5.1 Feasibility Evaluation for New Product: 
5.1.1 Production department shall perform feasibility evaluation for all the new products, intended to be introduced into facility, in coordination with all cross functions departments like-R&D, QC, QA and other concerned departments.
5.1.2 R & D / Customer shall fill the product information checklist before execution of new product at site.
5.1.3 Following attributes shall be considered during the feasibility evaluation, but not limited to:
5.1.3.1 Feasibility for manufacture of the proposed product, at site.
5.1.3.2 Adequacy of existing infrastructure for manufacture & testing of proposed product.
5.1.3.3 Any additional requirement of capital items or enhancement of infrastructure capabilities.
5.1.3.4 Requirement of any special permission from relevant regulatory authorities for the proposed product.
5.1.3.5 Requirement of Environment, Health & Safety aspects.
5.2 Pre-Requisites for feasibility / scale-Up / pre-exhibit / submission batches:
5.2.1 Based on the requirement, develop a product by taking necessary lab scale trials and finalize the process.
5.2.2 Manufacturing of any product in the facility typically start with feasibility / scale-up / pre-exhibit batches and/ or exhibit/submission batches, followed by commercial scale batches, after due registration/ approval by respective regulatory agencies.
5.2.3 AFD / Contract customers develop applicable analytical methods and perform method validations. The validated methods shall be transferred to plant QC by AFD, before start of scale-up or exhibit / submission batch.
5.2.4 FDD/Contract customers shall prepare the material specifications and shall share BOM to plant production department for initiation of procurement.
5.2.5 Procurement shall be carried out after approval of applicable documents & vendors by QA, in coordination with production and planning departments.
5.2.6 Planning and Purchase departments shall ensure the availability of materials at plant, as per the plan of feasibility / scale up / pre-exhibit or exhibit / submission batches.
5.2.7 New product execution checklist shall be circulated by QA to all relevant departments for comments
5.3 Execution of feasibility / scale-up / pre-exhibit batches:
5.3.1 After readiness of all the pre-requisites and duly completed new product execution checklist by the all-respective department, production shall plan for manufacture of feasibility / scale-up / pre-exhibit batches in coordination with QA as per the requirements of R&D.
5.3.2 QA shall prepared feasibility / scale up / pre-exhibit protocol for batch execution.
5.3.3 TTD/Production shall prepare the feasibility / scale up / pre-exhibit batch manufacturing and packing record for execution of manufacturing and packing activity.
5.3.4 Materials being used for feasibility / scale-up / pre-exhibit batches shall be tested by AFD / QC for minimum requirements of the specifications.
5.3.5 All the required information shall be filled in the new product execution checklist by respective departments. The same shall be evaluated by QA, for its completeness, adequacy, and clearance for execution of feasibility / scale-up / pre-exhibit batches.
5.3.6 The plant QA & Production departments shall ensure the required procedures / records, i.e. SOPs, Batch Records, Logbooks, Protocols etc., are available prior to start of execution.
5.3.7 Training shall be provided to plant personnel on specific product / operational attributes by FDD, before execution of batches, wherever applicable.
5.3.8 The feasibility / scale-up / pre-exhibit batches shall be executed by production, under direct supervision of FDD, as per the instruction of respective batch record/ protocol and procedures. IPQA will monitor the activity as per the procedures, wherever applicable.
5.3.9 All the activities shall be documented in respective records / logbooks, concurrently during the execution.
5.3.10 Cleaning validation protocol shall be prepared by QA as per the requirements of cleaning validation SOP, wherever applicable. The relevant samples shall be tested to verify the adequacy of cleaning processes, as per the protocol/ procedure, as applicable.
5.3.11 After manufacturing of feasibility / scale-up / pre-exhibit batches, Production & QA shall ensure that the area is clear from all the materials with necessary clean up and documentation.
5.3.12 All the units produced in the feasibility / scale-up / pre-exhibit batches, required quantity shall be submitted to plant QC department for stability studies (if applicable) and remaining quantity shall be hand over to FDD for subsequent evaluation at their end or shall be transferred to warehouse for future reference till complete testing and availability of adequate data.
