Contract Manufacturing, Purpose:
Contract Manufacturing, To establish a procedure that XX products are manufactured by the contractor using facilities and operations and to ensure that all batches of product manufactured at third party contract manufacturer that conforms to cGMP requirements undergo a formal evaluation of suitability for use prior to release to the market.
Contract Manufacturing, Scope:
The SOP is applicable for all products of XX Pharmaceuticals Limited manufactured & packed by a third party contract manufacturer.
Definitions / Abbreviation:
[][]QA – Quality Assurance
[][]QC – Quality Control
[][]QA – Quality Assurance
[][]BMR – Batch Manufacturing Record
[][]BPR – Batch Packaging Record
[][]ERP – Enterprise resource planning.
[][]cGMP – Current Good Manufacturing Practice
[][]COA – Certificate of Analysis
Responsibilities:
[][]The roles and responsibility is as follows:
Third party contractor
[][]To perform all the manufacturing related activities, analysis of the manufactured & packed product as per the contract/ toll manufacturing agreement
Executive, Production
[][]To check and review the production related activities.
Executive, Warehouse
[][]To supply and update the required raw and packaging materials as per forecast
Executive, QA
[][]To verify the overall manufacturing activities, collection of sample and related documents
General Manager, Plant
[][]Proper follow-up of overall activities
Manager, Quality Assurance
[][]Approval of all the toll manufacturing activities.
Procedure:
Selection of Third Party/ Contract Manufacturer
[][]Carry out GMP audit to assess the prospective contractor’s technical capability, capacity, cost effectiveness & the capability to maintain the required standards of cGMP & product quality.
[][]Document the business objectives and the justification for selecting a third party contractor.
[][]Review the manufacturing strategy which will be applied to the third party contractors.
[][]After developing a third party contract manufacturer, provide the product and their volume to the third party contractor for its technical assessment of manufacturing capability.
[][]Multiple strategies to be followed in selecting third party contractor.
[][]Consider the sources of materials which must meet the approved specification.
[][]Sign a contract manufacturing agreement with the selected contractor for manufacturing / packaging of products which will be followed accordingly.
[][]XX personnel will generate all the relevant documents as per contract manufacturer’s requirements for batch production.
[][]Production Executive will supply a production forecast of the required quantities of each product two months in advance so as to consider in third party’s
[][]production plan. XX shall have the right to revise the forecast in accordance with the market situation informing contractors one and half month in advance.
[][]Warehouse personnel of contract manufacturer will generate a month wise stock statement for raw and packaging materials to XX.
[][]Production Executive will generate the batch no. as per production forecast to Quality Assurance Executive along with requisition copy for BMR & BPR.
[][] QA Executive will issue the photocopy of BMR & BPR to Production Executive for manufacturing by third party. Master copy of all documents will be preserved at QA end.
[][]For testing procedure of raw and packaging materials will be followed as per contract manufacturing agreement. If any material (Raw/ Packaging) which will be tested by third party, will be forwarded by QC Executive from QUARANTINED stage along with forwarding letter to the contractor.
[][]After receiving the test report from third party, QC personnel will disposition the materials as PASSED/ REJECTED following the SOP.
[][]Production Executive along with warehouse Executive will supply all the materials to third party following the production forecast as per requirement within first week of running month. During supply of materials warehouse executive to be ensured the status label as per requirement by third party.
[][]Contract manufacturer will follow their production schedule and manufacturing operation will be started at the presence of Production and QA personnel of XX.
[][]XX personnel will verify all the written instruction in the BMR & BPR following the third party’s SOP as per cGMP requirement.
[][]All the in-process checks (IPC) will be conducted by contract manufacturer along with XX personnel.
[][]In case of any process validation activities will be conducted by XX personnel using the facility of third party.
[][]For testing of bulk intermediate and finished product, responsibility will be performed by XX and contract manufacturer as per contract manufacturing agreement.
[][]Sample for in-process check, chemical test and microbial test will be withdrawn as per agreement policy following the SOP of XX or contract manufacturer. [][]Finished product samples will be withdrawn as per same requirement.
[][]Retention sample will be kept at contract manufacturer’s end. If the retention sample is required for XX, then the sample will be forwarded to XX end by contract manufacturer following their own policy.
[][]Stability sample will be withdrawn from packaging line as per stability protocol and to be forwarded by contract manufacturer to XX end.
[][]If the stability test will be performed by contract manufacturer, samples will be kept in the manufacturer’s end as per protocol. In that cases test report will be forwarded to XX end accordingly. After receiving all the stability data, QA Executive will prepare the stability report.
[][]Third party contract manufacturer’s site will provide XX personnel with full batch documentation, copies of any unplanned event or deviation (including OOS), a copy of any investigation reports and COA reporting analytical test results against specification.
[][]QA and production personnel will review all the batch documents along with supportive records as per checklist for batch documentation after prior release from contract manufacturer.
[][]Original batch document or photocopy of the original will be provided by the contract manufacturer to XX end.
[][]Production personnel will issue the used quantity of raw and packaging materials in the ERP software with the help of IT personnel according to batch production record to update the material status.
[][]After reviewing the batch document, Production and QA representative will send the notification to the third party contract manufacturer about the batch disposition decision.
[][]Upon receiving the batch disposition decision from XX Pharmaceuticals Limited, the third party contract manufacturer will take step accordingly.
[][]XX shall take delivery of the finished products in XX’s own liabilities within fifteen days of intimation by contract manufacturer that the product is ready for dispatch.
[][]After completion of cost related process by both XX and contract manufacturer, central warehouse will receive the finished product and kept in the central warehouse of XX as per storage condition.
Annexure:
None