Master production instructions
Article 25
1. Master production instructions for each active substance and intermediate thereof shall be prepared, dated, and signed by one person and independently checked, dated, and signed by a person in the quality unit. 2. The master production instructions referred to in paragraph (1) shall include: (a) the name of the active substance or intermediate thereof being manufactured and an identifying document reference code, if applicable; (b) a complete list of raw materials and intermediates designated by names or codes sufficiently specific to identify any special quality characteristics; (c) 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 shall be included. Variations to the quantities of raw materials or intermediates used shall be included where they are justified; (d) the production location and major production equipment to be used; (e) detailed production instructions, including: — 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 the total process, where appropriate, — expected yield ranges at appropriate phases of processing or time, — where appropriate, special notations and precautions to be followed, or cross references to these, — the instructions for storage of the active substance or intermediate thereof to assure its suitability for use, including the labelling and packaging materials and special storage conditions with time limits, where appropriate.