(https://guideline-sop.
com/new-product-introduction/)
New Product Introduction Procedure and QRM
Standard Operating Procedure and Guideline for New Product Introduction in existing set of
product list and equipment trail and Quality Risk Management at Pharmaceuticals Drug
Manufacturing Plant.
SOP for New Product Introduction
1.0 Objective
To lay down the procedure for introduction of new product at the manufacturing
location.
2.0 Scope
This guideline is applicable for Introduction of new product & Introduction of existing
product with new brand name at pharmaceuticals drug manufacturing plant.
3.0 Responsibility
Production Development Laboratory:
1. Prepare and send the Formulation Development Report, Master Formula Record,
Specifications and Standard Test Procedures to the Quality Assurance.
2. Coordinate with Production and Engineering for new requirements in terms of
facility/equipment.
3. Coordinate with Quality Assurance for development of artwork.
Production:
To check Production feasibility and equipment suitability to provide the facility for
intended manufacturing process and batch size.
Quality Assurance:
1. Execute process validation protocol and compile the report.
2. Introduce and maintain all new products at manufacturing site.
1
Quality Control:
1. Provide necessary support for the testing of product.
2. To identify & qualify the outside testing laboratories.
Engineering:
Provide necessary support for the maintenance of GMP area and plant
machineries/equipment.
4.0 Procedure
Introduction of a new product at a location is decided by Marketing Department in
coordination with PDL and Drug Regulatory Affairs.
After receipt of details for introduction of new product/existing product with new brand
name, QA shall initiate the Annexure-I “Checklist for introduction of new product (NPI)”.
QA shall fill in the technical details in the Annexure-I and complete preliminary
assessment.
If required collect the technical information from PDL.
QA shall fill the product name, brand name, label claim, shelf life, storage condition of
product, therapeutic category, customer/market, certification for relevant market,
contact giver, technical agreement availability, API details, pack style, packing material
details.
A list of starting materials, pharmacopeial reference and Specification and STP No., and
their qualification shall be defined or a signed document shall be enclosed stating
above.
After filled by QA the checklist shall be forwarded to Production for assessment of the
feasibility of manufacturing of said product in existing facility.
Additional facility requirement shall also be documented accordingly if required.
Production shall also check the suitability of storage, facility, equipment and
requirement of new equipment, etc.
Impact Assessment:
1. Impact assessment shall evaluate additional equipment qualification requirements,
additional cleaning validation requirements and impact on the existing master
document like SMF, VMP, etc.
2. For identifying GMP affected system/document, Annexure-I shall referred for the
facilitation of impact assessment.
2
3. If manufacturing technology requires creation/up-gradation of existing
manufacturing facility, the same shall be done.
4. Based on the requirement of the product, PDL shall propose the new machines
required.
5. Head Production shall evaluate the same and arrange for the procurement of
machine change parts/tooling.
6. After receipt of the machine, the same shall be installed and qualified as per
approved procedure.
7. The recommendation & assessment of production shall be checked & assessed by
QA and forwarded to QC.
8. The checklist shall be forwarded to QC for assessment of the feasibility of testing
and shall arrange the chemicals, working standards, HPLC columns, etc., required for
the analysis as per the test procedures.
9. If a specific test cannot be performed in-house, Quality Control shall evaluate the
possibility of analyzing the same in a Contract Testing Laboratory.
10.The checklist shall be forwarded to Purchase Department for the availability of
starting materials & identification of the vendor for procurements of the starting
material.
QA Assessment:
1. Quality Assurance shall assess the feasibility & assessment of the Production, PDL,
QC & purchase for the final assessment.
2. QA shall update the cleaning validation matrix based on the machines to be used for
manufacturing and perform the cleaning validation as per the requirement.
3. Analytical Department shall provide the necessary analytical testing procedures for
the same.
4. After the final assessment by QA the checklist shall be forwarded to Head Production
& Head QA to ensure that the manufacturing activity shall be carried out at the
manufacturing site after execution of Annexure-I by relevant Department. The final
satisfactory comment shall be incorporated by Head Production & Head QA with
signature and date in Annexure-I with respect to new product introduction.
5. After the satisfactory review & comment by the Head-QA, the Change Control shall
be initiated for the introduction of new product.
6. Products to be manufactured on Contract basis for other companies or own for
which technology is to be received from other manufacturers shall be handled as per
SOP for “Technology Transfer”.
3
5.0 References
1. ICH Q10
2. SOP…
6.0 Glossary
SOP Standard Operating Procedure
QA Quality Assurance
QC Quality Control
PDL Product Development Laboratory
VMP Validation Master File
SMF Site Master File
FDA Food & Drug Administration
HPLC High Performance Liquid Chromatography
TSE Transmissible Spongiform Encephalopathy
BSE Bovine Spongiform Encephalopathy
4
7.0 Annexure
Annexure-I: Checklist for New Product Introduction (NPI)
To be filled by QA Department
Brand name of product
Generic name of product
Label claim
Strength
Shelf-life
Storage condition
Dosage form
Product permission from FDA
Therapeutic category
Customer/Market
Certification for relevant market
5
Contract giver details
Technical agreement availability
API details
Pack style
Packaging material details
Basis for assessment
(Details of document received)
Details of starting raw material to be used in manufacturing and packing
Reference Docket
Name of Starting Pharmacopeial Vendor Approved
Number
material reference (Y/N)
(STP/SPEC.)
Compiled by:
To be filled by Production Department
Feasibility of the manufacturing and packing of
the product at the site
Provision of any new equipment required:
6
Storage condition of product/raw materials
Provision for any up-gradation of existing
equipment required
Feasibility with respect to the batch size and
pack size of the product
Any other requirement to handle the product
Feasibility of development of artwork
Development of packing materials
Any New change part required:
Remarks:
To be filled by QA Department
Name of Raw materials, which are to be
qualified before procurement
Feasibility for the storage condition of
starting materials
7
Provision for new storage condition
required, if any
Feasibility with respect to the handling of
starting materials
Feasibility with respect to the dispensing of
starting material
Remarks:
Assessment Done By :
Assessment by QC
Feasibility with respect to the
technology transfer of analytical
methods shall arrange to Quality
Control
Starting materials feasibility with
respect to the handling/sampling
Feasibility with respect to the analysis
of starting materials
Any new instrument/attachment/up-
gradation is required for analysis
8
Feasibility with respect to the quantity
and storage of samples
Remarks:
Assessment by Purchase Department
Feasibility for the raw material procurement
from approved vendor at the site
Feasibility for the packing material
procurement from approved vendor at the site
9
Provision for any up-gradation/Qualification of
existing vendor if required
Feasibility with respect for the raw material
arrangement with respect to NPI at the site
Feasibility with respect for the packing
material arrangement with respect to NPI at
the site
Provision of any changes if required by Market
Authorization/regulatory affairs
Remarks:
Assessment by Quality Assurance Department
Feasibility for the manufacturing
and packing of the product at the
site
10
The specified suggested vendor
already is in vendor list or has to
be qualified before procurement,
if yes then the name of material
and vendor
Feasibility with respect to the
storage condition and quantity of
control sample
Feasibility with respect to other
products
Qualification/validation status of
equipment /process Feasibility
with respect to NPI
Feasibility with respect to stability
study of finished product
Feasibility with respect to the
sampling/handling of in-process
and validation samples
Updating of cleaning validation
matrix
Is product of shows the
characteristic of Genotoxicity/
TSE/BSE contamination
11
Remarks:
Any Other Comments:
Comments:
Comments: (Approved/Rejected):
12
