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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.

Guideline for  Introduction of Product

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  :
  • Prepare and send the Formulation Development Report, Master Formula Record, Specifications and Standard Test Procedures to the Quality Assurance.
  • Coordinate with Production and Engineering for new requirements in terms of facility / equipment.
  • 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 :
  • Execute process validation protocol and compile the report.
  • Introduced and maintained all new products at manufacturing site.
Quality Control :
  • Provide necessary support for the testing of product.
  • To identify & qualify the outside testing laboratories.
Engineering :
  • Provide necessary support for the maintenance of GMP area and plant machineries /equipment.

4.0   Procedure – New Product Introduction:

    • 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 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, pharmacopoeial 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 – New Product Introduction :

    • Impact assessment shall evaluate for additional equipment qualification requirements, additional cleaning validation requirements and impact on the existing master document like SMF, VMP, etc.
    • For identifying GMP affected system /document, Annexure-I shall referred for the facilitation of impact assessment.
    • If manufacturing technology requires creation/up-gradation of existing manufacturing facility, the same shall be done.
    • Based on the requirement of the product, PDL shall propose for the new machines required.
    • Head Production shall evaluate the same and arrange for the procurement of machine change parts/ tooling.
    • After receipt of the machine, the same shall be installed and qualified as per approved procedure.
    • The recommendation & assessment of production shall be checked & assessed by QA and forwarded to QC.
    • 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.
    • If a specific test cannot be performed in-house, Quality Control shall evaluate the possibility of analyzing the same in a Contract Testing Laboratory.
    • 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 :

    • Quality Assurance shall assess the feasibility & assessment of the Production, PDL, QC & purchase for the final assessment.
    • 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.
    • Analytical Department shall provide the necessary analytical testing procedures for the same.
    • 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.
    • After the satisfactory review & comment by the Head-QA, the change control shall be initiated for the introduction of new product.
    • 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”.

5.0   Reference – New Product Introduction :

  • ICH Q10

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

7.0   Annexure – New Product Introduction :

Annexure I : Check list 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:
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
Name of Starting material Pharmacopoeial reference Reference Docket Number (STP/SPEC.) Vendor Approved

(Y/N)
Compiled by:

To be Filled by Production

Feasibility of the manufacturing and packing of the product at the site:
Provision of any new equipment required:
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:
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:
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:
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:
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
Remarks:
Any Other Comments:
Comments:
Comments: (Approved / Rejected):

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Janki Singh

Mrs. Janki Singh is the professional pharmaceuticals Blogger. She has already posted more than #1000 articles on varrious topics at different blogging plateforms. Contact : guideline.sop@gmail.com