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
- 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 .
- SOP for Risk Management
- SOP for Stability Program
- Analytical Method Transfer procedure
- WHO Guidance on Tech Transfer
- Change Control Procedure
- 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.
- 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.
- 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,
- 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).
- 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
Annexure – 1
Annexure – 2
New Product Manufacturing Authorization
FOR COMMERCIAL PRODUCT
|Sr. No.||Requirements||Available Yes/ No||Ensured By (QA)||Comments/ Commitments|
|1||D.C.G.I. permission (If Applicable)|
|2||F.D.A. Manufacturing License|
|3||Excise formalities (if any).|
|4||Raw material specification|
|5||Packing material specifications|
|6||Finish Product specification|
|7||Batch manufacturing record|
|8||Batch Packing record|
|9||Raw materials availability|
|10||Packing materials availability|
|11||Data on material safety, excipients handling or any critical controls for environment, storage and product (If any)|
|12||Availability of accessories and machinery parts for manufacturing as well as packaging (punches, spares, etc.)|
|14||Reagents, reference standards, working standards and impurity standards|
|15||Process Validation Protocol, sampling tools.|
|16||Any other special requirement (……………………………………………)|
|17||Any other special requirement (……………………………………………)|
Based on the available data, we hereby authorize the product to be released for manufacturing subject to above criteria being satisfied.
|Department||Comments||Sign & Date|
Annexure – 3