I. Particulars to be shown in the manufacturing records: (1) Serial number. (2) Name of the product. (3) Lot or Batch size. (4) Lot or Batch number. (5) Date of commencement of manufacture and date when manufacture was completed. (6) Names of all ingredients, quantities required for the lot/batch size, quantities actually used. (7) Control reference numbers in respect of raw materials used in formulation. (8) Reference to analytical report numbers or unique code. (9) Actual production and packing particulars indicating the size and quantity of finished packings. (10) Date of release of finished packing for distribution or sale. (11) Signature of the expert staff responsible for the manufacture. II. Records of raw materials: Records in respect of each raw material shall be maintained indicating the quantity received, control reference number, the quantity issued from time to time, the names and batch numbers of the products for the manufacture of which the said quantity of r
Pharmaceutical Products are the products which are intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals.
Pharmaceutical products may include drugs, medicines, surgical, medical devices and other related products.
According to WHO, " Pharmaceutical products – more commonly known as medicines or drugs – are a fundamental component of both modern and traditional medicine. It is essential that such products are safe, effective, and of good quality, and are prescribed and used rationally."
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