SOP for Product Development Process

Purpose

This SOP describes the procedure for the product development process.

Scope

This Standard Operating Procedure applies to all pharmaceutical formulation plants of the Pharmaceutical Company.

Responsibility

• Head, clinical research: Conduct clinical trials as per the good clinical practices and review and compilation of data for DCGI permission.
• Head, RA: Compilation of data for the application for manufacturing License and applying for manufacturing License.
• Head, Materials Managements: Arrangement of Raw Materials, Machine change parts for product development & initiation of vendor approval.
• Head, Production: Ensuring availability of machine change parts and facility arrangement for manufacturing of new product and if required assistance in purchasing of the new machine, training of existing / new production personnel related to new product manufacturing process.
• Head, QA: Vendor approval, artwork approval, distribution of all required documents to the concerned department for the launch of the product, review of stability data, review of product development report, product specification report, scale-up batches report & also a review of analytical method validations and qualification data of new equipment.
• Head, QA and Market Research: To provide New Product details & requirements to R&D.
• Head, R&D: Initiation of product development at laboratory scale.
• All Heads: Responsible for compliance to the procedure and continuous sending of the updated current status of Products under development to QA.

Procedure

• New Product Development Process shall be handled in phases. All the phases shall be executed simultaneously or sequentially as per requirement during the new product design/development process.

Phase I: Product Development Process

• Designee-FRD, Asst. Manager/ Manager – FRD, Head-Quality Assurance, Head of business development and HOD- analytical development lab shall discuss conceptually new product development status at the FRD in the PDP meetings. All the member shall contribute their suggestion for the development process and plan the strategy to launch the product.
• The PDP team shall discuss conceptually the new product(s) development status. All the committee members shall contribute their suggestions for the development of a new product and plan the strategy to launch the product(s). Based on the discussions respective marketing head shall identify the products under development or shall suggest the New Products’ requirements as per the market needs.

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Phase II: Product Development Process

• Head of Business Development and Asst. Manager/Manager – FRD initiates the product initiation form in coordination with the respective department head and fulfills all the details mentioned in the product initiation form.
• Depending on the product requirement Designee – FRD shall do some Literature search and market samples (If available) for references.
• Asst. Manager/ Manager – FRD shall ensure the availability of the material for feasibility trial if not available then raise the material indent in available software in the company.
• Head, QA (M) & Market Research shall assign New Product Development Number having nine characters as 

NPDXXX/YY

where

NPD: Stands for New Product Development
XXX: Denotes a serial number of the request starting from 001 to 999.
YY: Denotes respective year of the request. A new series shall commence at the beginning of every calendar year.

E.g.: A fifth request for the new product development for the year 2016 shall be numbered as NPD005/16.

• Head, QA& Market Research shall forward the filled ‘product initiation form’ to the Head-R&D. If required Head, QA- Market Research shall provide innovator/reference product available in the market to the R&D.

Phase III: Product Development Process

• Head FRD shall undergo all of the details of the identified product stated in the product initiation form and shall proceed for the feasibility trial of the product at the laboratory scale and record the activity.
• FRD and packaging development personnel shall develop specs of raw and packaging substances respectively required for the product. At the identical time, the ADL department shall develop STP for raw and packaging materials.
• Head FRD shall raise the requisition for raw/packaging materials and machine change part if required as per user specification and forwarded it to material management.
• Materials Management shall procure the raw/packaging material and machine change parts if required as per the specifications provided by the FRD. Head, Materials Management shall also arrange for raw / packaging material with the manufacturer's COA and MSDS and reference Standards.
• Material management consecutively shall initiate vendor approval.
• Head, FRD shall finalize composition, label claim, tentative production method, finished Product specification after the availability of the specified raw and packaging material and machine change components, and initiate preparation of Laboratory Pilot Scale Batches of a brand new product.
• Upon successful completion of Laboratory Scale batches of new products, a Product Development Report shall be generated by Head-FRD along with a Product Specification Report.
• Each Product Development Report shall be numbered by FRD having nine characters as 

PDRXXX/YY 

where

PDR: Stands for Product Development Report

XXX: Denotes serial number starting from 001 to 999.

YY: Respective year

• Each Product Specification Report shall be numbered by FRD having nine characters as 

PSRXXX/YY 

where

PSR: Stands for Product Specification Report

XXX: Denotes serial numbers starting from 001 to 999.

YY: Respective year.

• At the same time, Head-ARD shall start the development of the STP for in-process material & finished products and data on the stability-indicating method. The analytical method development data shall be submitted by Head, ARD to Head-QA for review.
• Head – FRD shall arrange for the stability testing for the product developed at a laboratory pilot scale. A stability data shall be generated after an accelerated study of at least three months by analyzing stability samples and maintaining the record in the stability register.
• In case any pilot batch is failed in the manufacturing process/testing, therefore, destruct the product as per the system and maintain the record in the destruction record register.
• The PDR, PSR, and accelerated stability study data shall be provided by R&D to QA for review.
• QA shall prepare a New Product Launch Activity Chart and shall update it as and when QA gets any information regarding New Product Development from the respective department.
• The updated status of new product development shall be circulated by QA to concerned departments of NPDC through NPLAC as per the requirement.
• After the successful completion of laboratory pilot-scale batches of identified/selected new product at laboratory scale, Head-FRD shall provide the following required data to Head-RA for application of the manufacturing license.

1. Label
2. Composition
3. Brief Manufacturing process
4. Raw material and Finished Product specifications/STPs
5. Certificate of Analysis
6. Stability data – minimum 3 months of accelerated stability studies, Dissolution Profile, etc.

