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
Schedules: Schedule A, Schedule B, Schedule C, Schedule D, Schedule E1, Schedule F, Schedule G, Schedule H, Schedule H1, Schedule I, Schedule J, Schedule K, Schedule L1, Schedule M, Schedule M1, Schedule M2, Schedule M3, Schedule N, Schedule O, Schedule P, Schedule Q, Schedule R, Schedule S, Schedule T, Schedule U, Schedule V, Schedule W, Schedule X, Schedule Y
Schedule K (Rule 123):
Schedule K describes the class of drugs and their extent and condition of exemption from all provisions of drug and cosmetic act.
Schedule K allowed some drugs from falling under drug and cosmetic act, and allow to use, sell without provisions of drug and cosmetic act.
For more detail refer Drug and Cosmetic Act
Schedule K (Rule 123):
Schedule K describes the class of drugs and their extent and condition of exemption from all provisions of drug and cosmetic act.
Schedule K allowed some drugs from falling under drug and cosmetic act, and allow to use, sell without provisions of drug and cosmetic act.
For more detail refer Drug and Cosmetic Act
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