5.3.13 After complete execution of feasibility / scale-up / pre-exhibit batches and quality control analysis, QA/TTD should prepare the report for evaluation and conclusion.
5.3.14 QA/TTD shall submit the final feasibility / scale up / pre-exhibit batch report to FDD for adequacy of the process parameters and quality attributes.
5.4 Execution of exhibit / submission batches:
5.4.1 After readiness of all the pre-requisites, production shall plan for manufacture of exhibit / submission batches in coordination with relevant cross functional departments of the plant and R &D/Contract customers
5.4.2 Before start of exhibit batches, check and verify the availability of following attributes to in line with established quality system requirements but not limited to;
5.4.2.1 Technology Transfer Dossier
5.4.2.2 All applicable regulatory permissions and product licenses.
5.4.2.3 Approved specifications and testing procedures at plant for all the starting materials/ product with other analytical resources (i.e. standards, columns, qualified analysts etc.).
5.4.2.4 Qualified facility, utilities and equipment’s and environments.
5.4.2.5 Approved SOPs to carry out all the activities of manufacturing & testing, with required personnel training.
5.4.2.6 Starting Materials released by quality controls, as per the approved specifications.
5.4.3 QA shall initiate the new product execution checklist and forward to all the applicable departments for the required information.
5.4.4 Production department shall prepare BMR/BPR, based on the guidance of MMFC, MPC and as per respective SOP.
5.4.5 QA shall prepare process validation and cleaning validation/verification protocol as per respective SOPs, wherever applicable.
5.4.6 All the required information shall be filled in new product execution check list by respective departments. The same shall be evaluated by QA, for its completeness & adequacy, the check list as a clearance for execution of submission batches.
5.4.7 The batch records & protocols shall be issued by QA to production department for execution purpose.
5.4.8 R&D / TTD department shall provide the training to all concerned personnel at site before execution of exhibit batch.
5.4.9 The submission batches shall be executed by production in presence of R&D / TTD as per the instruction of respective batch records/ procedures. QA shall monitor the activities as per the SOP and batch record instructions.
5.4.10 All the activities shall be documented in respective records/ logbooks, concurrently during the execution.
5.4.11 All required samples shall be collected and extensive testing shall be performed on submission batches as per the BMR & protocols / sampling plan, to validate cleaning practices and process attributes adequately.
5.4.12 QA should compile all the data and conclude the validations/ verifications, as applicable, which shall be used for submission purpose.
5.4.13 Closure of activities & reconciliations shall be performed at relevant stages by production & QA, as per the instructions of BMR & SOPs.
5.4.14 The exhibit / submission batch sample shall be reserved till one year after the ANDA/Marketing authorization approval.
5.5 Execution of Commercial Batches:
5.5.1 Commercial batches manufacturing shall be driven through marketing/ business requirements.
5.5.2 All the operations shall be performed as per the licensure/ registration requirements, after due approval from respective regulatory agencies.
5.5.3 QA shall initiate “Check List for Prerequisite Commercial Batches and forward to all the applicable departments for the required information.
5.5.4 Production department shall prepare BMR/ BPR, based on the established/ validated processes during the manufacture of submission batches and/ or other relevant information by FDD/ Customer.
5.5.5 Validation group shall prepare process validation and / or cleaning validation protocols as per respective SOPs, wherever applicable.
5.5.6 All the required information shall be filled in the “Check List for Prerequisite Commercial Batches” by respective departments. The same shall be evaluated by QA, for its completion & adequacy shall be approved by enclosing the check list & execution plan as clearance for execution of commercial batch.
5.5.7 The batch records & protocols for the commercial batch shall be issued by QA to production for execution purpose.
5.5.8 The commercial batches shall be executed by production with direct oversight of Quality Assurance, as per the instruction of respective batch records/ procedures.
5.5.9 All the activities shall be documented in respective records/ logbooks, concurrently during the execution.
5.5.10 The batches shall be disposed / released into market as per the established quality system procedures and respective regulatory/ customer requirements/ commitments by QA.