SOP on Technology Transfer of Drug Product

Technology transfer/product transfer is a complete documented process that covers the detailed documentation for manufacturing and dispatch of the first batch, received from the parent location or FDD of a new or existing product from a particular site with manufacturing, packaging and analytical details.

SOP on Technology Transfer of Drug Product

1.0      PURPOSE:

  • The purpose of this SOP is to define the procedure to be followed for a successful transfer of new technology or product (Technology Transfer of Drug Product) from-
    • One manufacturing site to another site of same manufacturing group / company or
    • Formulation Development Department (FDD) / R&D to manufacturing site.

2.0      SCOPE :

  • Scope of this SOP covers
    • All existing products being transferred from one site to another site and
    • New products from FDD .

3.0      REFERENCES:

  • SOP for Risk Management
  • SOP for Stability Program
  • Analytical Method Transfer procedure
  • WHO Guidance on Tech Transfer
  • Change Control Procedure

4.0      RESPONSIBILITY:

  •  Formulation Development (FDD):-
    • Responsible to provide Technology transfer documents (MPS/PIF) to location.
    • Organize meeting with location after circulation of above documents,
    • if required, Present at location while manufacturing of initial batches.
    • Specification,
    • Analytical Test Procedure,
    • Analytical Method Validation and
    • Organize meeting with location after circulation of above documents, and
    • if required, Guide /support and demonstrate about the skill involved in analysis as per requirement.
    • Approved art works,
    • Packaging material descriptions
    • Pack profile to location
    • Participate new product launch meeting and process development/scale up trials if required.
  • Production Officer / Executive:-
    • Responsible for review of-
    • Product Information File (PIF) / Master Product Specification (MPS) on receipt,
    • Plan for batch,
    • Raise Purchase Request (PR) for additional facility required,
    • Up-load the Bill of Material (BOM) in Metis or other adopted software and
    • Prepare of Batch Manufacturing Records (BMR) / Batch Packing Record (BPR), Risk Assessment Report (FMEA).
  • Warehouse Dept.:-
    • Responsible to Raise Purchase Request for Raw materials / Packing materials, check availability of materials.
    • Ensure that materials are receipt & stored as per SOP of receipt.
    • Storage of materials.
    • Dispensing of material as per the batch manufacturing plan.
    • Review of the PIF/MPS on receipt, authorize, issue the BMR / BPR, plan validation activity as per validation plan,
    • Review Risk Assessment Report / FMEA report and evaluate mitigation plan prior to the manufacturing of batches.
    • Preparation of Standard Testing Procedure (STP), Analytical Test Data Sheet and
    • Qualification of working standards in accordance with the product requirements.

5.0      DEFINITION:

  •  Technology Transfer:
    • Technology transfer/product transfer is a complete documented process which covers the detailed documentation for manufacturing and dispatch of first batch, received from the parent location or FDD of a new or existing product from a particular site with manufacturing, packaging and analytical details.
  • Master Product Specification (MPS):
    • The MPS most importantly have below information but not limited to the following,
    • ERP code for, Active pharmaceuticals ingredient (API), Excipients and Primary packing material/s.
    • Drug substance, excipients & primary packaging material sourcing.
    • Detailed Manufacturing formula along with bill of materials (BOM).
    • Precautions / Handling / Storage / Sampling details where ever required.
    • Brief manufacturing process.
    • Critical equipment list/critical process requirements.
    • Required utility/consumable list.
    • Information regarding tooling / change parts (size, shape, diagram /drawing).
    • Primary packing material specifications.
    • In-process specification and finished product specification.
    • Stability data and MSDS (API / Excipient / Finished product), Draft Label and Flow chart.

