Labelling , Purpose :
Labelling , To describe the procedure for status labeling to identifying correct status of Equipment, area, Stage of product, Raw Material & Packaging Material at a given point of time.
Labelling , Scope :
This procedure is applicable for all materials/products received and stored in General Block & Sterile Block at XX Pharmaceuticals Ltd. that has the potential to affect GMP and quality, safety or efficacy of the finished product.
This procedure is also applicable for control of status identifying labels, process label and product labels used in Production, Warehouse, Quality Control and Quality Assurance departments in General Block & Sterile Block at XX Pharmaceuticals Ltd.
Definitions / Abbreviation:
[][]Labeling: Displaying status and identity of a material or a thing.
Responsibilities:
[][]The roles and responsibility is as follows:
Concerned Department
[][]Concerned department Officers/ Executive shall be responsible to carry out the activity as per procedure.
[][]To affix the status label as per procedure.
Head, Concerned Department
[][]Concerned Department Heads shall be responsible for effective implementation of procedure and activities.
Quality Assurance
[][]To ensure implementation of labeling procedure & proper labeling as per SOP.
Manager, Quality Assurance
[][]Approval of the SOP.
[][]To ensure the overall implementation of the SOP.
Procedure:
[][]In order to avoid mix-ups and contamination, for easy identification and traceability, of product and to ensure working as per GMP standards it is important to affix status label at each stage of process on equipment’s, products, containers, accessories and areas. Labels of various types are used in manufacturing functions.
[][]The purpose, type and use of each label are described as below.
General procedures for label handling:
[][]Every status-identifying label shall have distinctive format number and master copy for all computers generated and printed label formats shall be preserved securely under lock and key with Manager, Quality Assurance.
[][]Each and every container of active pharmaceutical ingredients (APIs), excipients, raw materials, intermediate products, primary and printed packaging components will have to be labeled denoting proper status.
[][]Every supplier batch will have status label (e.g. Passed label) with one unique batch/ lot number.
[][]For tertiary packing materials (product nonspecific i.e. shipper carton, master carton) pallet wise labeling process will be followed.
[][]All labels will be preprinted self-adhesive labels which provide blank space for printing/ writing necessary information.
[][]After printing/ generating of status label an authorized person will verify the correctness of printing.
[][]Containers/packs where self-adhesive label cannot be pasted securely (Sack/ polythene bag) transparent tapes will be used at every side for affixation. Stapler pin will never be used for affixation of label.
[][]No material/ product/equipment without status label shall be stored either in the warehouse or production floor.
[][]Warehouse personnel cannot issue material from any container to production where ‘PASSED’ label is not available.
[][]During dispensing of active raw materials, Officer/ Executive will ensure that every container contains three status label (QUARANTINED, SAMPLED, UNDER TEST and PASSED).
[][]In case of other raw materials (excipients) & packaging materials, all containers/ pack/ pallet must have ‘UNDER TEST’, ‘PASSED’ and ‘QUARANTINED’ label. ‘SAMPLED’ labels will be found between ‘QUARANTINED’ and ‘UNDER TEST’ label only on containers from which the samples were taken.
[][]Label must not be applied on the container lids.
[][]Labels will be applied on the body of the containers so that it will be easily visible. Label must not be overwritten and erased out.
[][]Labels will be handled securely in a segregated manner (under the custody of an authorized person) with controlled access.
Quarantined Label:
[][]After receipt and checking of incoming materials, warehouse Officer/ Executive will print ‘QUARANTINED’ labels with necessary information for all containers/packs for each batch of materials.
[][]Authorized warehouse personnel will provide all the entry required for ‘QUARANTINED’ label.
[][]Warehouse Officer/ Executive will verify and ensure that all the information printed on the labels of first sheet is correct and then will give command to authorized warehouse personnel for printing total ‘QUARANTINED’ labels required for the respective lot. Any label with printing error will be destroyed instantly.
[][]Warehouse Officer/ Executive will sign (issued by) and authorized person of the warehouse will affix all ‘QUARANTINED’ labels on each container of the incoming materials.
[][]This label is printed with black overprint on Orange background.
Approved Label:
[][]Quality Assurance Executive shall affix the ‘Approved Label’ on respective process container after receiving the certificate of analysis of that material / Product from QC.
[][]Quality Assurance Executive shall issue this label to approving In-process Granules/Powder, Uncoated /Coated Tablet for Work in progress.
[][]This label is printed with black overprint on Blue background.
Sampled Label:
[][]On receipt of Good Received Note (GRN) from warehouse, QC personnel will follow the SOP for Raw material sampling and release procedure or SOP for Packing material sampling and release procedure to determine the sampling plan and the number of the containers to be sampled.
