SOP for ANDA Submission Batches Manufacturing Process for Tablets
1.0 OBJECTIVE:
To lay down the procedure for ANDA Submission Batches Manufacturing Process for Tablets at [Company Name]
2.0 SCOPE:
This procedure is applicable for ANDA Submission Batches Manufacturing Process for Tablets at [Company name].
3.0 RESPONSIBILITY:
3.1 Regulatory Department:
3.1.1 To guide the regulatory requirements for ANDA batches manufacturing.
3.2 Research and Development (R&D) Department
3.2.1 Preparation of Master Development Manufacturing Document (MDM) in consultation with other department.
3.2.2 Making development batch and reporting.
3.2.3 Guide in manufacturing of ANDA batches and finalization of MDM.
3.3 Quality Control (QC) Department
3.3.1 Support in analysis of samples of Raw Material / Packing Material / Finished Goods / Intermediate etc., preparation, review of analytical records.
3.4 Quality Assurance (QA) Department
3.4.1 Co-ordinate total ANDA manufacturing activities.
3.4.2 Approval and compliance of Protocols and reports.
4.0 PROCEDURE:
4.1 MDM received by QA department from R & D department which is prepared based on development batches along with development report for the product.
4.2 Similarly Bill of Material (BOM), Technical Analytical Document (TAD), Master Development Manufacturing Document (MDM) and specifications along with vendor docket (if any) is received by QA department.
4.3 QC department will check the specification, TAD in line with requirements like reagents, chemicals, instruments etc. and arrange accordingly.
4.4 Technology transfer for analytical method is carried out by Analytical Research Development Laboratory (ARDL) in predefined protocol of ARDL.
4.5 Simultaneously tablet department and QA department jointly involve in preparing Batch Manufacturing Record (BMR) on basis of Master Manufacturing Document (MDM) and BOM after checking adequacy of manufacturing equipment in connection to the batch size.
4.6 Production head arrange the production requirements like punches and dies, Filter bags etc.
4.7 All material are analyzed according to specification and taken for manufacturing of ANDA batches after QC release.
4.8 For manufacturing ANDA batches, optimization process to be followed based on development batches. The protocols for optimization batches are prepared by QA department.
4.8.1 Optimization of process based on process parameter targeted in development batches and facility at site.
4.8.2 During optimization, optimize various process parameters to qualify the product parameter. (e.g. mixing time is fixed on basis of various phases uniformity of Dosage unit. The LOD is targeted to know effect on other product parameters.)
4.8.3 To identify the lowest relative standard deviation in targeted location samples at various speed and timings are collected and analyzed for the potency. These records are summarized in protocol for optimization.
4.8.4 Total optimization process is followed as per the process flow chart given in Annexure – I.
4.9 During optimization process, IPQA fill the protocol on line and QC provides the analytical data. On the basis of this information obtained, QA person will compile the optimization report & prepare a summary report.
4.10 During qualification batch the parameters optimized in optimization batch are to be targeted for qualification e.g. Timing of mixing optimized on lowest RSD value and are qualified over here. Similarly other optimized parameters are targeted for qualifying at this stage.
4.10.1 QA person will prepare qualification batch protocol. On the basis of results obtained during optimization batch. QA person compiles the report on basis of analysis results provided by QC after qualification batch. Refer the process flow diagram as per Annexure – II.
4.11 Based on summary report of qualification batch QA person raise the Change Control Proposal for changing the process parameter in MDM and specifications (if any).
4.11.1 According to app roved CCP the TAD, MDM are, revised. On the basis of revised TAD, MDM the BMR is to be revised by production person in consultation with QA person.
4.11.2 Protocol for exhibit batch is prepared by QA person targeting same process parameter qualified at qualification batch and accordingly the analysis of related samples shall be analyzed by QC department.
4.11.3 Exhibit batch data results/ report compilation shall be done by QA person at the end of batch. The summary of the same shall be prepared. Refer Annexure – III.
5.0 ANNEXURE
Annexure-I Process Flow Diagram for Optimization Batch
Annexure-II Process Flow Diagram for Qualification Batch
Annexure-III Total Process Flow Diagram
Annexure-I Process Flow Diagram for Optimization Batch
Annexure-II Process Flow Diagram for Qualification Batch
