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 are the set of provisions for classifications of drugs, forms, fees, standards, requirements and regulations related to drugs and cosmetics under Drug and Cosmetic Act, 1940 and Rules, 1945. Here drugs includes pharmaceutical, Ayurvedic (including siddha), unani and tibb system of medicines, homeopathy etc. Schedules are divided alphabetically and named also alphabetically like Schedule A, Schedule B etc till Schedule Y. Schedule Z is proposed but not implemented yet. Schedules are important part of Drug and Cosmetic Act 1940 & Rules, 1945 . Every schedule contains specific information as discussed below. Schedule A: Schedule A describes application forms and licenses types. Schedule B: Schedule B describes Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories Schedule B1: Schedule B1 describes fees for the test or analysis by the pharmacopoeial laboratory for indian medicine (plim) or the government analyst Schedule C:
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