Product Development Process (PDP) pharmaceutical, 5 Phases to Consider

Rahul Kashyap


Product Development Process (PDP)pharmaceutical , 5 Phases to Consider


This SOP describes the standard procedure for product Development process


Product development process shall be handled in phases. All phases shall be executed simultaneously or sequentially as per requirement during new product development process.

Phase I: product Development process

Designee-FRD (Refer Abbreviation in the end of article), 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 development process and plan the strategy to launch the product.

product development process flow
 Phase II:

·         Head of business development and Asst. Manager/ Manager – FRD initiate the product initiation form in coordination with respective department head and fulfil all the details mention in product initiation form.

·      Depending on the product requirement Designee – FRD shall do some Literature search and market sample (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 company.

Phase III: product Development process

·         Head FRD shall go through all the details of the identified product mention 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 specifications of raw and packaging materials respectively required for the product. At the same time 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 forwarded it to material management.

·         Material management consecutively shall initiate vendor approval.

·         Head FRD shall finalize composition, label claim, tentative manufacturing procedure, finished product specification after the availability of the required raw and packaging materials and machine parts initiate preparation of laboratory pilot scale batches of new product.

·         At the same time head -ADL shall start the development of the STP for in-process /finish product and stability data indicating method. The analytical method development data shall submit to head -FRD and head- QA for review.

·         Head – FRD shall arrange for the stability testing for the product developed at laboratory pilot scale. A stability data shall be generated after accelerated study of at least three months by analysing stability samples and maintain record in stability register

·         In case any pilot batch is failed in manufacturing process/testing therefore destruct the product as per system and maintain record in destruction record register

After successful completion of laboratory pilot scale batches of identified/selected product at laboratory scale, head- FRD shall provide following required data to head – RA for of the manufacturing license.



             Brief manufacturing process

             Raw material and finished product specifications/STPs

             Certificate of analysis

             Stability data – minimum three months accelerated stability studies.

Phase IV: product Development process

·         RA department shall apply for DCGI permission for the manufacturing after receiving data from FRD.

·     Simultaneously QA in conjugation with material management shall start the process to approve the vendors for the raw material as well as packaging.

Phase V:

·      After obtaining the manufacturing license the head –RA arrange for the distribution of copies of mfg. license to the concern department.

·        Final Master Formula Record (MFR) shall be generated by FRD.

·       After approval of MFR, spec. and STPs of raw/packaging material, in-process and finished product, QA shall distribute the required document to the concern departments.

·      After receiving all the required documents material management shall proceed for the procurement of the raw/packaging materials from the approved vendors.

·         Only approved raw/packaging by QC shall be used for manufacturing of product.

·      Head – QA shall initiate the technology transfer process for the product manufacturing in production floor.

·      After ensuring the availability of approved raw/packaging material, machines and facilities head – production shall give BMR issue request to the QA.

·    Head – QA shall ensure the availability of mfg. license and approved MFR, spec. and STPs of raw/packaging material, in-process and finished product, validation protocol and then issue the BMR to the production.

·     The first three commercial batches (Process validation batches) shall be manufactured under supervision of FRD Designee. Any change done during optimization shall be documented on.


Abbreviation     Extended Form

SOP        Standard Operating Procedure

FRD        Formulation Research Development

QAD       Quality Assurance Department

QCD       Quality Control Department

ARD       Analytical Research Development

NPDP    New Product Development Process

DCG       Drug Controller General

COA       Certificate of Analysis

STP         Standard Test Procedure

MFR       Master Formula Record

RA          Regulatory Affair

HOD       Head of Department


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