challenges of biological drug registrationinvietnam and suggesting for improving registration process in a local pharmaceutical company

HO CHI MINH CITY OPEN UNIVERSITY UNIVERSITÉ LIBRE DE BRUXELLES SOLVAY BRUSSELS SCHOOL OF ECONOMICS & MANAGEMENT MBQPM5 “NGUYEN NHU TRANG” “CHALLENGES OF BIOLOGICAL DRUG REGISTRATION IN VIETNAM AND SUGGESTING FOR IMPROVING REGISTRATION PROCESS IN A LOCAL PHARMACEUTICAL COMPANY” MASTER FINAL PROJECT MASTER IN BUSINESS QUALITY AND PERFORMANCE MANAGEMENT Ho Chi Minh City (2016) HO CHI MINH CITY OPEN UNIVERSITY UNIVERSITÉ LIBRE DE BRUXELLES SOLVAY BRUSSELS SCHOOL OF ECONOMICS & MANAGEMENT MBQPM5 “NGUYEN NHU TRANG” “CHALLENGES OF BIOLOGICAL DRUG REGISTRATION IN VIETNAM AND SUGGESTING FOR IMPROVING REGISTRATION PROCESS IN A LOCAL PHARMACEUTICAL COMPANY” MASTER FINAL PROJECT MASTER IN BUSINESS QUALITY AND PERFORMANCE MANAGEMENT Tutor: Jacques Martin Ho Chi Minh City (2016) HO CHI MINH CITY OPEN UNIVERSITY UNIVERSITÉ LIBRE DE BRUXELLES SOLVAY BRUSSELS SCHOOL OF ECONOMICS & MANAGEMENT MBQPM5 “NGUYEN NHU TRANG” “CHALLENGES OF BIOLOGICAL DRUG REGISTRATION IN VIETNAM AND SUGGESTING FOR IMPROVING REGISTRATION PROCESS IN A LOCAL PHARMACEUTICAL COMPANY” MASTER FINAL PROJECT MASTER IN BUSINESS QUALITY AND PERFORMANCE MANAGEMENT Tutor: Jacques Martin Ho Chi Minh City (2016) ACKNOWLEDGEMENTS Firstly, I would like to acknowledge the support of Prof Jacques Martin who gave me strength, encouragement and his kind input and re-sharpening of my ideas Special appreciation is also expressed to all Drs and Professors from the Master In Business Quality And Performance Management program, for their professional advice on data collection, review and methodology that truly supporting for final report writing I also extend my gratitude to DAV Officers, specifically the Director of the Drug registration Department, Mr Chu Dang Trung, for approving for me to purse the data collection and follow – up interview, and the whole Department of Medicines Registration for their material support during data collection I extend my gratitude to pharmacist in-charge and evaluators for devoting their time cooperation given during data collection I specially acknowledge the HL Pharma company, the Executive Management team, and Head of R&D department, for accepting this work to be done supported me academically and materially during this final report preparation I also extend my gratitude for the moral support and assistance from my colleagues in the MBQPM5 class during times academically Finally, I would like to send my deep gratitude to my family for all of their supports and encouragements ACCEPTANCE OF FINAL PROJECT REPORT FOR DEFENSE Mr/Ms NGUYEN NHU TRANG’s final project report for the degree of Master in Business Quality and Performance Management is officially accepted for defense On 14 April 2016 Dr Jacques M.A Martin Academic Director Master in Business Quality and Performance Management Solvay Brussels School of Economics and Management – Ho Chi Minh City Open University TABLE OF CONTENT INTRODUCTION 11 1.1 BACKGROUND 11 1.2 PHARMACEUTICAL MANAGEMENT SYSTEM 12 1.3 HL PHARMA 12 1.4 HISTORY OF REGISTRATION IN VIETNAM 13 1.5 GENERAL DESCRIPTION OF REGISTRATION PROCESSES 14 1.5.1 Drug regulation process 14 1.5.2 Key players and tasks in drug registration 15 1.5.3 Regulatory affairs department 15 1.6 Drug registration process in HL Pharma 16 PART 1: METHODOLOGY 18 Chapter REGULATORY FRAMEWORK 18 2.1 Legislative in harmonization trends 18 2.1.1 ICH hamonization 18 2.1.2 ASEAN Harmonization strategy 19 2.1.3 ASEAN Harmonization in Vietnam 20 Chapter METHODS AND MATERIALS 21 3.1 Study Design 21 3.2 Study participants 21 3.3 Study Period 21 3.4 Sampling technique 21 3.4.1 For identification the challenges of medicines registration process in Vietnam 21 3.4.2 To determine the need of good registration process in HL Pharma 22 3.5 Data Collection 22 PART 2: ANALYSIS AND REVIEW 23 Chapter RESULTS 23 Socio-demographic information of participants 23 4.2 Companies represented, and their number of biological products registered 24 4.2.1 Companies represented 24 4.2.2 Time taken for dossier registration approval 25 4.2.3 Time taken for dossier registration preparation 25 4.3 Assessment of knowledge with regards to medicines registration 26 4.4 Practice among DAV evaluators on medicines registration 27 Chapter 2: ASSESSMENT OF CHALLENGES IN DRUG REGISTRATION PROCESSAND REVIEW 29 5.1 Challenges encountered by evaluators (21) 29 5.2 Challenges encountered by representatives of manufacturer (40) 31 REVIEW CURRENT QUALITY MANAGEMENT IN HL PHARMA 32 6.1 GDP system in HL Pharma 32 6.2 Registration system in HL Pharma 33 6.2.1 The current role of regulatory activities within HL Pharma 33 6.2.2 Improve the registration