Added by Act 19 of 1972, s. 2.

6.1. All containers and closures shall comply with the pharmacopoeial or any other requirement, suitable sampling methods, sample sizes, specifications, test methods, cleaning procedures and sterilization procedures, when indicated, shall be used to assure that containers, closures and other component parts of drug packages are suitable and are not reactive, additive, adsorptive or leachable to an extent that significantly affects the quality or purity of the drug. 6.2. The drug product container shall be tested or re-examined as appropriate and approved or rejected and shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which these are unsuitable. 6.3 Container closure system shall provide adequate protection against foreseeable external factors in storage / transportation and use that may cause deterioration or contamination of the active pharmaceutical ingredient. 6.4. Bulk containers and closures shall be cleaned and, where indicated by the nature of the active pharmaceutical ingredient, sterilized to ensure that they are suitable for their intended use. 6.5. The container shall be conspicuously marked with the name of the product and the following additional information concerning : (a) quality and standards, if specified; (b) manufacturing licence number/drug master file number (whichever applicable), batch number; (c) date of manufacture and date of expiry; (d) method for container disposal (label shall give the methodology, if required); (e) storage conditions, if specified and name and address of the manufacturer, if available. 6.6. Areas for different operation of active pharmaceutical ingredients (bulk drugs) section shall have appropriate area which may be suitably partitioned for different operations.