Developing a Standard Operating Procedure for Product Development is crucial for ensuring consistency, quality, and efficiency in the development process. Here’s a general outline for creating an SOP for product development. Please tailor this outline to fit the specific needs and processes of your organization and industry:
PURPOSE
To define and document a procedure for pharmaceutical product development.
SCOPE
This procedure applies to development of new pharmaceutical product.
RESPONSIBILITIES
- The Managing Director (MD / CEO) approves the initiation of the project.
- New Product Technical Committee (NPTC) is responsible for designing and documenting inputs and outputs of design and development activities. This committee comprises of:
- Executive Director (Technical)
- General Manager (Quality Operations)
- Chief Manager (Procurement)
- Senior Manager (Quality Control)
- Senior Manager (Method Development & Validation)
- Senior Manager (Production)
- Senior Manager (Regulatory Affairs)
- Manager (Product Development)
- Manager (IPC & Documentation)
- Executive Director Technical [EDT] plans the design and development activities.
- Manager Product Development defines and documents design Inputs & design reviews and executes the Design & Development plans while implementing and monitoring the activities continuously and updating the plan.
- In-charge Quality Control [SMQC] prepares and documents specifications of finished products, raw and packaging materials.
- In charge Method Development and Validation [SM(MD, V)] develops and validates analytical / testing procedures and any other test required for ensuring quality of the product.
- Senior Manager (Production) arranges for machines and required facilities, personnel & area(s).
- Product Development Team (PD Team) defines design inputs, conducts trials, process validation and reviews.
- Chief Manager (Procurement) arranges for the raw and packaging materials, equipment’s and other resources.
- Senior Manager (Regulatory Affairs) prepares Registration Dossier for the registration of the product and follows up with the Ministry of Health.
- Respective Product Manager initiates designing of packaging / promotional materials, inserts, literature etc. in consultation with Chief Manager Procurement Head.
PROCEDURE
- New Product ideas / requirements
- The new product ideas / requirements are forwarded to:
- Managing Director / Chief Executive Officer (MD/CEO)
- New Product Technical Committee (NPTC)
New product ideas are derived from either one or more of the following groups:
- Suggestions to New Product Technical committee
- Brain storming sessions arranged by MD.
- Market survey and literature
- Competitor’s product samples
- Customer requirements – In case of Export
- In-house designing efforts (from original research Products)
These ideas and requirements are reviewed by the ED (Medical) and ED (Marketing), recorded on Project Initiation Form approved by the MD / CEO and is forwarded to EDT for further working.
Project Planning & Design Inputs / Product Development
Design & Development Planning: Executive Director Technical [EDT] prepares Design and Development Plan for the project indicating the design phases, departmental interfaces during the design process, tentative planned duration of each design phase, etc. The tentative durations are only minimum projected durations and may vary depending on the availability of resources and personnel. The plan is forwarded to Manager Product Development along with the Project Initiation Form for execution.
Literature Survey
- Literature Survey is conducted using different sources of information like United States Pharmacopoeia (USP), British Pharmacopoeia (BP), British Pharmaceutical Codex (BPC), Pharmaceutical Codex (PC), European Pharmacopoeia (Eur. Ph.), Martindale Extra Pharmacopoeia, Martindale The Complete Drug Reference, Merck Index, Physician Desk Reference (PDR), Chemical Abstracts (CA), Internet, Reference Books, or any other relevant source that is suitable for the purpose. Pharmacist(s) PD carries out the literature survey and submits a Literature Survey Report to Head of Product Development for review. Copies of all collected references are attached with the form.
- MPD submits the report to EDT with his comments (if any) after reviewing it.
- EDT returns the report to the MPD with his suggestions / recommendations (if any).
Innovator’s / Competitor’s Product Analysis
- MPD selects one or more than one brands of the product available in the market; one should preferably be the innovator’s product, and requests Regulatory Affairs (RA) Department for the purchase of these products. SM (RA) ensures the purchase of these products.
- MPD requests the QA for analysis (if required) on the prescribed QA Analysis Request Form and In-charge Quality Control reports the results after completing these tests. Pharmacist PD (PPD) assists in checking / performing the Physical checks / tests.
- After receiving the results, PPD prepares a Competitor(s) Product Survey Report and sends it to MPD for checking and review.
- EDT & MPD check and review the report and start working on the tentative formulation.
Design Inputs and formulation Plan
- Product Development Team (PD Team) under the supervision of MPD starts working on the tentative formulation of the intended product, prepares a tentative formulation and records the formulation and other design inputs on the Design Input Form and forwards it to EDT for review.
