from +2 to +15 Degrees Celsius. Not to exceed 8 Degree Celsius: means to store within the range from +2 to +8 Degrees Celsius. Do not store below 8 Degree Celsius: means to store within the range from +8 to +25 Degrees Celsius. The product should be protected from humidity: means to protect it from conditions where humidity exceeds 60%, and should be kept in a humidity resistant container. Keep away from light: means that should be stored in places not exposed to light. It should be kept in light proof containers.