process 34 CONCLUSION AND RECOMMENDATIONS 38 7.1 CONCLUSION 38 7.2 RECOMMENDATIONS 38 REFERENCES 42 LIST OF ABRIVIATIONS AND/OR SYMBOLS ASEAN Common technical dossier ACTD Balance scorecard BSC Drug administration of Vietnam DAV EMEA Europe, the Middle East and Africa countries ICH The International Conference on Harmonisation Good Distribution Practice GDP Good Storage Practice GSP Quality Management System QMS Regulatory affairs RA Research and development R&D LIST OF FIGURES, TABLES AND ANNEXES Figure: Figure 1: Pharmaceutical Management system 12 Figure 2: Reason of delay in DAV registration process 30 Figure Reason of delay in registration process (encountered by Pharmacist-in-charge) 31 Figure 4: The plan–do–check–act cycle……… …………………………… ……… 34 Table Table 1: ACTD harmonization in drug registration guidelines from 2009-2015 20 Table 2: Socio-demographic characteristics of medicine evaluators (n=21) 23 Table 3: Socio-demographic characteristics of pharmacists’ in-charge of pharmacies (n=45) 24 Table 4: Local companies distribution in relation to companies represented, and dossiers applications registered (n=25) 24 Table 5: Time taken for dossier registration preparation in HL Pharma 26 Table 6: Proportion of evaluators’ knowledge assessment in relationship to the correct responses 26 Table 7: Summary of responses to practice on medicines registration among evaluators 28 Table 8: Challenges encountered by evaluators (n=21) 29 Table 9: Challenges encountered by representatives of manufacturer (n=40) 31 Table 10: Assessment and overview of the current drug regulatory situation in the company 35 Annex Annex 1_Questionaires to Evaluators_Pharmacist Annex 2_DAV Regulatory_Process_VIETNAM Annex 3_2016-02 BSC_RA HL Pharma Annex 4_Estimated registration time Annex 5_Regulatory Roadmap 2016_Template Annex 6_Proposed drug registration Procedure Doc code Product registration procedure HOANG LONG PHARMA Role/Function Technical Approver (Manufacturer QA/TA) Ver.: 02 Eff date: Page x x x : PTKD_02 1.6.2016 : 5/1 Responsibility Review registration content to verify that all registration requirements are included in the final CTD for submission Review and approve physical requirements of the final CTD for submission Approve the final CTD for submission CONFIDENTIAL - INTERNAL USE ONLY REV Doc code Product registration procedure HOANG LONG PHARMA 4.0 : PTKD_02 Ver.: 02 Eff date: Page 1.6.2016 : /1 PROCESS Phase Step TRIGGER STA Receive request for drug RT registration INITIATION (CHANGE CONTROL) ESTABLISH CONTENT Action Initiate change control for drug registration x Initiate change control per the change control process Responsible (Performed by) Output Head R&D Product Registration Roadmap – Pre-launch Head R&D Tender project manager Initiated change Content Owner x Registration requirements Compile registration / Project requirements compiled manager x Determine the types of x Registration requirements registration impacted or Specification, list of needed documentation compiled and applicable x Determine the appropriate registration stakeholders for x Registration and relabeling a CFT based on the type of requirements (design applications inputs) being created, added, edited, or removed x Work with CFT and Project are drafted owner(s) to determine the applicable registration and relabeling requirements (e.g., content, technical, physical requirements) Develop registration content Content Coordinator and create CTD template x Create template x Review with CFT to ensure output and registration timeline meets requirements CTD dossier developed CONFIDENTIAL - INTERNAL USE ONLY REV Doc code Product registration procedure HOANG LONG PHARMA Phase ANALYSIS (CHANGE CONTROL) PLANNING & APPROVAL (CHANGE CONTROL) Action CONTENT SUPPLEMENT TEMPORARY LICENSE Eff date: Responsible (Performed by) Project manager HL R&D Obtain impact assessments x Facilitate required assessments for the registration change per the change control process x Registration timeline is assessed to ensure supply and business continuity Obtain approval of registration submission content and obtain translations (if applicable) HL R&D Create change plan for registration; manage/drive change through change control process HL R&D Logistic manager Tender Manager HL R&D Manufacturer RA Submission x Develop CTD content for submission x Obtain 100% proofread for submission Obtain Health Authority (DAV) approval 7.1 Obtain Health Authority (DAV) enquiries Supplement x Develop CTD content for subpplement x Obtain 100% proofread for submission CONTENT APPROVAL Ver.: 02 Page Step 7.2 Obtain Health Authority (DAV) approval Work with CFT and Project owner(s) to determine the relabeling requirements : PTKD_02 HL R&D HL R&D 1.6.2016 : /1 Output