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| Brief description of Production Operation for Ointments, Creams/Gels manufacturing : |
- Materials in dirty containers or original containers of manufacturers are not received in the manufacturing area.
- It is ensured that measuring and dispensing devices such as scoops, spoons, etc do not contaminate any materials. All equipments used for handling the materials will be cleaned immediately after each use.
- All materials are weighed into clean, tared and labeled containers. The label contains name of the product, Product Batch No., Manufacturing date, Expiry date, Batch size, Name of the material, Analytical Report No. etc., and net Weight, dispensed by and checked by signatures.s
- Dispensing is not performed in the manufacturing area, but it is carried out in a seperately designated dispensing booth by stores.
- Before commencing manufacturing process, the supervisor will ensure that the manufacturing area and the equipment used for manufacturing are clean and labeled and will get the same certified in the batch production record by Quality Assurance Department.
- De-mineralised water collected by the process mentioned in the “SOP for collection of De-mineralised water” will be used for production. For manufacturing purpose, boiled and cooled Demineralised water is used. The DM water collected in storage vessel is heated and cooled by means of plate heat exchanger. The Demineralised water collected by this process will be tested for specifications laid down for DM water, before use.
- The required quantity of DM water is transferred from DM water storage vessel to manufacturing area by means of SS loop distribution system. This water is collected in storage vessel.
- The steps involved in manufacturing are clearly defined in batch manufacturing record for individual products. All the steps will be carried out using the equipments / vessels as indicated in BMR.
- The whole procedure is documented online and signed by competent technical staff in BMR.
- All equipments are operated as per their respective SOP's for operation.
- The area also has equipments for heating and cooling wherever required. The transfer of materials is by means of creating vaccum in the receiving vessel wherever possible.
- The completed Batch is stored in a closed storage vessel. The status label of the vessel contains the following details :
Product Name, Batch Number, Batch Size, Manufacturing Date, Expiry date, Status - completed batch ready for filling, Remarks - to be sampled and checked by sign.
- Sampling of bulk products is done by Quality Control Department after receiving Test Request form from Production department.
- After getting approval for filling from the Quality Control, the product is transferred to filling line by means of reciprocating pump. The equipment is operated as per ‘SOP for Operation of Reciprocating pump’.
- The Creams/Gels / Ointments to be filled in specified tube is given in Batch Packing Record.
- Filling is done by using Tube Filling and Sealing machine. As per Batch Packing record specified weight will be filled in tubes.
The equipment is operated as per “SOP for Tube filling and Sealing machine”. The batch number details will be embossed on the tube. The detail includes Batch number, manufacturing date, expiry date and price.
- The specification and limits for packing are mentioned in the individual monograph. At frequent intervals fill volume, sealing, batch number details are checked and it is recorded in individual Batch packing record with supervisors signature.
- After final packing the product is sampled by QA and the same is analysed as per pharmacopoeial/inhouse specifications. The total yield is recorded, total process loss is calculated and entered in the batch record.
The product is warehoused and then despatched after evaluation of the Batch record from QA Department. The final product release is done after receiving batch release certificate from QA. The quantity released for ware housing is recorded in the Batch records.
- All the equipments used for the batch are cleaned as per “ SOP for cleaning of the Equipment” and status labels are fixed onto the equipments.
- All the containers and lids of Dispensed materials are washed. The containers are placed in the area reserved for their storage with status label, until they are required again.
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| Brief description of Production Operation for Mouth Wash, Liquid Gels, Liquid Oral syrups & Suspension manufacturing. |
- Materials in dirty containers or original containers of manufacturers are not received in the manufacturing area.
- It is ensured that measuring and dispensing devices such as scoops, spoons, etc do not contaminate any materials. All equipments used for handling the materials are cleaned immediately after each use.
- All materials are weighed into clean, tared and labeled containers.
The label contains name of the product, Product Batch No.,
Manufacturing date, Expiry date, Batch size, Name of the material, Analytical Report No. etc., and net Weight, dispensed by and checked by signatures.
- Dispensing is not performed in the manufacturing area, but it is carried out in a seperately designated dispensing booth by stores.
- Before commencing manufacturing process, the supervisor ensures that the manufacturing area and the equipment used for manufacturing are clean and labeled and gets the same certified in the batch production record by Quality Assurance Department.
- De-mineralised water collected by the process mentioned in the “SOP for Collection of De-mineralised water” is used for production.
For manufacturing purpose, boiled and cooled Demineralised water is used. The DM water collected in storage vessel is heated and cooled by means of plate heat exchanger.
The Demineralised water collected by this process is tested for the specifications laid down for DM water, before use.
- The required quantity of DM water is transferred from DM water storage vessel to manufacturing area by means of SS loop distribution system. This water is collected in storage vessel.
- Wherever sugar syrup is required, it is made in jacketed sugar syrup vessel which is mounted on load cell. The sugar is transferred by sugar transfer system which consists of blow airs, filter bags etc.
- The other ingredients of the product are then incorporated in the order and as per the procedure laid out in the individual monograph for each product. The stirrer/homogenizer is turned on for the period specified and the time of stirring is recorded and signed in the batch production record. The equipment is operated as per SOP.
- In case the material is to be heated and then incorporated to batch, such material is heated in steam jacketed kettle. The equipment is operated as per “SOP for operation of Steam Jacketed Kettle”.