- EDT approves the plan after discussing the report in NPTC meeting.
- After the approval of design inputs from NPTC, SM [MD, V] starts the development / preparation of the analytical procedures and documentation of raw and finished product specifications.
- After the completion of the tentative formulation, MPD sends the Formulation to SM (RA) for Preparation of the Registration File.
- SM (RA) prepares the Registration Dossier and follows-up with the Ministry of Health.
Project / Product Realization.
- After the registration of product, MPD requests for opening of the codes of materials required for the product and entrance of the tentative formulation into the software to start the material requirement planning for trial and commercial batches. This request is raised on Raw Material & Packaging Material code Opening/ Amendment Form.
- CM (Procurement) / ED (BD) sources out and arranges either local or imported materials.
- MPD prepares the protocol on Manufacturing Protocol Form for the trial batch considering all the details to be inferred from the trial and sends it to EDT for review and approval.
- EDT reviews and approves the protocols.
- After the arrangement of the Raw materials, MPD plans and directs the assignment to PD Team to conduct the trials and recommends the analysis of samples of trials to QC for verification against the design inputs on the prescribed form.
- QC checks the submitted samples against the defined specifications and forwards the Analysis report to the Product Development Department.
- PPD Documents the trial batch records and analysis report and the results of the trial are discussed and reviewed by the Product Development Team.
- If the submitted samples of the trial batch to the QC fail to meet the set parameters / standards, the Product Development team, keeping in view the results of the first trial batch, plans a second trial batch. The activity of trial batch may continue till the desired outputs are achieved. This activity is completed within 6 weeks of the receiving raw material.
- After the completion of the trials, PD Team prepares the trial report and sends it for review to EDT.
- If the trial results comply with the design inputs then the EDT approves the preparation of commercial batch.
- Samples from the first three commercial batches are subjected to Accelerated and Real Time Stability Studies according to SOP GM (QO) reviews the report and approves the initiation of the stability study.
Stability Studies
- General Manager Quality Operations upon conformation of CA (Certificate of Analysis) with the Design Input parameters directs the MPD to submit samples from the first three commercial batches to SM [MD, V] for Stability Studies on prescribed Stability Study Request Form.
- SM [MD, V] prepares a stability protocol for the product according to SOP and keeps the PD posted on any developments.
- The Final report of the study is compiled after completion of the stability study period. The interim reports of the study may be issued based on the six months, one year and two years results for record purposes.
- For any deviations / failures during the stability studies, SM [MD, V] apprises the MPD who reviews the results and intimates the findings to the EDT.
- EDT holds a Design Review Meeting with Product Development Team, General Manager Quality Operations and In-charge [MD, V] where probable causes of deviation / failures are discussed and modification in the product formulation are proposed and approved.
- The decisions / modifications in the intended product formulation are implemented through Process revision Form.
Departmental Interfaces
The following departments are involved during the design and development phases:
Department Resource Person, Function/Activity
- Product Development M (PD) Literature survey, collection of information regarding product, definition of design inputs, preparation of the trial batches & samples, defining specifications of Raw materials and products, documentation and preparation of production protocols, BMRs, process validation protocols & reports.
- Quality Control SM (QC) To prepare and document Specifications of finished products, raw and packaging materials
- Quality Assurance SM (MD, V) To develop / validate Quality Assurance testing procedures, to carry out stability study or any other special test required to ensure quality of the product.
- Production SM (P) Arrangement of the machinery, area, facilities and personnel for production of trial & commercial batches.
- Planning & Procurement CM (Procurement) Sourcing and arrangement of raw & packaging materials, equipment and other resources.
- Business Development ED (BD) Arrangement of the materials not locally available. Liaison with foreign principals / Suppliers and customers.
- Regulatory SM (RA) Preparation and submission of Registration File and follow-up with MOH. Communication of Regulatory requirement regarding the Product & Procedure to concerned department.
- Accounts Mgr. (Accts.) Costing and feasibility study.
- Marketing SM (Training) Market Survey, Designing of Packaging / Promotional materials, inserts, literature etc. Preparation of Launch plan and final launching.
- Medical Medical Advisor Review and checking of Inserts & Packaging Materials from Medical/ clinical point-of-view. Arrangement of clinical, bio-equivalence studies & preparation of reports, study of the clinical and medical aspects of the product.
Design & Development Output
The MPD is responsible for documenting and maintaining the design outputs.