x Completed change Initiation record x Completed assessments x Approved registration content required in CTD template for submission x Approved translations, if required for submission Change plan developed Supply plan and business continuity Updated RA Roadmap Record and documentation per process Archieving hard copy, soft copy if required Completed submission and DAV approval Completed submission and DAV approval Record and documentation per process Archieving hard copy, soft copy if required HL R&D Manufacturer RA Logistic manager CONFIDENTIAL - INTERNAL USE ONLY REV Doc code Product registration procedure HOANG LONG PHARMA Phase LABELING DEVELOPMENT Ver.: 02 Eff date: Page Step Action Create final artwork Create final artwork based on approved labeling content and labeling specification DESIGN OUTPUTS (DESIGN CONTROL) : PTKD_02 Responsible (Performed by) 1.6.2016 : /1 Output Manufacturer QA/TA Labeling Design & Development Final artwork created Complete updates, as needed, including, but not limited to, requirements, outputs (e.g., specifications, labeling), and Verification and Validation activities Perform design review and update Technical Documentation, as needed Manufacturing x Released Labeling /Drug specification Requirements for the proposed changes x Verification Plan and Validation Plan and Results for the proposed labeling, as needed x Updated Drug master file and drug registration elements issued FINAL APPROVAL (First Of Batch) Obtain final artwork / release specificaton approvals 200% proofread Labeling Design & Development HL R&D Approved proofread artwork/ release specificaton RELEASE (NEW LABELING & DRUG SPECIFICATION) 10 Issue approved labeling/drug specification Labeling Design & Development Issued labeling/drug specification 11 Provide artwork and specification (if applicable) to print supplier/manufacturing Labeling Design & Development Artwork and specification provided to supplier/ manufacturing 14 Manufacturing, Approved labeling/drug Implement (First HL R&D specification implemented Use/Article/First of Code) on product Refer to tender & supply plan Logistic Manager DMR / Technical Implement Drug Master Documentation elements Record (DMR)/Technical implemented Documentation IMPLEMENTATION CONFIDENTIAL - INTERNAL USE ONLY REV Doc code Product registration procedure HOANG LONG PHARMA Phase Ver.: 02 Eff date: Page Step 15 Action Coordinate obsolescence of labeling/drug specification per change plan : PTKD_02 Responsible (Performed by) Labeling Design & Development 1.6.2016 : /1 Output x Superseded labeling obsolesced x DMR updated CONFIDENTIAL - INTERNAL USE ONLY REV Doc code Product registration procedure HOANG LONG PHARMA Ver.: 02 Eff date: Page 5.0 GENERAL REQUIREMENTS 5.1 Registration Requirements Repository : PTKD_02 1.6.2016 : 1/1 A collaborative repository of known registration and labeling requirements shall be used to compile Vietnamese regulations 5.2 Drug specification x 5.3 Labeling Part Number Identification x x 5.4 x All labeling must have a labeling specification Labeling components (artwork, electronic artwork files, labeling specifications, etc.) must be controlled Drug Master record components (hardcopy, electronic registration files, labeling specifications, etc.) must be controlled Labeling for New Product Development x 5.7 The labeling part number must appear on the final artwork and on the final printed labeling materials or be affixed to the label printing die/plate, roll, or label liner area Control x 5.6 All new and all revised labeling with artwork must be assigned a unique labeling part number Labeling Specification x 5.5 All new and all revised drug specification must be assigned a unique specification part number Change control requirements for labeling for new product development is excluded unless a change is made after the first regulatory submission or after the DMR/Technical Documentation is approved Proofreading (final document) x x x A 200% proofread (i.e., a verification by two people) must be performed on the content of all registration content prior to final approval A 100% proofread is acceptable on translations and/or when automated, validated, proofreading systems are used The method of proofreading used is at the discretion of the individual facility/function Proofreading approvals must be documented CONFIDENTIAL - INTERNAL USE ONLY REV Doc code Product registration procedure HOANG LONG PHARMA 5.8 Ver.: 02 Eff date: Page 1.6.2016 : 1/1 Approvals x x 6.0 : PTKD_02 Minimum required approver(s) of final registration content is a Technical Approver; minimum required approver(s) of labeling specifications are Quality Approver and Technical Approver Evidience approvals must be documented DEFINITIONS Term Definitions Issued