| Handling of Technology Transfer |
1.0 OBJECTIVE To lay down the procedure for technology transfer (TT) of new products intended to be manufactured at site. 2.0 SCOPE This procedure is applicable for receiving the technology of new product from formulation & development (F&D) department or technology transferring laboratory or marketing authorization holder (MAH). This procedure covers the TT for manufacturing method as well as analytical method of starting material and / or finished products wherever applicable. 3.0 RESPONSIBILITY • Head F&D / Project Coordinator • Department Head 4.0 ACCOUNTABILITY Head Quality / QA To Read this SOP Click Here SOP for Line Clearance. 5.0 PROCEDURE Technology transfer is a logical procedure that controls the transfer of an established process together with its documentation and professional expertise to manufacturing capable of reproducing the process and its support functions to a predetermined level of performance”. 5.1 TT of any new product shall be initiated by filling the “Technology Transfer Checklist” (Refer format No. XXX) and circulating it to concerned department for review & comments. 5.2 In case of products transferred from F&D lab, Head F&D shall initiate the checklist, in case of MAH products or technology transfer from other developmental lab, Project coordinator shall initiate the checklist & circulate it to concerned department, either project coordinator may be from production or quality assurance department. 5.3 TT of product shall be logged along with details mentioned (Refer Format No. XXX), by QA person. 5.3.1 Quality Assurance shall assign a TT No. to each TT product, as per prototype TT/YY/NNN, where: TT : stands for Technology Transfer. YY : stands for last two digit of calendar year (23 for 2023, 24 for 2024 etc.) NNN: stands for sequential serial no. of TT of product in the calendar year (001, 002, 003 ……) Example: First TT of product of year 2023 shall be numbered as TT/23/001. 5.4 F&D department / Project coordinator shall prepare / arrange for the required document as per the checklist and submit to QA department along with the TT checklist. If any of the documents is not available tentative dates for the availability of the same shall be provided. 5.5 Head QA shall forward the checklist to Quality Control (QC) department to ensure the availability of chemicals, reagents, columns and test methods are available. If any resource is not available, same shall be mentioned in TT checklist along with the status of raised indents. 5.6 After Quality Control checklist shall be sent to production department to ensure the availability of change parts, tools and necessary equipment for manufacturing & packing of product. Tentative Batch Manufacturing Record (BMR) shall be prepared on the basis of Master Formula record (MFR) prior to optimization / validation batch manufacturing by production. 5.7 After confirmation from manufacturing department, report shall be sent to PPIC to confirm the availability and / or procurement of all raw and packing material for manufacture and packaging of the product. 5.8 The batch planning shall be done as per the details provided by the technology transferring agency / F&D. 5.9 After manufacturing of exhibit / validation batches as per plan, the validation report shall be reviewed to assess the manufacturing procedure for its consistency & reproducibility. The technology transfer of product stands successful if the manufacturing procedure is found consistent & gives reproducible results. 5.10 The samples shall be kept under custody of QA department. 5.11 On receipt of samples, the covering letters of samples shall be archived. 5.12 When any samples are sent outside for bio-equivalence study to any study center the covering letter, sample details, courier details, non-returnable gate pass shall be prepared and archived. 5.13 Discontinuation of Product from Site: 5.13.1 The manufacturing of product may be discontinued due to following reason but not limited to; • The contract acceptor is not interested in its continuation. • The contract giver is not interested in its continuation. • The product is not stable and failed in the stability study. 5.13.2 After getting comment from Executive or above QA, discontinuation form shall be forward to Head Plant for comment and authorization. 5.13.3 After getting comment from Head Plant, QA officer shall forward the discontinuation form to Head QA for comment & approval. If required Head QA shall forward the discontinuation form to Pl Holder for information or approval. 5.13.4 Head QA shall decide the proposed action on documents and other related section as per product discontinuation form format No XXX. 5.13.5 After getting approval from Head QA, QA officer shall forward the discontinuation form to relevant department for their reference. 5.13.6 After getting comment from respective department, the discontinuation form shall be forward to Head QA for closure. 5.13.7 Head QA shall check the closure requirement and if found satisfactory shall close discontinuation form. 5.14 QA officer after closure shall update the product discontinuation log. Discontinuation form shall be retained till existence of facility. 5.15 Review of Technology Transfer Status: 5.15.1 Technology transfer status shall be reviewed by QA personnel on quarterly basis as per Format NO. XXX. In case of any product, technology transfer was initiated but product was not transferred at site then technology transfer of that product shall be cancelled and same shall be updated on technology transfer review status (Format No.: XXX) & technology transfer log. |