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 ByCreated OnUpdated ByUpdated On
CMN -0001-2526/02/2025BDPermanent MinorLaunch of New Products in Afghanistan.Products mentioned in the attached list are not launched in Afghanistan yet.These products are planned for launch in Afghanistan. N/AApproved31/05/2025In ProgressNutra1)Product Launch in Afghanistan. BD 2)FG codes will be opened. SCM 3) BOM will create on SAP. QA 4) BPR will be prepared. QA 1)May-25 2)Apr-25 3)May-25 4)May-25 Hamza Ahmed 26/02/2025Hamza Ahmed 20/04/2025
CMN -0002-25 08/04/2025PDPermanent MajorNew launch product Kalsob-M sachet.Product development activities of generic red algae calcium 1400mg+Vitamin K2 90mcg +Vitamin D3 10mcg+ Magnesium 32mg Sachet has been completed.It is proposed to commercialize generic red algae calcium 1400mg+Vitamin K2 90mcg +Vitamin D3 10mcg+ Magnesium 32mg Sachet in pharmevo facility.RA-0015-25Approved In ProgressNutra01) Trail documents are required. PD 02) Stability study documents are required. PD 03) Technology transfer protocol (for process) is required. PD 04) Technology transfer protocol (for analytical testing) is required. PD 05) Regulatory approval required before commercialization. RA 06) Source approval documents are required. SCM 07) Procurement of red algae calcium raw materials. SCM 08) Artwork will be developed and approved. BD 09) Item codes will be opened for new developed artwork. BD 10) FG codes will be opened. SCM 11) Procurement of packaging material. SCM 12) Analytical testing method will prepared and update on LIMS. QC 13) BOM will be create in SAP. QA 14) Batch documents (BDR, BMR, BYS, and BPR) will be prepared. QA 15) Routing will be create in SAP. Production 16) Planning of product launch for commercial. BD 17) Process validation will be performed. QA(Val) 18) Product will be charge on stability. QC 1) Oct-25 2) Oct-25 3 Oct-25 4) Oct-25 5) Oct-25 6) July-25 7) Sep-25 8) Oct-25 9) Oct-25 10) Aug-25 11) Nov-25 12) Nov-25 13) Nov-25 14) Nov-25 15) Dec-25 16) Dec-25 17) July-26 18) Aug-26 Hamza Ahmed 14/04/2025Hamza Ahmed 19/08/2025
CMN -0003-2507/05/2025BDPermanent MinorLaunch of New Products in Uzbekistan.The products mentioned in table is not launched in Uzbekistan yet. S.No 01 Product Femova Sachet Generic Myoinositol + D-Chiroinositol + Quatrefolic Pack Size 10's Shelf Life 24 months Registration Timeline Jun-25 Pack size in Local 10's (For reference only)This product is planned for launch in Uzbekistan. under Approval  Nutra Hamza Ahmed 07/05/2025Hamza Ahmed 08/05/2025
CMN -0004-2522/05/2025ProductionPermanent  Installation of 200Kg double cone blender in production nutraceutical buildingCurrently we have 100kg double cone blender in production nutraceutical buildingIt is proposed to install another 200kg double cone blender nutraceutical buildingN/Aunder Approval  Nutra Hamza Ahmed 22/05/2025  
CMN -0005-25 23/05/2025BDPermanent  Launch of new product in KyrgyzstanThe product mentioned in the attached list are not launch in Kyrgyzstan.These products are planned to be launched in Kyrgyzstan.N/Aunder Approval  Nutra Hamza Ahmed 23/05/2025  
CMN -0006-25 23/05/2025BDPermanent  Launch of Additional Pack Size of Product in Tajikistan.The below mentioned product is already launched in the mentioned pack size in Tajikistan. S.No : 01 Product : Femova Sachets Generic : Myoinositol 1100mg + D-Chiroinositol 300mg + Folate 600 mcg as (6S)-5-MTHF Pack Size : 1x10's Shelf Life : 24 Months Registration Timeline : Registered It is proposed to Launch below product in mentioned pack size in Tajikistan. S.No : 01 Product : Femova Sachets Generic : Myoinositol 1100mg + D-Chiroinositol 300mg + Folate 600 mcg as (6S)-5-MTHF Pack Size : 3x10's Shelf Life : 24 Months Registration Timeline : Registered N/Aunder Approval  Nutra Hamza Ahmed 23/05/2025  
