To lay down a procedure for product change over in modules and primary packing areas.
Module 1,2,3 and primary packing areas.
Executive / Sr. Executive - Production
5.1 The term “ product change over” denotes whenever an another product is to be taken for manufacturing, primary packing in an area / equipment which were used for the other product.
5.2 Remove the previous product and all accessories like punches and dies, FBD bags, FBD bowl covers from the module and transfer them to the quarantine area.
5.3 Arrange for cleaning of equipments for product to product changeover as per the respective SOP’s.
5.4 Send T.I sheet to QC through QA for swab sampling and analysis.
Note: (For the products where cleaning validation is not completed.)
5.5 Ensure that all the equipments are cleaned.
5.6 Arrange for cleaning of all the process areas by house keeping department as per SOP and ensure that cleaning is completed and recorded.
5.7 Send the communication note to engineering dept for AHU filter cleaned. Ensure the cleaning of module AHU’s by maintenance department.
5.8 Check thoroughly throughout the module for area cleanliness and ensure that no traces of the previous product is left over, status label and documents are removed from the areas.
5.9 Get the analytical results of the swab test (if applicable) and enclose with BMR of next product.
5.10 Ensure that clean secondary dresses and gloves are kept in gowning room for use, after the gowning room is cleaned.
5.11 Enclose the AHU cleaning confirmation note in the BMR of next product.
Primary Packing Areas.
1. Remove items and documents / labels of the previous product and accessories like change parts, and stereos.
2. Remove primary packing materials like foils and PVC film from the area and transfer them to the respective quarantine with required status labels.
3. Arrange for cleaning of the machinery for product to product change over as per respective SOP’s and ensure the cleaning is completed and recorded, get the tool box cleaned.
4. Send T.I. Sheet to QC through QA for swab sampling (if applicable) and analysis.
5. Arrange for cleaning of the area by House Keeping department and ensure that cleaning is completed.
6. Check thoroughly the areas and equipment for cleanliness and ensure that no material and documents / labels of the previous product is left over.
7. Get analytical result of the swab test and enclose the same with BPR of the next product.
8. Ensure that cleaned secondary dresses and gloves are kept in the gowning room for use, after the gowning room is cleaned. Put the clean status label on all equipment after cleaning.