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Phase IV: Product Development Process

• NPDC shall decide whether the new product shall be manufactured In-House or Contract Manufacturing.
• RA department shall apply for DCGI permission for the manufacturing after receiving data from FRD.
• Simultaneously QA in conjunction with Materials Management shall start the process to approve the Vendor(s) for the Raw materials as well as Packaging.

Phase V: Product Development Process 

• The samples for the clinical trial shall be manufactured by the R&D. It shall be ensured that these batches are manufactured in the cGMP facility approved by the drug regulatory authority. The same samples shall be delivered to the Head-Clinical Research for the conduction of the clinical trial.
• The stability studies as per the requirement shall be conducted for clinical trial batches.
• Head, Clinical Research shall arrange for clinical trials as per the Good Clinical Practices or available SOP's and compilation of all the data.
• If required, an on-site audit of the Clinical Trial Center shall be arranged by the Head, of clinical research in coordination with the Head, of QA & Market Research or Head, QA, or by a consultant.
• Upon successful completion of the clinical trial, the data shall be compiled & submitted to DCGI by RA or Clinical Research. After approval by DCGI, RA shall apply for a manufacturing license.
• After obtaining the manufacturing license the head – RA arranges for the distribution of copies of mfg. license to the concerned department. 
• After DCGI permission, the respective marketing division shall submit samples and sales estimates (strength-wise, annual, and first 4 months). Refer ‘Brand Plan Module. A new product price proposal shall also be circulated by the respective marketing division to all members of NPDC & Logistics.

Phase VI: Product Development Process

• From laboratory scale successful trials & data generation up to manufacturing of product at production floor four months are required.
• Head, R&D shall arrange for the schematic presentation of the manufacturing process & testing procedures of the new product to the concerned departments. Accordingly concerned department shall give inputs regarding improvement in the manufacturing process/testing procedures to the Head, R&D. If possible such suggestion can also be incorporated in the final Master Formula or Spec/STP. Head, R&D shall also arrange for the issuance of tentative Master Formula (Manufacturing / Packaging) to the concerned department.
• Head QA and Head RA shall arrange for the final compilation of data on label claim, composition, brief manufacturing procedure, raw/packaging material specification, stability data, and primary packaging development.
• After obtaining the Mfg. license the Head, RA shall arrange for the distribution of copies of Mfg. license to the concerned department.
• Final Master Formula (Mfg & Packaging), Spec. / STP of Raw and Packaging material, Finished Product, and In-process Material shall be generated by R&D.
• After approval of Master Formula, Spec. / STP of Raw / Packaging Material, Finished Product, In-process, QA shall distribute the required document to the concerned department(s).
• After receiving the Raw/Packaging material specification by QA, Materials Management shall proceed with the procurement of the raw/packaging material from the approved vendor.
• Raw / Packaging material approved by QC shall be used for manufacturing the new product.
• The process for designing artwork shall be initiated in parallel. R&D shall generate the facsimile label and forward it to the Head, of Clinical Research, RA, and QA for approval.
• After approval, a label shall be forwarded to Materials Management or Packaging Designing, and accordingly, artwork shall be initiated. This artwork shall be approved as per the SOP ‘Designing and Approval of Artwork’.
• R&D shall send samples of the new product manufactured at lab scale to the Head, of Production with specifications for the required dies & punches, any additional change part &/or any additional instrument/machine (if required).
• Head, Production shall arrange for the required dies and punches, and if required machine change parts or any additional machine/equipment.
• Qualification studies for any new equipment/machine to be used for a particular new product shall be completed before initiation of manufacturing of that product as per the company’s Master Validation Plan.
• After ensuring the availability of approved raw / packaging material, dies and punches, change parts & facility, Head, Production shall give BMR Issue Request to the quality assurance (refer SOP ‘Issue, receipt, storage and destruction of Batch ManufacturingRecords)
• Head, QA shall ensure availability of Mfg. Lic., approved Specs / STPs of all Raw /Packaging material, In-process Material, Finished Product, Technical Direction (Mfg.&Packaging), validation protocol (if required) and then issue the BMRs to the Productionensuring the availability of approved raw and packaging materials in the stores.
• The first three commercial batches shall be manufactured under the supervision of an R&D scientist. Any change done during the optimization shall be documented on from change(s) Done During Optimization’. This form shall be enclosed with the respective BMR after specifying changes along with reasons. A process validation shall be carried out for the three consecutive batches as per the specific requirement of any country or regulatory authority.
• Production Scale-up Batch Report (SUR) shall be generated by Production in coordination with R&D regarding the summary of optimization changes done on the production floor.
• Each Scale-up Batch Report shall be numbered by production having nine characters as 

SURXXX/YY 

where

SUR: Stands for Scale-up Batch Report

XXX: Denotes serial numbers starting from 001 to 999.

YY: Respective year

• A SUR shall be reviewed by R&D, and QA & any change in process shall be handled as per the SOP titled ‘Change Control’.
• A New Product Launch Activity Chart shall finally be closed by QA after the successful manufacturing of the new product on the production floor.

Abbreviations

ARD: Analytical Research and Development

COA: Certificate of Analysis

DCGI: Drug Controller General of India

FRD: Formulation Research and Development

GCP: Good Clinical Practices

GMP: Good Manufacturing Practices

MSDS: Material Safety Data Sheet

NPDC: New Product Development Committee

NPDP: New Product Development Process

NPLAC: New Product Launch Activity Chart

PDR: Product Development Report

PSR: Product Specification Report

STP: Standard Test Procedure

SUP: Scale-up Batch Report

SOP: Standard Operating Procedure

FRD: Formulation Research Development

QAD:  Quality Assurance Department

QCD: Quality Control Department

ARD: Analytical Research Development

Revision History

Nil

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