1.0 Purpose
1.1 To adequately specify the procedures for development of a newly identified product and its packaging components with the involvement of relevant persons and departments.
2.0 Scope
2.1 This Sop is applicable for all new formulation development projects at "NAME" Pharmaceuticals Ltd.
3.0 Responsibility
3.1 A team consisting of Head of Marketing, Plant Head, Head of Production, Head of QA, Head of QC, Head of PD, Head of Engineering, Head of Supply Chain and Head of Regulatory Affairs are responsible to execute the SOP.
4.0 Abbreviations and Definitions
4.1 SOP= Standard Operating Procedure
4.2 QA= Quality Assurance
4.3 PD= Product Development
4.4 QC= Quality Control
4.5 DRA= Drug Regulated Affairs
4.6 MSDS= Material Safety Data Sheet
4.7 GMP= Good Manufacturing Practices
4.8 MI= Manufacturing Instruction
4.9 PI= Packaging Instruction
4.10 BMR= Batch Manufacturing Record
4.11 BPR= Batch Packaging Record
4.12 PDC= Product Development Committee
4.13 PIC=Pharmaceutical Inspection Convention
4.14 PIC/S= Pharmaceuticals Inspection Co-operation Scheme
5.0 Materials and Equipment
5.1 Not Appreciable
6.0 Precaution / Health and Safety Considerations
6.1 Not Appreciable
7.0 Procedure
7.1 Head of Marketing will assess customers need and identify the product. He will send Product Proposal and Product brief to Product Development Department.
7.2 He will monitor overall activities, related to development of new products.
7.3 Head of Product Development will check availability of facilities and equipment's, manufacturing tools, packaging tools. If investment is required, he will check feasibility of investment by discussing in meeting of Product launch Committee.
7.3.1 A Product Development Committee (PDC) has formed as under follows:
General Manager (Sales & Marketing)------------------------------- Convener
Head of Production Department / Head of Plant------------------ Member Secretary
Head of Quality Assurance Department---------------------------------- Member
Head of Product Development Department------------------------- Member
Head of Product Management Department------------------------- Member
7.3.2 The core responsibilities of this committee are:
7.3.2.1 To arrange PDC meeting preferably in 1st week of every month at plant / Head Office to make all technical decisions.
7.3.2.2 To fix-up target date for availability of specimen sample for QC test & PD trial.
7.3.2.3 To fix-up target date for development & finalization of art work.
7.3.2.4 To fix-up target date for availability of any change parts of blister machine (if any).
7.3.2.5 To fix-up target date for supply of RM & PM for commercial production.
7.3.2.6 To fix-up target date of product launching.
7.3.2.7 To execute & follow-up whole process from product proposal brief to launching.
7.4 He will arrange recipe and send to Regulatory Affairs Department for submission to Drugs Administration for approval. He will determine the primary packaging material.
7.5 Head of Supply Chain (Sourcing) will arrange samples of raw materials for initial source approval.
7.6 Head of Product Development will raise requisition for manufacturing tools, packaging tools etc. if required.
7.7 Head of Engineering will create facilities and arrange for manufacturing tools, packaging tools as per requirement.
7.8 Head of Product Development will arrange the analysis of raw materials and primary packaging samples. He will inform Supply Chain about the results. He will ask for more raw materials from the initially approved source required to prepare Product Development Lab batches.
7.9 Head of Supply Chain will arrange raw and primary packaging materials for Product Development Lab batches preparation as per SOP.
7.10 He will arrange initial tests and verify results with approved specification.
7.11 He will arrange to keep samples for stability studies as per protocol. Selection of primary packaging will be done based on light and moisture sensitivity of the raw materials/ product for compendia products. In case of non-pharmacopeia raw materials/ product primary packaging will be selected base on information regarding light & moisture sensitivity from MSDS supplied by the manufacturer. Innovator product may be assessed for selection of primary packaging material will be finalized after stability of the product.
7.12 For non-compendia products he will arrange samples for Drug Testing Laboratory (DTL) and send to Regulatory Affairs Department for submission to Drugs Administration.
7.13 He will inform Supply Chain management about the results of stability studies.
7.14 He will forward stability data and Annexure to Regulatory Affairs Department for submission to Drugs Administration.
7.15 Head of Regulatory Affairs will apply to Drugs Administration for inclusion.
7.16 Head of Marketing will arrange development of the packaging materials.
7.17 Head of PD will send product Data Sheet to QA for distribution.
7.18 Head of Supply Chain (Sourcing) will arrange procurement of raw materials, packaging materials and machine change parts (If required) for commercial production.
7.19 Head of Product Development will arrange necessary documents related to manufacturing and analysis.
7.20 Head of Product Development will arrange Process Validation Protocol.
7.21 Head of Quality Control will arrange analysis and release of raw materials and packaging materials.
7.22 Head of Product Development & Head of Production will arrange manufacturing of validation batches.
7.23 Head of product Development & Quality Control department will arrange physical, chemical and microbial tests for the collected samples as per the validation protocol and compare with the product specification.
7.24 Head of Product Development will keep samples from the validation batches for stability studies as per the protocol.
7.25 Head of Quality Control will review the batch history including in-process control and approve for distribution as commercial batch.
7.26 Head of Production will send samples (for compendia products) in Regulatory Affairs Department for submission to Drugs Administration.
7.27 Head of Product Development will arrange process Validation report after completion of three (03) consecutive successful validation batches.
7.28 Head of Product Development will arrange 2nd version of BMR, BPR, MI, PI & Data sheet for commercial batches.
8.0 Reference Document
8.1 WHO Guidelines, volume 2, second edition.
8.2 TGA guidelines
8.3 PIC/S guidelines
9.0 Annexure
9.1 Annexure-I : Flow Chart of New Product Development .
10.0 Revision History
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Revision No. |
Brief
reason for the revision |
Effective Date |
Remarks |
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01 |
New |
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02 |
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