SOP on New Product Design and Development Process
The objective of the New Product Design and Development Process :
To lay down a Procedure for New Product Design and Development Process.
Scope :
This Standard Operating Procedure is applicable all pharmaceutical formulation plants of Pharmaceutical Companies.
Responsibility
Head, Clinical Research:
Conducting 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 of manufacturing License and applying for manufacturing License.
Head, Materials Management:
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 products and if required assistance in purchasing new machines, and 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 with the procedure and continuous sending of the updated current status of the Product under development to QA.
Abbreviations and Definitions
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, A group generally comprising Heads of all operational departments i.e. QA, QC, Production, Materials Management, Marketing, QA (M) & Market Research, R&D, Clinical Research, RA, and committee being headed by Joint Managing Director.
NPDP: New Product Development Process
NPLAC: New Product Launch Activity Chart
PDR: Product Development Report
Phase: Distinct period or stage in the process of development of the product.
PSR: Product Specification Report
STP : Standard Test Procedure
SUP : Scale-up Batch Report
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
The NPDC shall discuss conceptually the new product(s) development status at the R&D in the NPDP meetings. 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.
Phase II
Depending on the product’s requirement in the market, Head-QA & Market Research shall initiate a ‘New Product Development Request’ in coordination with the respective Marketing head and shall fill in all the details mentioned in the ‘New Product Development Request’.
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 serial number of the request starting from 001 to 999.
- YY: Denotes the 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 2023 shall be numbered as NPD005/23.
Head, QA (M) & Market Research shall forward the filled ‘New Product Development Request’ to the Head-R&D.
If required Head, QA- Market Research shall provide innovator/reference products available in the market to the R&D.
Phase III
Head, FRD shall go through all the details of the identified product mentioned in the New Product Development Request and shall proceed with the development of the new product at the laboratory scale.
FRD and Packaging Development personnel shall develop specifications of the Raw and Packaging Materials respectively required for the new product development. At the same time, the Analytical Research and Development Department shall develop STP for the specified raw material/packaging material.
Head, FRD shall raise the requisition for the raw/packaging material along with the tentative specifications and machine change parts / new machine for the product development & forward it to the Head-Materials Management.
Materials Management shall procure the raw/packaging material and machine change parts if required as per the specifications provided by the FRD. The Head, of Materials Management, shall also arrange for raw / packaging material with the manufacturer’s COA and MSDS and reference Standards.
Materials Management consecutively shall initiate the vendor approval process.
Head, FRD shall finalize composition, label claim, tentative manufacturing procedure, and Finished Product specification after the availability of the required raw and packaging material and machine change parts and initiate preparation of Laboratory Pilot Scale Batches of a new product. Upon successful completion of Laboratory Scale batches of new products, a Product Development Report shall be generated by Head-FRD (refer to Annexure-II) along with 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 number 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 product and data on stability indicating method. The analytical method development data shall be submitted by the Head, ARD to Head-QA for review.
Head, FRD shall arrange for the stability testing of the new product developed at laboratory pilot scale. Stability data shall be generated after an accelerated study of at least three months by analyzing stability samples.
The PDR, PSR, and accelerated stability study data shall be provided by R&D to QA for review.
QA shall prepare 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 products at laboratory scale, Head-FRD shall provide the following required data to Head-RA for application of the manufacturing license.
- Label
- Composition
- Brief Manufacturing process
- Raw material and Finished Product specifications/STPs
- Certificate of Analysis
- Stability data – minimum 3-month accelerated stability studies, Dissolution Profile, etc.
Phase IV
NPDC shall decide whether the new product shall be manufactured In-House or at Contract Manufacturing (Loan License / Third Party)
RA department shall apply for DCGI permission or the manufacturing License after receiving the required data from the R&D.
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 (If applicable)
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.
The Head, of Clinical Research shall arrange for clinical trials as per the Good Clinical Practices or available SOPs 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.
Head, RA shall inform the respective marketing division regarding DCGI approval.
After DCGI permission, the respective marketing division shall submit sample and sales estimates (strength-wise, annual, and first 4 months). Refer to ‘Brand Plan ModuleTM’ . New product price proposals shall also be circulated by the respective marketing divisions to all members of NPDC & Logistics.
Phase VI
From laboratory scale successful trials & data generation up to manufacturing of product at production floor four months are required.
The head, of R&D, shall arrange for a schematic presentation of the manufacturing process & testing procedures of the new product to the concerned departments. Accordingly, the concerned department shall give inputs regarding improvement in manufacturing process/testing procedures to the Head, of R&D. If possible such suggestions can also be incorporated in the final Master Formula or Spec/STP. The Head, of 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 Products, 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 parallelly.
R&D shall generate the facsimile label and forward it to the Head, Clinical Research, RA, and QA for approval.
After approval, a label shall be forwarded to Materials Management or Packaging Designing (as the case may be) 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, 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 the 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, the Head, of Production shall give BMR Issue Request to the Quality Assurance (refer to SOP ‘Issue, receipt, storage and destruction of Batch Manufacturing Records)
Head, QA shall ensure availability of Mfg. Lic., approved Specs / STPs of all Raw / Packaging material, In-process Material, Finished Products, Technical Direction (Mfg.& Packaging), validation protocol (if required), and then issue the BMRs to the Production ensuring 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 the form ‘Change(s) Done During Optimization’ (Annexure-VI). This form shall be enclosed with 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 at 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 number 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.
Forms and Annexure
- New Product Development Request – Annexure-I
- Product Development Report – Annexure-II
- Product Specification Report – Annexure-III
- New Product Launch Activity Chart – Annexure-IV
- Brand Plan Module – Annexure-V
- Change(s) Done During Optimization – Annexure-VI
- Scale-up Batch Report – Annexure-VI
Distribution:
- Master copy – Documentation Cell (Quality Assurance).
- Controlled copies – Documentation Cell, QA & Market Research, Production, Quality Control, Regulatory Affairs, Materials Management, Clinical Research.
History