[][]QC Officer/ Executive/ authorized person will issue and print required ‘SAMPLED’ labels according to sampling plan.
[][]After sampling, duly signed ‘SAMPLED’ label will be affixed on the containers or packs from which samples are withdrawn.
[][]The ‘SAMPLED’ label will be affixed beneath the ‘QUARANTIED’ label in a cascading manner (slight overlapping) without hiding any information of ‘QUARANTIED’ label.
[][]This label is printed with black overprint on Yellow background.
Hold Label:
[][]Manager, Quality Assurance may hold any raw material, packaging material or finished product when necessary.
[][]Quality Assurance personnel will print ‘HOLD’ label with necessary information.
[][]After signed by authorized person, Quality Assurance personnel will affix ‘HOLD’ label on the pallet/ container that will be hold for long time for a decision of passing or rejection.
[][]When final decision of passing or rejection is taken, Quality Assurance personnel will remove the ‘HOLD’ label and destroy them. Then, ‘PASSED’/ ‘REJECTED’/ ‘APPROVED’ labels will be affixed.
[][]This label is printed with black overprint on orange background.
Passed Label:
[][]QC Officer/ Executive will follow the SOP for Raw material sampling and release procedure or SOP for packing material sampling and release procedure and issue the ‘PASSED’ label.
[][]QC officer / Executive will take required sheets of blank ‘PASSED’ labels. The quantity of ‘PASSED’ label will be based on number of containers/packs for each batch of materials
Officer/ Executive, QC will provide all the entry required for ‘PASSED’ labels and take the print-out of one page first.
[][] Another Officer/ Executive, QC will verify and ensure that all the information printed on the first sheet of labels is correct and then will give the command for printing total ‘PASSED’ labels required for the respective lot. Any label with printing error will be destroyed instantly. Officer/ Executive, QC will sign ‘PASSED’ labels.
[][]Authorized QC person will affix the ‘PASSED’ label on each and every single container of raw materials or packaging materials with the help of warehouse personnel.
[][]‘PASSED’ label will be affixed just beneath the ‘UNDER TEST’ label in a cascading manner (slight overlapping) without hiding any information of previous label.
[][]This label is printed with black overprint on Green background.
Rejected Label:
[][]QC Officer/ Executive will follow the SOP for Raw material sampling and release procedure or SOP for packing material sampling and release procedure and issue the ‘REJECTED’ label.
[][]QC officer will take required sheets of blank ‘REJECTED’ labels. The quantity of ‘REJECTED’ label will be based on number of containers/packs for each batch of materials
[][]Officer/ Executive, QC will provide all the entry required for ‘REJECTED’ labels and take the print-out of one page first. Another Officer/ Executive, QC will verify and ensure that all the information printed on the first sheet of labels is correct and then will give the command for printing total ‘REJECTED’ labels required for the respective lot. Any label with printing error will be destroyed instantly.
[][]Manager, QC will sign ‘REJECTED’ labels.
[][]Authorized QC person will affix the ‘REJECTED’ label on each and every single container of raw materials or packaging materials with the help of warehouse personnel.
[][]‘REJECTED’ label will be affixed just beneath the ‘QUARANTIED’ label or ‘UNDER TEST’ label in a cascading manner (slight overlapping) without hiding any information of previous label.
[][]This label is printed with black overprint on Red background.
Under Retest Label:
[][]Ware house Officer will identify any requirement for retesting of materials and immediately paste a ‘UNDER RETEST’ label on the container just beneath the previous ‘PASSED’ label and transfer the material to quarantined area. Warehouse Officer will inform the Manager, QC to arrange sampling for retesting
[][]This label is printed with black overprint on Yellow background.
Returned label
[][]The ‘RETURNED’ Label is displayed on the container/material for identification of Product status.
[][]Concerned Department shall affix this label on excess material that is to be left after Primary Processing, e.g Drying/ Pulverization/ packaging operation.
[][]Ensure that the materials returned are clean, free of dust, properly covered and in uniform countable bundles or pack.
[][]This label is printed with black overprint on White background.
Cleaned Card Label
[][]The “CLEANED” label is displayed for the identification status of the equipment after completion of cleaning activity.
[][]Use this label after complete cleaning, as per SOP.
[][]In case of start of the operation, filled this label to be affixed in BMR/BPR.
[][]This label is printed with black overprint on green background.
[][]Following are the details to be filled up in the respective blank spaces. Label to be filled by operator / supervisor.