CMN -0007-25 23/05/2025QAPermanent  Incorporation of a Precautionary Statement "Do not handle the tablets with wet hands" on SheVit Tablets Packaging Components. Currently, the packaging components of SheVit Tablets (carton, label, and leaflet) do not include any precautionary statement advising users on the proper handling of the tablets to prevent physical degradation due to moisture exposure.Addition of the following precautionary statement to the packaging components (carton, label, and leaflet) of SheVit Tablets: • English : Do not handle the tablets with wet hands • Urdu : ?????? ?? ???? ?????? ?? ?? ?????? N/Aunder Approval  Nutra Hamza Ahmed 23/05/2025  
CMN -0008-25 23/05/2025SCMPermanent  Additional source induction of VITAMIN C (ASCORBIC ACID) COATED 97%We are currently procuring Excipient: Vitamin C (Ascorbic Acid) Coated 97% from SUPREEM PHARMACEUTICALS MYSORE PVT LTD, INDIAWe intend to induct one more source M/s. LUWEI PHARMACEUTICAL GROUP CO LTD. Add: SHUANGFENG INDUSTRIAL PARK, ZICHUANDISTRICT, ZIBO CITY SHANDONG, CHINAN/Aunder Approval  Nutra Hamza Ahmed 24/05/2025  
CMN -0009-25 29/05/2025ProductionPermanent  Increases in Batch sizes of productsCurrently, the following products are available in different batch sizes, but they are not sufficient to meet market demand.It is proposed to increase the batch sizes of products mentioned below: 1 Kalsob tablet. 2. K-1000 Chewable tablet. 3. Ferfer sachet. Detailed document is attached with details related to number of lots, increased batch size and equipment. N/Aunder Approval  Nutra Hamza Ahmed 29/05/2025  
CMN -0010-25 29/05/2025ProductionPermanent  Inclusion of primary packaging material (A/F) in Manufacturing Orders for Sachet Products (Nutraceutical Sachet Area). Currently, the primary packaging material (Aluminum foil) for sachet products are part of the Packaging Order process. A/F is issued after the completion of the manufacturing process.It is proposed to include the primary packaging material (Aluminum foil) into the Manufacturing Order, aligning the Aluminum Foil issuance with the dispensing of raw materials. Dispensing procedure will remain same for raw and packaging material.(List of sachet product is attached)N/Aunder Approval  Nutra Hamza Ahmed 29/05/2025  
CMN -0011-25 24/06/2025QCPermanent  Reduce testing for Nutraceutical product (Shevit)      Nutra Hamza Ahmed 25/06/2025  
CMN -0012-25 30/06/2025QAPermanent  Weighing Balance      Nutra Hamza Ahmed 30/06/2025  
CMN -0013-25 04/09/2025PDPermanent MajorChange in Coating material of SheVit Tablet.Currently, Insta Moistshield White Aqua II is being utilized as the film coating material. This material was initially introduced as an alternate source in place of Opadry AMB II. However, maintaining a consistent inventory has become challenging, due to its Indian origin and current going political situation in the region.It is proposed to replace Insta Moistshield White aqua II with Opadry AMB II as the coating material. Addition of colorant in seal coating stage. Increase in the percentage weight gain of the tablets during both coating stages. Approved  Nutra Hamza Ahmed 11/09/2025Hamza Ahmed 12/09/2025
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2024-2025 QA.