User guide for pharmaceutical suppliers

Transcription

1 Drug supplier database pharmaqc User guide for pharmaceutical suppliers Updated March 2011 The drug quality assurance database pharmaqc has been developed for pharmaceutical suppliers to the NHS, for QC Pharmacists, NHS trust pharmacy staff and NHS Commercial Medicines Unit category specialists. Pharmaceutical suppliers enter details of their individual products offered for tender on our website such that QC Pharmacists can then quality assess, and search across all supplier products using a separate, secure website and category specialists can assess more effectively supply chain risks by reviewing data such as manufacturing and raw material scope. This product has been developed to streamline the contractually required process (i.e. existing QA process) to help with the once-only principle across Government. A summary of all product data required can be accessed and printed off once you have logged onto the system. 1

2 Accessing the system The drug supplier database can be accessed at: Pharmaceutical suppliers have been pre-registered on the system and have received notification of their account details. When entering the system the first screen you will see will prompt you to login as follows: Suppliers should note that they may only view their own company details. All company/product details are then made available to QC Pharmacists and NHS Commercial Medicines Unit category specialists using the secure extranet, known as the NHSnet, with the additional security of a member login facility. 2

3 Selecting the products your company is able to supply After you login, you are presented with the allproducts screen use any or all of the boxes to search the full database in order to assign this product to your company database e.g. Name ascorbic acid : If the product CAN be identified from this list (from the full database) click on the tick on the right hand side to add the product (to your company database): If the product in the particular form/pack/strength size you have specified is NOT displayed, or there are no results shown, this screen is displayed: 3

4 Creation of new product details Follow the instructions at the bottom of the screen to request for the new product in the particular form/pack/strength size you have requested to be created by the database administrator. For a completely new product a new NPC code will be allocated by the database administrator. The database administrator will need to facilitate the creation of new products in the particular form/pack/strength size you have requested on a supplier s behalf. The database administrator will contact you within five working days to advise when your request has been processed. This may mean there is a short delay before you can continue to the next process in the database for this particular product. Adding product details on myproducts screen In order to ensure that you have all the necessary information to hand before you start you can click on Summary of all data required to complete form. Once the product has been identified using the search facility, in the required combination of form/strength/pack size - and having ticked the box to add this to your company s set of myproducts - you will need to enter full details of the product selected. 4

5 This will involve data entry on two screens click the >>Next button to move from the first to the second screen. Please ensure you complete all mandatory fields (indicated by an asterisk). You will need to complete a minimum of one manufacturer and one raw materials supplier details. Screen one product details Screen one (continued) 5

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7 Screen two pack details Notes At least ONE of the licence numbers parallel import or UK product or EMEA licence numbers - must be completed; if UK licence number has been given then Licence approval date must also be completed. If you answer yes to Expiry date, Date of manufacture or Batch number, you must indicate whether this information is Printed or Embossed. In summary, we have logged into the pharmaqc system, selected a product type from the full database, assigned this over to my set of products and in the process, added manufacturer/raw materials/licence/pack details. Now you can select myproducts to view all the products you have entered details for. 7

8 To add further products to your assigned products i.e. myproducts, click on allproducts to continue to search the full database. To add additional pack sizes for a product whose details you have already entered into myproducts, go to myproducts and click on the green tick against the existing product line. Here you will find a screen that contains the details for the original pack and allows you to add information for further packs. You may choose the manufacturer and raw materials supplier for the original pack from the drop down list, or click on the link add another manufacturer/raw materials supplier to set up another. An option to display a summary of the product details is available from this screen this displays in a pop up window. If you wish to have a complete list of your products, click myproducts, scroll to the foot of the list on screen and click Show report. At the foot of the next screen click me this report. 8

9 Uploading images PharmaQC database has been upgraded to allow suppliers to post a maximum of 6 graphic images of each their products on to the system. This can be done when adding details for a new product or modifying a product. Please ensure that the images submitted are to the following specification: o for speed of communication the NHS Commercial Medicines Unit recommends that the size of any particular image does not exceed 1 MB which is the size of the full colour image made with a digital camera of up to 3 megapixels. This gives a high quality image o types of file that can be stored cover any of the standard graphical/postscript file formats jpg, gif, pdf Of the six images that can be uploaded for each product, suppliers are asked to provide: Image 1 - products packed in cartons and bottles and securitainers The image should be of the complete carton with the contents laid to the right hand side, specifically. o ampoules - the inner ampoule holder should be shown with one or more ampoules removed and placed in front. 9

10 o blister or foil packed unit doses - both sides of the blister or equivalent should be shown with one or two doses removed and placed in front 10

11 o bottles/securitainers - the image should be of the container. If the container is individually packed in a carton then this should be shown to the side of the container. If the container contains unit doses e.g. tablets, one or two doses should be removed and placed in front. 11

12 Image 2 secondary packaging The image should be of appropriate artwork or the carton opened out to show all six sides Image 3 - label The image should be of label artwork (e.g. ampoule label) [sample image not available] Image 4 product range The image should present appropriate product ranges (see next page) 12

13 Image 5 Summary of Product Characteristics (SPC) Image 6 extended stability data (where applicable) To attach an image click on the Attach image(s) button at the foot of the pack section of the Add details screen. A new window will appear where you can browse to the image you wish to attach by clicking the Browse button. NB the file name should not include spaces or any of the following characters:. % + & # Once you have selected an image please type a description for the image in the Description box, for example Primary packaging ; Secondary packaging ; Primary and secondary packaging. Once these details have been added click the Submit button, this will ensure that the information is added into the original screen from where you clicked the Attach button. Any images submitted to the NHS Commercial Medicines Unit prior to 30 June 2006 will have been stored against NHS access to PharmaQC and will not be visible to suppliers. These images should be added by suppliers. Suppliers who have populated PharmaQC with product information prior to 30 June 2006 may find dummy entries for their products. NHS Commercial Medicines Unit has created these entries to enable us to post previously received images and QC assessment. When suppliers encounter dummy entries you should add/amend the information as appropriate. NB data 13

14 should be added both for products on contract and where bids have been submitted for tender, or pre-tender samples submitted. Suppliers can delete images. In the My products list click on the View image(s) icon next to the product. Then click on the red cross above the image to delete it. NB Although you will no longer be able to view the image, it will be marked as Archived and remain visible to QC pharmacists and NHS CMU staff. If you have uploaded the image in error and wish it to be removed entirely please contact us details below. For further advice and assistance if you encounter problems please contact the pharmaqc database administrator details below. Contact us Please contact the pharmaqc database administrator at or phone on