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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.

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 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.
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 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”.
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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

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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

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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:

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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

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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

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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

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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

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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

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Remarks:

Any Other Comments:

Comments:

Comments: (Approved/Rejected):

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