6.0       PROCEDURE FOR TECHNOLOGY TRANSFER:

  • Technology Transfer of New Product/ Transferred Product (Domestic):
    • FDD/ADD or Transferring location/Site transfer all the documents related to technology transfer of new batch/ transferred batch to the site.
    • Intimate the site QA for any additional document required and ensure the availability of the same.
    • After receiving the documents from the FDD/ADD or transferring location/site, QA officer make the necessary entries in the checklist for new / transferred product (Annexure 1) and
    • Issue it to all involved departments for checking of documents related to their concerned area.
    • All involved department check the technology transfer document and fill the checklist (Annexure-1) and returned it to the QA department.
    • QA executive / officer can also fill the check list for new product transfer in consultation with the concerned department heads.
    • QA executive / officer review the readiness / availability of documents.
    • Intimate for required precaution / measures in analytical method to site QC from ADD.
    • Ware house raise the purchase order for the raw material and packaging materials.
    • Tablets size,
    • Shape,
    • Quantity and
    • Type of tooling (B or D) for available tablet press.
    • Mention special precautions/features required for tooling in MPS if specified by FDD.
    • For example, lower punch with key and hard chrome platting on punches.
    • Production department / PDD order the capsules change parts as per the size and requirement by FDD along with MPS.
    • Packing department / PDD order the packing change parts as per the size and requirement by FDD along with MPS.
    • Once all raw materials, packing materials, change part, tooling and FDA permission for the product are received, FDD be informed for support to establish the manufacturing parameters.
    • Manufacturing BOM, MBMR, packing BOM, MBPR, Spec./ ATP of all respective products to be prepared prior to the manufacturing plan.
    • Make sure the availability of Raw material and packing material prior to the manufacturing plan.
    • Prior to the manufacturing of first batch (Issuance of BMR for first batch) of the product on site,
    • If required, first batch of new / transferred product manufactured in presence of FDD / transferring site Production personnel,
    • Therefore to know about the critical or key step as well as a precaution needed to be taken while manufacturing commercial batches.
    • Based upon the first three batches, Hence in case of any changes to be incorporated, FDD  revise the MPS and accordingly the MBMR / MBPR   prepared.
    • The stability sample is withdrawn by IPQA & perform stability study as per SOP of “Stability Program”.
    • For first three batches, an “Inspection report” most importantly  filled by packing officer and cross verified by IPQA officer.
    • Minimum 5 packed shippers checked for first three batches during its packaging.
    • After completion of packing process (during closure of BPR),Finally the batch release authorization for New Product filled by QA prior to the release of batches (For 1st three commercial batches).

6.0       ABBREVIATIONS:

  •  ADD : Analytical Development Department
  • API : Active Pharmaceutical Ingredient
  • BMR : Batch Manufacturing Record
  • BPR : Batch Packing Record
  • BOM : Bill of material
  • COA : Certificate of Analysis
  • CQ : Corporate Quality
  • ERP : Enterprise resources planning
  • FDA : Food and Drug Administration
  • FDD : Formulation Development Department
  • FMEA : Failure Mode Effect Analysis
  • LIMS : Laboratory Information Management System
  • MF : Master Formula
  • MFC : Master Formula Card
  • MPS : Master Product Specification
  • MSDS : Material Safety Data Sheet
  • PDD : Packaging Development Department
  • PIF : Project Information Form
  • PR : Purchase Requisition
  • QA : Quality Assurance
  • QC : Quality Control
  • R & D : Research and Development
  • RS : Reference Standard
  • SOP : Standard Operating Procedure
  • STP : Standard Test Procedure
  • WRS : Working Reference Standard

7.0      ANNEXURES

Annexure – 1

Checklist 1 of 3
Checklist 3 of 3

Annexure – 2

New Product Manufacturing Authorization

ProductDosage form
API Used

FOR COMMERCIAL PRODUCT

Sr. No.RequirementsAvailable Yes/ NoEnsured By (QA)Comments/ Commitments
1D.C.G.I. permission (If Applicable)
2F.D.A. Manufacturing License
3Excise formalities (if any).
4Raw material specification
5Packing material specifications
6Finish Product specification
7Batch manufacturing  record
8Batch Packing record
9Raw materials availability
10Packing materials availability
11Data on material safety, excipients handling or any critical controls for environment, storage and product (If any)
12Availability of accessories and machinery parts for manufacturing as well as packaging (punches, spares, etc.)       
13Analytical method
14Reagents, reference standards, working standards and impurity standards
15Process Validation Protocol, sampling  tools.
16Any other special requirement (……………………………………………)
17Any other special requirement (……………………………………………)

Based on the available data, we hereby authorize the product to be released for manufacturing subject to above criteria being satisfied.

DepartmentCommentsSign & Date
Warehouse Head
Manufacturing Head
Packing Head
QC Head
Engineering Head
EHS Head
Regulatory Affairs
Production Head
QA Head
Head Quality
Plant Head

Annexure – 3

New Product Packing Inspection Report

Technology Transfer of New Product