Ref. SOP No. QAG/2/033

PHARMEVO (PVT.) LTD.

Document No. QAG/5/088

Title: New Change Management Log Book - Nutra


 
 CRF NoCRF Receiving DateDepartmentTypeCategoryTitle of ChangeExisting SituationProposed ChangeRA NoProposed Change StatusIntended Date Of Impl.Completion StatusCategory AreaActionsActionsTrackingTimelinesCreated OnUpdated OnCreated ByUpdated By
CMN-0001-2409/01/2024SCMPermanent Major Additional source induction | MyoinositolWe are currently procuring nutraceutical material Myoinositol from M/s. Zouping Xiwang Bioengineering co ltd China.we intend to induct one more source M/s SICHUAN BOHAODA BIOTECHNOLOGY CO LTD ADD: NO.9 LONGXIANG AVENUE, HIGH-TECH INDUSTRIAL PARK, Zigong city, sichuan, ChinaN/AApproved 30/01/2026OpenedNutra1) specification agreement required 2) PD trial required 3) Trial batch stability report required 4) valid GMP certificate from country of origin. 6) valid DML required 7) Halal certificate required 8) quality agreement required 9) vendor list will be updated. 10) procurement of material for commercial batches. 11) process validation will be performed 12) product will charge on stability. 09/01/202420/02/2024Hafsa FatimaHafsa Fatima
CMN-0002-2416/01/2024SCMPermanent Major Additional source induction | Simethicone Emulsion 30%We want to procure '' Simethicone Emulsion 30%'' for our nutraceutical product Evojoshanda sachet. we intend to induct this source M/s Nitika pharmaceutical specialties pvt ltd Add: Block No: 03 of plot no: 1296, 1297/08, ward no 03, Mouza-Waddhamna Tah-Hingna, Amravati road, Nagpur 440023, india for the material simethicone Emulsion 30%N/AApproved 29/02/2024OpenedNutra1) Specification agreement will be signed before approval of the source. 2) Sample testing report is required. 3) DMF will arrange. 4) PD Trial on new source is required with Stability studies report. 5) Valid DML is required. 6) Valid GMP certificate from country of origin. 7) Quality agreement is required. 8) Supplier Questionnaire form will be developed to receive the required information. 9) List of approved supplier/materials will be developed and circulated to all concerns departments. 10) Strength with amount of material required for process validation. 11) Procurement of material to conduct commercial batch manufacturing. 12) Planning of batches to be taken for process validation on new source 13) Process validation will be performed. 14) Stability of product will be charged. 16/01/202426/03/2024Hafsa FatimaHafsa Fatima
CMN-0003-2404/03/2024Business Development PermanentMajorLaunch Of New product in Kazakhstan The product is mentioned in the attached list are not launch in Kazakhstan 1) Ferfer sachet 2) Reklaim sachet 3) Adfolic tablet These products are planned for launch in Kazakhstan N/AApproved  OpenedNutraProduct launch in Kazakhstan 2. Development and approval of artwork QC PKG 3. Regulatory approval required RA 4. Item code will open for new developed artwork QC PKG 5. FG codes will be opened SCM 6. Specification will be updated QC PKG 7. BOM will create on SAP QA 8. BPR will be prepared QA 1-APR-2024 2-APR-2024 3-MAR-2024 4-APR-2024 5-MAR-2024 6-JUL-2024 7-MAY-2024 8-MAY-2024 04/03/202422/04/2024Hafsa FatimaHafsa Fatima
CMN-0004-2425/03/2024SCMpermanentmajorAdditional source induction of D-chiro Inositolwe are currently procuring nutraceutical material D- Chiro inositol from M/s.BIO SEARCH S.Awe intendto induct one more source M/s M/s hebei amino biotechnology Co.,Ltd, Add; East Huangguan Rd; North Huigong Ave., Qinghe Auto and Motor Industrial area, Xingtai City, Hebei Province, P.R. China / 054800N/AApproved30/06/2025OpenedNutra1. Source approval documents are required along with all the technical documents SCM 2. Approved vendor list will update QA 3. Procurement of material to conduct commercial batch manufacturing SCM 4. Process validation will be performed QA 5. Stability of product will be charged QC 6) LIMS will be updated 1) April-2024 2) April-2024 3) April-2025 4) June-2025 5) June-2025 6) June-2025 27/03/202424/04/2024Hafsa FatimaHafsa Fatima
