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Section 8
Production work

As mentioned in section 13 of this code, drug production work should be done under the supervision and responsibility of an expert. Medicine production work should pay attention to the following things:-

(a) Before starting production, related tools or equipment or machines and rooms should be cleaned well and sterilized as needed. should be done,

(b) All equipment, machines and containers used for drug production should be clearly labeled as making related drugs throughout the production period,

(c) The person involved in the production work should wear clothes, shoes, hats, masks, gloves and glasses (safety goggles) etc. in a proper way, covering different parts of the body.

(d) Hands should be washed with disinfectant before entering the room where parenteral medicine is produced,

(e) The person involved in drug production should not have any communicable disease. The person's health should be tested from time to time. These types of written instructions should contain the following methods and guidelines for each drug:-

(1) The name, composition, type, type and amount of active ingredient of the drug to be produced and Formula,

(2) Drug manufacturing method,

(3) Various drug manufacturing operations Batch no. and to clearly label the name of the medicine,

(4) the quality, quantity or means of identification of the raw material used in each medicine after production or in any case during the production process. must be feasible,

(5) copy of the productQuality control to be done in each case, methods and details of test analysis and the names of the branches that perform these functions are clearly mentioned, and

(6) semi-preparative medicine and the instructions related to the storage location of the preparation medicine.

(G) Medicines or substances that are not related to the room where the manufacturing process of a medicine begins should be kept in a separate place in a way that does not bend,< /p>

(h) According to the method to be adopted for the production of drugs to be sterilized, the production should be started in a proper way and carefully. What is used in such medicines should be clearly labeled as to which has been sterilized and which has not,

(i) storing, mixing, dusting pesticides and antibiotics, Making tablets or putting them in capsules should be done in separate rooms. These rooms should have a good arrangement to ventilate separately,

(j) Batch record of production: The production record should contain a complete account and description of each batch of the product of any medicine. must Production records must state whether or not the drug has been produced completely according to the production method, whether or not it has been tested, and the name of the person who performed the test or analysis. Along with the production record, the batch record should be kept separately for at least 5 years. The prescription record should contain the following:-

(1) name, composition and formula of the drug,

(2) Date of commencement of production,

(3) Date of completion of production,

(4) the number or symbol giving the batch information,

(5) the quantity of raw materials used in the batch and the manner of identification,

(6) Theoretical production quantity obtained in each case and(7) The method and precautions adopted in each case in the production and if any particular thing is noted or noticed, it is regularly corrected. Records,

(8) procedures adopted for product control and their results,

(9 ) Sample of actual label,

(10) Details of the machine used in the production and its duration and packing materials,

(11) the correct and date of the specialist responsible for the product, and

(12) giving full information that the drug concerned is not below the prescribed level Quality control report.

(k) The manufactured drugs should be labeled as prescribed by law, and

(l) The production date and the expiry date as required should be disclosed on the label of the manufactured medicines.