Labeling The process of making final, approved labeling artwork available for use (e.g., publishing the labeling and labeling specification into a data/document management system) CTD Registration data in common technical format consists of all labels and other written, printed, graphic or electronic registration information matter which is affixed to a product or any of its containers or wrappers, or accompanying a product at any time, and is related to identification, technical description and use of the product Labeling Content Content of labeling consists of text, tables, and figures and may also include graphics, images, and other elements such as barcodes, illustrations, logos, photographs, charts, symbols, and anti-counterfeit features Labeling Specification Labeling specifications can include: engineering drawing and/or artwork for labeling, appropriate inspection or control procedures, and appropriate physical requirements Proofreading The process of manually and/or electronically comparing the text and graphics of an input document against an output document (e.g., final artwork), and identifying differences Relabeler Clear written record of relabeling requirements and content being created, added, edited, or removed for temporary licenses to facilicate supply continuity CONFIDENTIAL - INTERNAL USE ONLY REV Doc code Product registration procedure : PTKD_02 Ver.: 02 Eff date: HOANG LONG PHARMA Page 1.6.2016 : 1/1 CHANGE INFORMATION DCR/CP Number: Local Change Request Number: N/A Description of Change NEW DRUG REGISTRATION DEVELPMENT PROCESS Reason for Change Drug registration develpment is new registration process resulting from redesign under the registration process improvement strategy in HL Pharma it is an end-to-end process that integrates and defines the intersecting points between design content/change control and drug registration development Change Category: Additional Information for Document User: Major Training: Required N/A Document Owner: Revision DCR/CP Number Administrative Issue Date Not Required APPROVALS Approver: Processor: HISTORY Local Change Request Number N/A Reason for Change N/A N/A N/A CONFIDENTIAL - INTERNAL USE ONLY REV Doc code : PTKD_02 Ver.: 01 Product development procedure HOANG LONG  Review and approval Prepared by Reviewed by Approved by I PURPOSE Eff date: 1.1.2010 Page : 1/4 Doc code : PTKD_02 Ver.: 01 Product development procedure Page HOANG LONG   Eff date: 1.1.2010 : 2/4 To regulate new/renewal registrations in HL Pharma II SCOPE:  From starting registration preparation or from months prior the expiry date of the current drug license until new/renewal visa granted III RESPOSIBILITIES  Head of R&D  Logistic department   IV CONTENT FLOWCHART DESCRIPTION - Receive registration plan/request WHO R&D Head R&D DOCUMENT staff/ N/A of REGISTRATION NEEDED PREREGISTRATION - Liase with Manufacturer to get registration dossier R&D staff/ - Classify type of registrations - Collecting references and supporting Manufacturer documents RA Pharmaceutical Laws Drug registration regulation (circular 22/2009/TTBYT) Doc code : PTKD_02 Ver.: 01 Product development procedure Eff date: 1.1.2010 Page HOANG LONG  Not approve PLANNING APPROVAL Approved : 3/4 - Planning for registration (submission due within weeks from date of receiving sufficient supporting registration dossier) o Date of submission/approval o Budget o Co-ordinate with related Departments/Manufacturer to distribute registration plan - Head of R&D to review registration plan - Head of Finance Department to review budget - CEO to approve final registration plan ACTD guideline INITIATION - Registration submission - Archiving and record   SUBMISISON - Dossier submission - Follow up and supplement upon request - Monthly update to Head of R&D Not pass R&D staffs Claim form for Registration fee R&D staffs Pass REVIEW Review and update registration plan (if Head of applicable) report to CEO in case of additional fee R&D required UPDATE Not pass Pass CEO: review and approve again CEO Doc code : PTKD_02 Ver.: 01 Product development procedure HOANG LONG  Eff date: 1.1.2010 Page : 4/4 - Review and request for amendments if required  R&D staff Product information review form PROMOTION Materials - Preparation for promotional materials - Request Importer Department to prepre for R&D staff Price declaration Relevant DAV guidelines Handover approved materials - To provide approval certificates (copy) to R&D staff Marketing department, tender department - Record and archiving (License, registration dossiers) - Final report to Head of R&D, CEO REVIEW approval document A B C D E F Warehouse GDP Compliant Checklist Name of Warehouse Organization: HL Pharma Warehouse x - Full Compliance x - Partial Compliance Date of Audit / Assessment Completion: 28-Aug-15 x QMS - Control of Documents/Records 10 11 x 1.1 Is there a documented procedure for the control of documents? 