CMN-0005-2425/03/2024SCMpermanentmajorAdditional source induction of Vitamin D3 We are currently procuring Nutraceutical material Vitamin D3 powder 100,000 IU/g from M/s. DSM nutritional product and Zhejiang garden biochemical high tech Co Ltd. Moreover, we have item description with brand name i-e Vitamin D3 powder 100 SDS (DRY)we intent to induct one more source M/s Xiamen kingbomway biotech Co., Ltd.No.299 west Yangguang road, Haicang, Xiamen, China Moreover, we propose to change item description from vitamin D3 powder 10SDS (DRY) to Vitamin D3 powder 100,000 IU/gN/AApproved OpenedNutra1. Source approval documents are required along with all the technical documents SCM 2. Approved vendor list will update QA 3. Procurement of material to conduct commercial batch manufacturing SCM 4. Process validation will be performed QA 5. Stability of product will be charged QC 27/03/2024 Hafsa Fatima 
CMN-0006-2429/05/2024Business Development Permanent Major Revision in artworks of Sparliv Tablets & Vible Tablets1. Existing artworks of Sparliv & Vible does not contains statement regarding desiccant bag. 2. Storage conditions on existing artworks are mentioned as "Store below 30°C1. This statement will be added on artworks of Sparliv & Vible "Always keep the desiccant bag inside the bottle" has been added. 2. Storage conditions will be updated to "Store below 25°C".N/AApproved 28/06/2024OpenedNutra 29/05/2024 Hafsa Fatima 
CMN-0007-2428/06/2024Product DevelopmentPermanentMajorChange in formulation of Finno-Q SachetCurrently, formulation of Finno-Q sachet contains coated ascorbic acid.Complete formulation is attached in annexure-1.It is proposed to remove coated ascorbic acid and add citric acid anhydrous as per formulation attached in annexure-1.RA-0028-24Approved OpenedNutra 28/06/2024 Zafran Meer 
CMN-0008-2412/07/2024SCMPermanentMajorDiscontinuation of Flavor Orange Durarome 861994 TD 0991 and development of alternate sourceCurrently we have approved Flavor Orange Durarome 861994 TD 0991 for Nutraceutical products (list of products attached) from Manufacturer M/S. DSM Firmenich.Development of alternate source of flavor with another product code i.e Orange Durarome Flavor 858024 TDB 0594 with same specification and Manufacturer M/S. DSM Firmenich. Sample has been submitted and PD trial and initial test results have been approved.    In ProgressNutra 12/07/2024 Zafran Meer 
CMN-0009-2403/08/2024BDPermanent MajorNew products launch in GhanaThe below mentioned products are not launched in Ghana yet. 1. Ferfer Sachets 2. Evomag SachetIt is proposed to launch these products in Ghana. N/AApproved In ProgressNutra1) Registration Letter required RA 2) Product launch in ghana. BD 3) Development and approval of artwork BD 4) Item code will open for new developed artwork QC 5) FG codes will be opened SCM 6) Specification will be updated QC 7) BOM will create on SAP QA 8) BPR will be prepared QA 9) Shelf life for export product list will be updated. QA 1) Registration letter received for both products. 3) Development and approval of artwork for both products. 4) Item codes is opened for both products. 5) FG codes is opened for both products. 7) BOM has been created for both products. Timelines for ferfer sachet: 1) Already registered 2) Oct-24 3) Done 4) Done 5) Sep-24 6) Dec-24 7) Dec-24 8) Dec-24 9) Jan-25 Timelines for Evomag Sachet: 1) Already registered 2) Dec-24 3) Aug-24 4) Aug-24 5) Sep-24 6) Dec-24 7) Dec-24 8) Dec-24 9) Jan-25 0 03/08/202418/11/2024Hamza Ahmed Hamza Ahmed
