Amendment status not verified — confirm the current text below against the official source.
Specification 17.1 For raw materials and packaging materials. - They shall include- (a) the designated name and internal code reference; (b) reference, if any, to a pharmacopoeial monograph; (c) qualitative and quantitative requirements with acceptance limits; (d) name and address of manufacturer or supplier and original manufacturer of the material; (e) specimen of printed material; (f) directions for sampling and testing or reference to procedures; (g) storage conditions; and (h) maximum period of storage before re-testing. 17.2 For product containers and closures:– 17.2.1 All containers and closures intended for use shall comply with the pharmacopoeial requirements. Suitable validt. test methods, sample sizes, specifications, cleaning procedure and sterilization procedure, wherever indicated, shall be strictly followed to ensure that these are not reactive, additive, absorptive, or leach to an extent that significantly affects the quality or purity of the drug. No second hand or used containers and closures shall be used. 17.2.2 Whenever bottles are being used, the written schedule of cleaning shall be laid down and followed. Where bottles are not dried after washing, they should be rinsed with de-ionised water or distilled water, as the case may be. Drugs and Cosmetics Rules 1945 440 17.3. For in-process and bulk products. - Specifications for in-process material, intermediate and bulk products shall be available. The specifications should be authenticated. 17.4 For finished products. - Appropriate specifications for finished products shall include: - (a) the designated name of the product and the code reference; (b) the formula or a reference to the formula and the pharmacopoeial reference; (c) directions for sampling and testing or a reference to procedures; (d) a description of the dosage form and package details; (e) the qualitative and quantitative requirements, with the acceptance limits for release; (f) the storage conditions and precautions, where applicable, and (g) the shelf-life. 17.5 For preparation of containers and closures. - The requirements mentioned in the Schedule do not include requirements of machinery, equipments and premises required for preparation of containers and closures for different dosage forms and categories of drugs. The suitability and adequacy of the machinery, equipment and premises shall be examined taking into consideration the requirements of each licensee in this respect.