Handling of materials
Article 29
1. Handling of materials including aspects related to the receipt, identification, quarantine, storage, handling, sampling, testing and approval or rejection, shall be done in accordance with written procedures or instructions and recorded as appropriate. 2. Suppliers of materials used in the manufacturing of the active substance shall be approved by the quality unit after verifying the suitability thereof. In case of critical materials, qualification of the suppliers is required. The level of supervision shall be proportionate to the risks posed by the individual materials. 3. All materials shall be purchased in compliance with the relevant specification. 4. Where the supplier of a critical material is not the manufacturer of that material, the name and address of that manufacturer shall be known by the intermediate or active substance manufacturer. 5. Changes in the source of supply of critical raw materials shall be treated according to Chapter XIII.