CMN-0010-2403/08/2024BDPermanent MajorNew Products launch in TajikistanThe products mentioned in the attached list are not launched in Tajikistan.It is proposed to launch these products in Tajikistan.N/AApproved In ProgressNutra1) Registration Letter required RA 2) Product launch in Tajikistan. BD 3) Development and approval of artwork BD 4) Item code will open for new developed artwork QC 5) FG codes will be opened SCM 6) Specification will be updated QC 7) BOM will create on SAP QA 8) BPR will be prepared QA 9) Shelf life for export product list will be updated. QA 3) Artwork has been developed for all five products. 4) Items codes has been opened for all five products. 5) FG codes has been opened for all five products. 7) BOM has been developed for all five products. Timelines are same for all products: 1) Dec-24 2) Dec-24 3) Aug-24 4) Aug-24 5) Sep-24 6) Mar-25 7) Dec-24 8) Dec-24 9) Jan-25 03/08/202418/11/2024Hamza Ahmed Hamza Ahmed
CMN-0011-2409/10/2024BDPermanent  Launch of New Products in UAE.The products mentioned in the attached list are not launched in UAE yet.These products are planned for launch in UAE.N/Aunder Approval  Nutra 09/10/2024 Hamza Ahmed  
CMN-0012-2409/10/2024BDPermanent  Launch of New Products in Qatar.The products mentioned in the attached list are not launched in Qatar yet.These products are planned for launch in Qatar.N/Aunder Approval  Nutra 09/10/2024 Hamza Ahmed  
CMN-0013-2409/10/2024BDPermanent  Launch of New Products in EthiopiaThe products mentioned in the attached list are not launched in Ethiopia yet.These products are planned for launch in Ethiopia.N/Aunder Approval  Nutra 09/10/2024 Hamza Ahmed  
CMN-0014-2401/11/2024SCMPermanent  Addition of Manufacturer Name for Tribasic calcium phosphateWe have approved Supplier by the name of M/s JRS Pharma GmbH & Co. KG for Nutra Excipient Tribasic calcium phosphate which is getting Toll Manufactured by Sudeep Pharma Pvt Ltd We intend to Procure Tribasic calcium phosphate with same Specifications directly from Sudeep Pharma Pvt Ltd and propose to add Sudeep Pharma Pvt Ltd in Nutra Vendor List. Sudeep Pharma Private Limited, Address: 129/1/A & 129/12, 13, 14, 15 GIDC Estate, Nandesari-391340, Vadodara, Gujarat, India N/Aunder Approval In ProgressNutra 02/11/202402/11/2024Hamza Ahmed Hamza Ahmed
CMN-0015-2401/11/2024PDPermanent  Change in formulation of K-1000 Chewable Tablet.Currently, K-1000 Chewable Tablet is being manufactured by Calcium Carbonate 92.5%, Xylitab 200 and Aspartame as per the formulation attached in annexure I.It is proposed to replace Calcium carbonate (92.5%) and aspartame with Calcium carbonate (95%) and sucralose, respectively. Additionally, mannitol (Pearlitol) will be incorporated as mentioned in the formulation attached in Annexure I.N/Aunder Approval In ProgressNutra 02/11/2024 Hamza Ahmed  
CMN-0016-2405/12/2024PDPermanent  Change in formulation and revised artwork of Femova Sachet. Currently, Femova Sachet is being manufactured as per the formulation attached in annexure I.It is proposed to revise formulation of Femova Sachet by replacing citric acid and sodium citrate with ascorbic acid and aspartame with sucralose. Butylated hydroxyanisole is also added in formulation as mentioned in Annexure I. Orange Durarome Flavour 858024TDB0594 will be used with 20% less quantity as per CMN-0008-24. Artwork to be revised mentioning storage condition as “Store below 25?.”  under Approval  Nutra 05/12/2024 Hamza Ahmed  
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2024-2025 QA.