| Procedure Of Disposal Of Used Aids, Non-Recoverable In-Process Material And Finished Products |
1.0 OBJECTIVE: 1.1 To lie down a procedure for disposal of used aids, non-recoverable In-process material and finished products. 2.0 SCOPE: 2.1 This procedure is applicable for disposal of used aids, non-recoverable In-process material and finished products. 3.0 RESPONSIBILITY: 3.1 Production Officer / Supervisor shall be responsible for implementation of the procedure. 3.2 Head of Production or his / her designee shall be responsible for compliance of the procedure. 4.0 PROCEDURE: 4.1 Procedure in various manufacturing sections. 4.1.1 All discarded polybags (used for manufacturing of product, raw materials, semi finished stage, etc.) are collected in a container labelled as ‘Waste bin’. These poly bags are collected by housekeeping person and sent to scrap yard. 4.1.2 Torn / Defaced Labels like “BATCH IN PROCESS”, “TO BE CLEANED”, “UNDER CLEANING”, used strings, adhesive tapes, used cleaning cloths are collected in the closed container labelled as ‘waste bin’. These are then collected by housekeeping person and sent to scrap yard along with polybags for disposal. 4.1.3 Rejected non-conforming in-process products shall be destroyed by dispersing / dissolving in sufficient quantity of potable water (not less than 100 times the material volume) and then draining it. 4.1.4 Disposal of Drug & Cosmetic: Rejected Drug & Cosmetic during the initial run of machine setting, respectively, or from any non-conformance necessitating rejection, shall be destroyed. 4.1.5 Disposal of dust: Dust collected from vacuum cleaner / dust extractor is destroyed. To read this SOP click here SOP for Cleaning And Sanitization In Production Area. 4.2 Procedure in other packaging section STEP I: After the batch completion, collect, count and weigh rejected empty tubes/bottles/containers in a thick polybag and suitably labelled. These polybags containing rejected materials shall be stored separately in a designated area & that shall be secured. STEP II: Rejected packaging materials / excess of overprinted packaging materials e.g. cartons, duplex cartons, corrugated boxes, etc. shall be collected batch wise in polybags, labelled suitably indicating the Status, Quantity, Batch No., Mfg Date, Exp. Date, etc. Immediate destruction of rejected material is essential to preclude any potential mix-up, misuse or accidental use. Rejected material shall be destroyed under the supervision of designated production personnel by the following methods: 4.2.1 Rejected excess packaging material or excess overprinted packaging material shall be destroyed by shredding under the supervision of designated production personnel. 4.2.2 Defective empty tubes/bottles/vials/containers are cut into pieces under the supervision of Production Supervisor / Officer. 4.2.3 The destruction of rejected materials shall be recorded in ‘Reconciliation of packaging materials’ of the relevant batch BMR. 4.2.4 Collect the all shredded or turn off packaging material separately in polybags and shall be disposed. |
