生产工艺规程

beiwei5du

6.41 Master production instructions should include:
− The name of the intermediate or API being manufactured and an identifying document reference code, if applicable;
− A complete list of raw materials and intermediates designated by names or codes sufficiently specific to identify any special quality characteristics;
− An accurate statement of the quantity or ratio of each raw material or intermediate to be used, including the unit of measure. Where the quantity is not fixed, the calculation for each batch size or rate of production should be included. Variations to quantities should be included where they are justified;
− The production location and major production equipment to be used;
− Detailed production instructions, including the:
− sequences to be followed,
− ranges of process parameters to be used,
− sampling instructions and in-process controls with their acceptance criteria, where appropriate,
− time limits for completion of individual processing steps and/or the total process, where appropriate; and
− expected yield ranges at appropriate phases of processing or time;
− Where appropriate, special notations and precautions to be followed, or cross-references to these; and
− The instructions for storage of the intermediate or API to assure its suitability for use, including the labelling and packaging materials and special storage conditions with time limits, where appropriate.
关于记录中投料量的viriations大家是怎么确定的呢？？比如有的企业的批记录中规定投料量为100.00kg±0.50kg，而有的企业则规定100.00kg±1.00kg