- The product is then milled/filtered wherever required as specified in the batch manufacturing record. Colloid mill/filter press are operated as per their SOP's.
- The filtered/milled product is stored in closed containers / tanks. The container/tank is labeled with inprocess labels having the following details: Product name, Batch number, Batch size, Manufacturing date, Expiry date, Status - filtered batch, ready for filling, Remark-to be sampled and checked by Signature.
- The sampling of bulk product is done by the Quality Control Department after receiving Test Request Form from Production department.
- After getting release for filling from the Quality Control, the product is transferred to filling line. The transferring is done by using Product Transfer pump/pipes. The equipment is operated as per ‘SOP for Operation of Transfer Pump’.
- The products are filled into specified containers.
- The bottle / vials / pet bottles / PVC bottles are washed with DM water in bottle washing machine, the equipment is operated as per “SOP for operation of bottle washing machine”. The washed bottles are inspected as per SOP.
- The liquid is filled by using volumetric filling machine / 8 – Head mono block filling & sealing machine in Module II & III respectively. As per batch packing record specified volume is filled in bottles/vials/pet bottles/PVC bottles. The filling machine is operated as per “SOP for liquid filling machine”.
Bung pressing machine is employed for fixing bungs wherever required. The equipment is operated as per “SOP for operation of Bung Pressing Machine ”.
Bottles are capped by using ROPP Cap sealing machine, the equipment is operated as per “SOP for operation of Cap Sealing machine”.
- Filled bottles are inspected. The equipment is to be operated as per “SOP for operation of Inspection ”.
- Filled and inspected bottles are labeled with Product details like Batch number, Manufacturing date, Expiry date, price by using Automatic Labeling machine. The equipment is operated as per “SOP for Operation of labeling machine”.
- The specifications and limits for packing are mentioned in the individual monograph. At frequent intervals, filled bottles are checked for fill volume, bottle condition, cap sealing, labeling and it is recorded in individual batch Packing Record with Supervisor’s signature.
- After final packing the product is sampled by QA department on giving test request form. It is analyzed as per pharmacopoeial / in-house standards. The total yield is recorded and the total process loss is calculated and entered in the batch record. The product is warehoused after evaluation of the batch record from QA department. The final product release is after receiving Batch release certificate from QA The quantity released for Ware housing is recorded in the Batch record.
- All the equipments used for the batch are cleaned as per “SOP for Cleaning of the Equipments”.
- All the empty containers and lids of Dispensed materials are washed. The containers are placed in the area reserved for storage with status labels until they are required again.
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| Arrangements for Handling Raw Materials, Packing Materials. |
| Materials are received and dedusted in the dedusting room, stored and handled properly in order to avoid contamination. |
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| Status labels identifies status of the materials. As soon as the material arrives to the stores, physical condition of packing is observed, “Material received” label is put, Goods received Note is made and sent to QC department for sampling and further analysis. |
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| After sampling, QC department puts “Under Test label”. After analysis “Approved”/ “Rejected” label is put. Format for all these labels are made and details are written by hand and duly signed by concerned person. |
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| Sampling of raw materials and Packing materials is done as per the sampling plan. Sampling booth is used during sampling of raw materials. Materials are segregated as active and inactive. Actives are sampled for each and every bag/container. Inactives are sampled using the formulae square root of n + 1, where n = no. of containers. |
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| After getting approval from QC department, both raw and packing materials are dispensed. On receiving work order from QA department and after checking of work order from Production Department, dispensing activity is undertaken. |
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| Dispensing of solid raw materials is done in the dispensing booth on the basis of first in first out, first expiry. Liquid materials are dispensed in the liquid dispensing room in a similar way. Packing materials are dispensed in packing material stores. Separate area is specified for decartoning of materials. Materials are dispensed based on the quantity as in the work order. After dispensing of a particular batch, materials are kept in a staging room and informed to Production department. |
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| All raw materials dispensed are cross checked for their gross weight and counter checked with dispensing slip and work order in the Production department. |
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| All materials are segregated based on their status. All materials are placed on the racks/pallets. Handling of preprinted materials is controlled. Labels and cartons (preprinted materials) are kept in the rack under lock and key. There are 3 different areas, Yellow area for under test, Green area for approved materials and Red area for rejected materials. The areas are differentiated by respective colour bands on floor and in some areas respective coloured ropes are used. |
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| Entry to stores is restricted only to authorized persons. |
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| Material movement – Annexure IX enclosed. |
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| Arrangements for Handling Rejected Materials and Products |
| Materials and products which are labeled as Rejected are kept separately in red area meant for rejection. The rejected materials are sent back to the manufacturer or supplier, along with one copy of analytical report with appropriate reasons for rejection, based on the decision of Asst. QA Officer. |
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| Rejected packing materials returned from the Production department is collected separately and kept in separate racks painted with red coloured paint meant for the storage of rejected material. Rejected packing materials are destroyed as per the written procedures after recording in Destruction record book. All rejected materials are stored in locked cages/racks/shelves. |
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| Process Validation : |
| First three batches of all the products manufactured, of same batch size are being validated and kept for stability studies as per ICH guidelines and all the validated processes are documented. |
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| All the processes validated are recorded in the Process Validation protocols. |
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| If any active or inactive ingredients & equipments are changed, even then the process validation will be done as per written procedures and protocols. |
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