Principle
- All materials, which may affect product quality and safety, should be controlled and meet defined specifications. The level of control of each material should reflect its use and potential risk to the product.
General
- All handling of materials, such as receipt and quarantine, sampling, release, storage, and labelling, should be performed in accordance with written procedures and, where necessary, recorded.
- There should be a record of the receipt of material, which should include the description, date of receipt, quantity, supplier, and as applicable, lot or batch number, or a unique identifying number.
- There should be approved quality control specifications for any material, which may have a direct effect on the quality of the product. As applicable, the specifications should include the following information:
- description of the materials;
- instructions for sampling and testing or reference to procedures;
- qualitative and quantitative requirements with acceptance limits, including the key physical, chemical or biological properties and the criteria for test and limits.
- Incoming materials should be quarantined and assessed to ensure that they meet approved specifications, before being released for use.
- Where appropriate, the maximum period of storage before re-assessment should be determined.
- All materials should be stored under appropriate conditions. The status of any material should be evident from the visual appearance of its status label or by alternate equivalent systems.
- When not under the direct control of an authorised person, all labels for critical material should be secured in a locked storage area accessible only to authorised personnel.
- Material, which does not conform to specifications, should be prevented from unintended use and its disposition recorded.
- Any defect or problem associated with a material used in processing should be notified to the supplier and, if applicable, to the national therapeutic goods authority.
- Materials should only be obtained from suppliers that have been evaluated and approved to ensure their ability to supply material meeting requirements. Records should be maintained.
- Reagents should be of appropriate quality and suitable for intended use.
- Products returned from the customer and which have left the control of the manufacturer should be destroyed unless without doubt their quality is satisfactory. They may be considered for re-supply only after they have been critically assessed by the Quality Manager or delegate in accordance with a written procedure. The nature of the product, any special storage conditions it requires, its condition and history, and the time elapsed since it was issued should all be taken into account in this assessment. Where any doubt arises over the quality of the product, it should not be considered suitable for re-supply. Any action taken should be appropriately recorded.