SOP on Equipment Identification
1.0 Purpose: This SOP describes the requirements for Identification of equipment used in manufacture of a drug batch.
2.0 Scope: This SOP applies to Production staff.
3.0 Responsibility: Production Chemist to ensure that procedure is followed.
4.0 Materials and Equipment: As required
5.0 Procedure:
5.01 All equipment including major equipment are identified by a distinctive identification number or code.
5.02 The number of major equipment is recorded in batch production record to show that specific equipment is used in manufacture of each batch of a drug product.
5.03 All compounding and storage containers, processing lines and major equipment used during production of a batch of a drug product are properly identified at all times to indicate their contents and when necessary, phase of processing of batch.
5.04 All equipment and lines always bear a label showing their status – Clean, to be cleaned; or with product name, lot number and phase of processing.
5.05 The labeling of containers of materials in-process clearly define product, batch number and state of processing (e.g. granules,bulk tablet, capsules etc.).
5.06 When materials are to be transported to other sites, it may also be appropriate to place a label inside the container as an extra precaution in case outer label gets lost or defaced.