The design outputs may be in the following form:
- Master Formula
- Standard Batch Manufacturing Record (BMR)
- Specifications of the Finished product and raw materials required
- Quality Assurance and testing procedures
- Packaging and promotional Materials
The master formula and manufacturing methods are recorded and documented in the Batch Manufacturing Record (BMR) by MPD, reviewed by GM (QO), checked by EDT and finally approved by the MD / CEO.
Design & Development Reviews
At defined stages, design reviews are carried out to discuss the design features and design problems (if any).
The design reviews are carried out at the following stages:
- 1st review is by New Product Technical Committee after finalization of design inputs.
- 2nd review by CM (QA) after the completion of trial batch.
- 3rd review by the concerned members of NPTC after the completion of Stability study.
Design & Development Verification
At defined stages, design verifications are carried out to ensure that the design output for a specific phase meets the design input of that phase.
The verification activities include:
- In-process Checks
- Final testing of the finished product
- Stability Study
- Bio availability / Bio-equivalence Study (If Required by MOH)
The design verification results include the following reports:
- BMR including IPC Data Sheets
- Certificate of Analysis
- Stability Study Report
Design & Development Validation
After completion of the trial of final design, design validation is carried out to ensure that the final designed product meets the intended use or application.
Design validation activities include:
- Process Validation MPD Process Validation activities are carried out on first three commercial batches. MPD Prepares the Process Validation Protocols (according to SOP and BMR, Pharmacist(s) PD assist in this activity. PD Team supervises the preparation of first three commercial batches assisted by the production to complete the validation process. Pharmacist(s) PD Prepare the Validation report and circulate it to all validation team members for checking and to General Manager Quality Operations and Senior Manager Production for their comments and recommendations. The samples from first three commercial batches are subjected to accelerated and real time stability studies.
- Analytical Procedure Validation SM (MD, V) Analytical procedure validation is carried out according to SOP.
- Stability Study SM (MD, V) Samples from the first three commercial batches are subjected to accelerated and Real Time Stability Studies according to SOP.
The design validation results include the following reports:
- Finished Product specification
- Process Validation Report and BMR
- Analytical Procedure validation Report
- Stability Study
After satisfactory validation results of final designed product, the Active Material Specification, Finished Product Specification, method of analysis and BMR are finalized and approved by the concerned authorized signatories. A copy of the finalized and approved master formula containing names and quantities of active and excipients, detailed method of testing of finalized drug are sent to Head of RA for onward information to MOH.
Design Changes
Request for design changes is made through Process Revision Form
These can be raised by the following functions on the basis of reasons mentioned against them:
DEPARTMENT BASIS FOR CHANGE
Quality Assurance / Quality Control Stability and analytical results basis
Production Non-availability of Facility and manufacturing problems
Regulatory Department Some regulatory issues or change of regulatory requirements
Marketing Marketing Need and Demands
Business Development Customer/Export Market requirements
All requests for changes are reviewed by the Product Development, QO and Production heads for the following, as appropriate:
- Changes in design input
- Changes in materials Specs (Actives, excipients and packaging)
- Quality aspects/specification of the final / Finished product
All changes are approved by the MD or his appointed nominee / EDT. Where required, design changes are reviewed with customers, when specified in the contract and all such changes are also approved by the M D or his appointed nominee.
ASSOCIATED DOCUMENTS
- Process Validation Report & BMR
- Quality Assurance Data including Raw Material, Packaging material and Product Specifications, Analytical Method Validation Report and Stability Study Reports.
- Tooling Design, packaging and promotional materials Designs
- Legal/Regulatory documents including Registration Dossier and registration Certificate
RELATED RECORDS
- Product Initiation Form
- Product Design Plan
- Design input
- Trial Batch Records
- Process Validation Report
- Analytical Procedure Validation Report
- Stability Study Report
- Raw Material Specifications
- Packaging Material Specifications
RELATED SOPS AND FORMS
a. Forms
- Project Initiation Form
- Design and Development Plan
- Design Input Form
- Design Review Form
- Process Revision Form
- Literature Survey Report
- QA Analysis Request Form
- Competitor(s) Brand Survey Report
- Stability Study Request Form
- Raw Material & Packaging Material code Opening/ Amendment Form
- Manufacturing Protocol
- New Product Packaging Development Form
b. Standard Operating Procedures (SOPs)
- SOP for stability Study
- SOP for Analytical Procedure Validation
- SOP for Process Validation
- SOP for Homogenizer Ultra-Turrax
c. Standard Cleaning Procedures (SCPs)
- SCP for Homogenizer Ultra-Turrax