| Procedure For Labelling In Manufacturing and Packing Department |
1.0 OBJECTIVE: 1.1 To lay down a procedure for labelling in Manufacturing and Packing department. 2.0 SCOPE: 2.1 This procedure is applicable for the labelling in manufacturing and packing department. 3.0 RESPONSIBILITY: 3.1 Production Officer /Supervisor shall be responsible for implementation of the procedures as per this SOP(Labelling In Manufacturing and Packing Department ). 3.2 Head Production or his / her designee shall be responsible for compliance of the procedures. 3.3 ROPP : Roll On Pilfer Proof 3.4 IPQA : In-process Quality Assurance To read this SOP Click here SOP for Operation and Qualification Of Steam Sterilizer. 4.0 PROCEDURE: 4.1 FOR EQUIPMENT AND AREA OF WORK(Labelling In Manufacturing and Packing Department ) 4.1.1 ‘BATCH IN PROCESS’ Display Board OR Label for core area:- For any under process batch, a white display board outside the door affix with Stage, Product Name, Batch No., Batch Size, Mfg date, Exp date, Date of processing, Done by, checked by, verified by duly filled shall be displayed prominently on outside the processing area. (Use the WHITE colour BATCH IN PROCESS Label for machine and area, wherever the display board is not available). 4.1.2 ‘TO BE CLEANED’ Display Board:- When any equipment along with its area is subjected for cleaning after finishing of work, the information shall be put on display board outside the area. Display the previous product name, Batch No., Date, Done By, checked by, verified by and the cleaning procedure in the stage ‘A’ / ‘B’ (Tick the appropriate one). (Use the RED colour ‘TO BE CLEANED’ Label for machine and area, wherever the display board is not available) 4.1.2.1 Choice of procedure shall be either ‘A’ or ‘B’ depending upon the next product / batch. On batch-to-batch (same product) changeover, equipment shall be cleaned as per the procedure A of the respective SOP of cleaning of the equipment. On product changeover every equipment (including any idle equipment during previous process, if any) within the same area shall be cleaned as per the procedure B of the respective SOP of cleaning of the equipment. Unclean machine or area shall not be kept in unclean status for more than two days. 4.1.3 ‘CLEANED’ Display Board or LABEL: – When any equipment along with its area is cleaned as per its SOP, a ‘Cleaned’ word shall be mentioned on the display board with done by, checked by and verified by signature. A GREEN colour label shall be displayed in the record with Previous product, Batch No., ready for use, done by and checked by with sign and date, Verified by (sign/date). QA person will sign after verification of the equipment and area. NOTE:- The ‘CLEANED’ status of the equipment and area is valid only if the equipment and area is being used with in 24 hour , otherwise whenever it is taken for processing the equipment must be inspected again before us and thorough cleaning with procedure A or B (as required) must be done. After mentioning the ‘CLEANED’ status, equipment or machine or area shall be covered with the cling film/stretch wrap wherever any contact part of the equipment is exposed. 4.1.4 ‘NOT IN USE’:- When any equipment is Spare machines, a RED colored label with following information shall be placed: Equipment name , Equipment identity no., Last used for (Product), Batch No., Date, Checked by (sign & date). 4.1.5 ‘REJECTED’:- If any equipment is redundant or not for use or damaged beyond any repair, shall be removed from the site with proper authorization. Its name and identification number must be deleted from the equipment list so as to update the same periodically. Equipment shall be sent for disposal to the Engineering Department in coordination with Accounts, a RED colored label with following information shall be placed: Equipment name, used for last product, batch no Equipment identity no., Date, Checked by (sign & date). 4.1.6 UNDER MAINTENANCE: – A RED colored label put on machine, when any equipment is damaged and shall get repaired or serviced by the Engineering Department. 4.2 FOR INPROCESS MATERIALS:( Labelling In Manufacturing and Packing Department ) 4.2.1 STAGE LABELS: – A label shall be put on outside and inner side of the container containing in process materials. These labels shall consist of white colors with the following information: Product, Batch No., Batch Size, Mfg. Date, Done by, Checked by (sign and date), Gross wt., Tare wt., Net wt., Container No. Note: Gross wt., Tare wt. and Net wt., are not applicable for packaging components. Stages wherever the Quality Control testing is required before moving to the next stage, Production personnel shall put the next stage on the label itself. After completion of Quality Control testing upon conformance of the material, IPQA personnel shall put ‘APPROVED / HOLD / REJECTED’ sticker on all the containers of a batch, and then only further stages shall be preceded accordingly. NOTE: – The entire label shall be issued by Quality Assurance department through issuance register. 5.0 ABBREVIATIONS(Labelling In Manufacturing and Packing Department ) 5.1 Label : A brief description given for purpose of identification 5.2 SOP : Standard Operating Procedure 5.3 Mfg. Date : Manufacturing Date 5.4 Wt. : Weight |