[][]Equipment Name: Name and/or ID no of the equipment, which is cleaned.
[][]Previous Product: Name of the product for which cleaning activity is completed in that particular equipment.
[][]Batch No.: Batch No. of the above product.
[][]Date of cleaning: Date on which equipment is cleaned.
[][]Use on or before: Date before which equipment can be used.
[][]Cleaned by: Signature or name of the person by whom equipment is cleaned.
[][]Checked by: Signature of production supervisor after verification of the filled contents in the label and after visual verification of cleanliness of the equipment.
[][]Verified by: Signature of the QCOM person, after visual verification of cleanliness of the equipment’s.
[][]To be used for product: The product which will be taken for process after the equipment cleaning.
[][]Batch No.: Batch no. of the product which will be taken for process after equipment cleaning.
Partially Cleaned Label
[][]The PARTIALLY CLEANED label is displayed for the identification status of the equipment after completion of cleaning activity.
[][]Use this label after partial cleaning, as per SOP.
[][]In case of start of the operation, filled this label to be affixed in BMR/BPR.
[][]This label is printed with black overprint on Yellow background.
[][]Followings are the details to be filled up in the respective blank spaces. label to be filled up by the operator/ supervisor.
[][]Equipment Name: Name and/or code no of the equipment, which is cleaned.
[][]Previous Product: Name of the product for which cleaning activity is completed in that particular equipment.
[][]Batch No.: Batch No. of the above product.
[][]Date of cleaning: Date on which equipment is cleaned.
[][]Use on or before: Date before which equipment can be used.
[][]Cleaned by: Signature or name of the person by whom equipment is cleaned.
[][]Checked by: Signature of production supervisor after verification of the filled contents in the label and after visual verification of cleanliness of the equipment.
[][]Verified by: Signature of the QCOM person, after visual verification of cleanliness of the equipment’s.
[][]To be used for product: The product which will be taken for process after the equipment cleaning.
[][]Batch No.: Batch no. of the product which will be taken for process after equipment cleaning.
To be Clean Label:
[][]This label is displayed for the identification status of the equipment, accessories and containers after its use.
[][]Followings are the details to be filled up in the respective blank spaces. label to be filled up by the operator/ supervisor.
[][]Previous Product: Name of the product for which processing activity is completed in that particular equipment.
[][]Batch No.: Batch No. of the above product.
[][]Signature: Signature of the production supervisor after verification of the filled contents in the label.
[][]Date: Date on which the equipment is due for cleaning.
[][]This label is printed with black overprint on Orange background.
Loose Label:
[][]‘Loose’ Label is to be affixed on loose container/shipper by Production Department.
[][]This label is printed with black overprint on White background.
[][]Executive, Production will provide all the entry required for ‘Loose’ labels and take the print-out. Any label with printing error will be destroyed instantly.
Material Dispensing Slip Label:
[][]This label is displayed for the identification status of the Dispensed Material.
[][]Use this label during of dispensing of material as per SOP.
[][]Officer/ Executive, Production will provide all the entry required for this label and take the print-out.
[][]In case of start of the operation, Executive, Production will affix this label in BMR.
[][]This label is printed with black overprint on White background.
[][]Followings are the details to be filled up in the respective blank spaces.
[][]Balance No.: Name of the Balance ID
[][]Operation: Material dispense for either Granulation or Coating.
[][]Material: Name of the Raw material
[][]Code: Code No. of the Raw material
[][]Lab Ref. No.: Lab Control No. of the Raw material
[][]Product: Name of the product that is to be manufactured.
[][]Batch No. : Batch no. of the concerned product.
[][]Batch size: Actual batch size of the concerned product.
[][]Gross Wt.: Total weight (wt) of the filled container without lid in kilogram (kg).
[][]Tare wt.: Weight of the empty container along with Polyethylene bags without lid before taking it in use in kg.
[][]Net Wt.: Subtract the tare wt. from gross wt. in kg.
[][]Container No.: Number of that particular container out of total no. of container used for the above batch.
[][]Dispensed by: Signature of dispensing Operator
[][]Checked by: Signature of Production Executive after verification of the filled contents in the label.
[][]Verified by: Signature of QCOM officer after verification of the filled contents in the label.
Process Label:
[][]This label is displayed on the container for identification of the product status.
[][]This label is to be used on the container during the manufacturing stage. For Example: Under sifting, under granulation, under solution preparation, Ready for Granulation / Drying / [][]Blending / Solution ready for coating.
[][]This label is printed with black overprint on White background.
[][]Following are the details of preprinted label to be filled up in the respective blank spaces and to be filled by operator / supervisor.
