(2003; 148 pages)
16.2 All handling of materials and products, such as receipt and cleaning, quarantine, sampling, storage, labelling, dispensing, processing, packaging and distribution should be done in accordance with written procedures or instructions and, where necessary, recorded.
16.3 Any deviation from instructions or procedures should be avoided as far as possible. If deviations occur, they should be done in accordance with an approved procedure. The authorization of the deviation should be approved in writing by a designated person, with the involvement of the quality control department, when appropriate.
16.4 Checks on yields and reconciliation of quantities should be carried out as necessary to ensure that there are no discrepancies outside acceptable limits.
16.5 Operations on different products should not be carried out simultaneously or consecutively in the same room or area unless there is no risk of mix-up or cross-contamination.
16.6 At all times during processing, all materials, bulk containers, major items of equipment, and where appropriate, the rooms and packaging lines being used should be labelled or otherwise identified with an indication of the product or material being processed, its strength (where applicable) and the batch number. Where applicable, this indication should also mention the stage of production. In some cases it may be useful to record also the name of the previous product that has been processed.
16.7 Access to production premises should be restricted to authorized personnel.
16.8 Normally, non-medicinal products should not be produced in areas or with equipment destined for the production of pharmaceutical products.
16.9 In-process controls are usually performed within the production area. The performance of such in-process controls should not have any negative effect on the quality of the product or another product (e.g. cross-contamination or mix-up).