In plant project report on Incepta Pharmaceutical Ltd. Zirabo, Savar, Bangladesh

TRADELABOR has more than 20 years of experience in the control and treatment of air, working with an experienced and qualified technical staff and with the most advanced technology in this area, which together guarantee the quality of the services provided.

 

 

Warehouse:

The warehouse of Incepta is an enclosed building and protects the stored goods from environmental influences. They are secured against fire by the design of the buildings and technical facilities. They are secured against fire by the design of the buildings and technical facilities. The fire brigade facility has access to enable appropriate firefighting. The locking system of the stored goods ensures that the access to the building is controlled.

Our warehouse is equipped with four different storage conditions; a) 2oC – 8oC, b) 8oC – 15oC, c) 15oC -25oC, and d) ambient condition. There is specific quarantine and sampling areas with dedicated separate storage location for cephalosporin, and steroids. Temperature sensing is equipped with remote sensor technology.

There are controlled rooms with HVAC for specific materials and the conditions are monitored to confirm compliance with the requirements. Also there is retention sample room.

The materials are stored in the warehouse by pallet racking. The status of materials and products is controlled by colored status sticker.

The transaction of materials is done according to “first in first out” system. Accounting and storage is maintained through SAP.

The area of warehouse includes-

 

  1. Dispensing booth
  2. Storage area for

–Raw materials

–Finished products

–Packaging materials

  1. Quarantine area for

–Raw materials

–Finished products

 

  • Storage Area for Raw materials:
  • Raw material store: Goods kept when released by QC
  • Cool room: 2-8 °C
  • Dispensing room: for dispensing of ingredient.
  • Quarantine area: After receiving of raw material they are stored first in the quarantine area. If Q.C sampling and checking is approved then shifted to the store.

 

  • Storage Area for Finished Product:
    • Quarantine area: At first finished products are stored in this area for about 14 days, checked by Q.A.D, if problem arises the product should be rejected and reprocessed if possible.
    • Product ready for marketing: After “pass” from the Q.A.D finished products are shifted for marketing.

 

  • Storage Area for Packaging Materials:

In this area packing materials are stored in normal condition and in control environment. The store has well defined are for different packing materials. First the goods are kept in Quarantine area for packing materials. Some materials like alumunium foil are kept in AC store.

 

The major activities of Warehouse:

  1. Ensure the reception of right materials.
  2. Issue required materials for production within the limit.
  3. Reception of Finished Goods from production & timely distribution.
  4. Monitoring of temperature & relative humidity.
  5. Overall cleanliness of both materials & areas.
  6. Materials management (Segregation, QC formalities, Disposition, etc.)

 

Figure: Warehouse Department of Incepta Pharmaceuticals Ltd.

  1. The duties of Ware House is sequentially- (Raw Materials Receive)
Checking of vehicle with Receiving chalan/Invoice (Exact product, volume/amount)
Unloading vehicles, sorting and palletization
Cleaning of incoming materials
Checking for damage/loss/excess
Information entry inSystemic Application product in data Processing” (SAP)
Preparation of “Goods Receive Information” (GRI) & Quarantined Label
Affixing of “Quarantined Label” & transfer of materials to the quarantine area of warehouse.
Sending out of GRI to QC department
Result: Released                               Result: Reject

Affixing of release label, transfer of material to released area & sotware entry

 

Affixing of reject label & transfer of material to reject store

Informing PPIC about rejection of materials.

 

  1. The duties of Ware House is sequentially- Raw Materials issue to production
Receiving of “Batch Manufacturing Record” (BMR) from Production
 
Checking of materials “Process Order
Information entry in the required field of BMR
Arranging of required released materials as per FIFO/FEFO system
Information entry in Bin Card
Issuing materials to the materials dispensing both
Dispensing of Raw Materials & issue to production
Returning the access materials to Warehouse & information entry in “Inventory software”
Storing of returned excess materials in the respictive location/area of warehouse.

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  1. The duties of Ware House is sequentially- Finished goods dispatch
Receiving of “Requisition of Finished Goods”  from Central Sales Centre.
Checking of availability of Finished Goods
Sending request to Quality Assurance for release (if required)
Arranging covered van for loading Finished goods
Preparation of Delivery Challan, Issue voucher & gate pass
Information entry in finished Goods register as well as inventory Software.
Exit of Finished Goods Vehicle from Warehouse

 

Different Units of Warehouse:

  • Quarantine area:

After receiving of raw materials they are stored first in the quarantine area. Then Q.C. sampling and checking is approved and then shifted to the main storage area. Purpose of Quarantine area-

  • To receive the raw materials
  • To store the material before it passed the QA test
  • To manage the materials properly and systemically.
  • Sampling area:

Sampling means the process of taking a small portion from a lot for test and analysis to show the quality of the whole lot. The purpose of sampling and subsequent testing is to provide an effective check on the quality of the product or substances being processed.

  • Main storage area:

Here raw materials are stored. There is another isolated storage area for sophisticated materials maintaining temperature and humidity inside the main storage area. The storage department performs some important functions such as

  • Specific raw materials are stored in specific mentioned area with proper documentation. Cool area: 15-24°C & Humidity: 45-55%.
  • According to monthly program, this department has the responsibilities to get final Q.C. approval for raw materials.
  • According to plan and recovery maintenance, the raw materials are supplied to the production area for required batch size.
  • Dispensing area:

Here raw materials are weighing under a laminar air flow cabinet and supplied to the production areas by weighing according to the proper document and release it from the RM store. The area from where raw materials and packing materials are dispensed according to the requisition sheet for the production. Raw materials, packing materials and finished products kept in different places should be labeled properly. Only the approved (green tagged) materials are brought to the dispensing area. Materials that come first are dispensed first according to the FIFO (first in first out) rule.

  • Released area:

Here raw materials are stored, those only passed the tests performed by QC and QC provides released tag. Purpose of released area-

  • To store the approved materials
  • To store the approved materials in different conditions as specified by the manufacture.
  • Not released area:

Here raw materials are stored, those tests not yet performed by QC and QC provides not released tag.

  • Rejected area:

Rejected materials are stored here those failed the tests performed by QC and QC provides rejected tag and the local raw materials are returned to the suppliers. Imported raw materials are destroyed.

  • Special area:

It includes Cold room (Temp. 2-8, e.g. Cephradine, Cephalosporine); Cool room (Temp. 8-15); Controlled room (Temp. 15-25); Ambient room (surrounding room temp.).

  • Preservation of products:

Due to some physicochemical changes medicines are sensitive products. So, to protect the most sensitive ones, manufacturers use different techniques and adjutants. In addition, each product goes with its own preservation instructions. In the warehouse, it is essential to preserve the pharmaceutical products from the factors of degradation to guarantee their stability up to their expiration date.

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Manostaxx – Industrial Management Consulting

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