[][]Product: Name of the product collected / to be collected in the container.
[][]Batch No.: Batch no. of the concerned product.
[][]Status: Stage in which the product is ready for next step.
[][]Container No.: Number of that particular container out of total no. of container used for the above batch.
[][]Batch Size: Actual batch size of the concerned product.
[][]Mfg. Date & Exp. Date: Manufacturing and Expiry date of the concerned product.
[][]Gross wt.: Total weight (wt) of the filled container without lid in kilogram (kg).
[][]Tare wt.: Weight of the empty container along with Polyethylene bags without lid before taking it in use in kg.
[][]Net wt.: Subtract the tare wt. from gross wt. in kg.
[][]Checked by: Signature of Production officer after verification of the filled contents in the label.
Product Label:
[][]This label is displayed on the Shipper for identification of the product status.
[][]This label is to be used on the Shipper during the Secondary Packaging Operation.
[][]This label is printed with black overprint on White background.
[][]Following are the details of preprinted label to be filled up in the respective blank spaces and to be filled by operator / supervisor.
[][]Product: Name of the product collected / to be collected in the shipper.
[][]Batch No.: Batch no. of the concerned product.
[][]Mfg. Date & Exp. Date: Manufacturing and Expiry date of the concerned product.
[][]Pack Quantity: Total no. of pack in Shipper.
[][]Sr. No.: Total No. of Shipper
[][]Packed by: Name / sign of the Operator /Supervisor who are involved in shipper Making & closing.
[][]Storage Condition: Storage Condition of the concerned product.
Area / Equipment Label:
[][]This label is used to exhibit the process that is being carried out in the area/equipment, tick (√) whichever is applicable.
[][]This label is printed with black overprint on Green background.
[][]The area is labeled at the start-up of the batch.
[][]Following are the details to be filled up in the respective blank spaces. Label to be filled by operator / supervisor.
[][]Product: Name of the product taken or to be taken for processing on that particular equipment.
[][]Batch No.: Batch number of the above product.
[][]Batch size: Actual batch size in written in the BMR.
[][]Status: Particular stage of activity in process.
[][]Checked by: Signature of Production supervisor after verification of the filled contents in the label.
[][]Date: Date on which the process takes place.
Retention Sample:
[][]QC / QA officer shall affixed sample Label on the sample Poly bag or container which is to be sample for retaining.
[][]This label is printed with black overprint on White background.
[][]Officer/ Executive, QC or QCOM will provide all the entry required for ‘Retention Sample’ labels.
Cleaned Label:
[][]This label is displayed for the identification status of the accessories and containers after completion of cleaning activity.
[][]This label should not be attached with BMR/BPR.
[][]This label on containers and accessories should be defaced with a cross-line and destroyed when taken for use.
[][]In case of start of the operation, this label has to be removed from container and ‘ Process’ label to be affixed.
[][]In case of start of the operation, this label has to be removed from accessories and ‘Area/ Equipment’ label to be affixed.
[][]This label is printed with black overprint on Green background.
Under Test Label:
[][]This label is displayed on the container/ Packet for the identification status of the material/product after sampling for QC Test.
[][]QC / QCOM Executive shall affix this Label after completion of sampling activity.
[][]This label is printed with black overprint on Yellow background.
Annexure: Download all here
Annexure-I: Blank format for ‘Quarantined’ label.
Annexure-II: Blank format for ‘Approved’ label.
Annexure-III: Blank format for ‘Sampled’ label.
Annexure-IV: Blank format for ‘Hold’ label.
Annexure-V: Blank format for ‘Passed’ label.
Annexure-VI: Blank format for ‘Rejected’ label.
Annexure-VII: Blank format for ‘Under Retest’ label.
Annexure-VIII: Blank format for ‘Returned’ label.
Annexure-IX: Blank format for ‘Cleaned’ label.
Annexure-X: Blank format for ‘Partially Cleaned’ label.
Annexure-XI: Blank format for ‘To Be Cleaned’ label.
Annexure-XII: Blank format for ‘Loose’ label.
Annexure-XIII: Blank format for ‘Material Dispensing Slip’ label.
Annexure-XIV: Blank format for ‘Process’ label.
Annexure-XV: Blank format for ‘Product’ label.
Annexure-XVI: Blank format for ‘Area/ Equipment’ label.
Annexure-XVII: Blank format for ‘Sample’ label.
Annexure-XVIII: Blank format for ‘Retention Sample’ label.
Annexure-XIX: Blank format for ‘Cleaned’ label.
Annexure-XX: Blank format for ‘Under Test’ label.