12 x 1.2 Are documents prepared, approved, signed and dated by an appropriate authorized person? 1.3 Documents must be reviewed regularly and kept up-to-date Are obsolete documents withdrawn from places where they 13 x are used? 14 x 1.4 Is a list of controlled documents maintained? 15 x 1.5 Are records maintained to provide evidence of conformity to requirements of GDP as applicable? 1.6 Is there a documented procedure to define the controls needed for identification, storage, protection, retrieval, retention time and disposition of records? 16 x 17 x 1.7 Are there written procedures in place defining processes to meet Supply Chain Security requirements? 18 Personnel Training, Responsibility and Authority 19 2.1 Are personnel appropriately trained to possess necessary competence to performing the work? 20 x 21 x 2.2 Are training records maintained? 22 x 2.3 Are interrelation between personnel who manage, perform and verify work that affects quality clearly established? 2.4 As allowed by law, are background, employment history, and references being checked on prospective employees and periodically checked for current employees? 23 x 24 Premises and Facilities (Cleanliness, Pest Control, Lighting and Access Control) 25 26 3a Cleanliness 3.1 Is the premise/equipment suitable and adequate to ensure proper conservation and distribution of products? 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 3.2 Is there documentation that spells out requirements for cleaning of premises including frequency and methods? 3.3 Are cleaning records maintained? 3b Pest Control 3.4 Is there a pest control programme to identify and prevent pest infestation? 3.5 Are records of pest control programme maintained? 3.6 Are approved chemicals documented and being used appropriately in the pest control program? 3c Temperature & Humidity Monitoring 3.7 Are temperature and relative humidity monitored and recorded periodically where appropriate? Comments No changes from 2010 Email communication Personnel are trained but no any training record x Most of HL Pharma imported products are required to be stored from 4-8'C or below 25'C However, no temperature data have been regularly recorded per process, no any corrective action, re-validated reports were documented x Temperature and humidity are recorded but there is no validation or corrective action in case of out-of-specification data as explained in3.1 x x x x x 3d Lighting 3.8 Is there enough light so that personnel can read product labeling and perform work activities? Inclusive of container x loading dock doors for inspection 3e Fire prevention x 3.9 Is there sufficient and suitable fire prevention? 3f Access Control Are access controls being used appropriately to prevent unauthorized entry to facilities? Access controls must include the 3.10 positive identification and control of all employees, visitors, and vendors at all points of entry x 3.11 Have personnel with access to restricted areas been defined? 3.12 Are there physical barriers and deterrents(fencing, gates, lights, alarm systems and/or video surveillance cameras) that help guard against unauthorized access? 3.13 Do automated systems require password access? - Non - Compliance x x x Storage and Stock Handling - (Receiving, Storage and Delivery) 4a Storage 4.1 Is there a separate area, to allow segregation of quality hold, product returns, expired, or other non-conforming products from useable inventory? 48 There are shelves for returned products, expired product and non-conforming products but not enough space for huge quantity of products Logistic manager explained that there were no issue with Biotest products in the past and products are usually out of stock before expiration x 4.2 Is the area assigned to store defective products with restricted access? 49 50 51 52 53 54 55 56 57 58 4.3 Are hazardous/dangerous products or materials properly stored and associated hazardous documents available? 4.4 Is there objective evidence to indicate that the Damage Standard is understood and used by all personnel who handle product? 4.5 Is the inventory cycle counting process being followed according to procedures? 4.6 Are products beyond their expiry date separated from useable stock and not sold or supplied? 4.7 Are non-conforming products clearly identified as such and segregated, if not immediately destroyed? 4.8 Is the FEFO principle followed and in case of exception is there a written rationale? 4.9 Is product scrap performed legally, adequately, and in an environment friendly way? x x There is shelves for ONHOLD storage, but not "restrict access" Warehouse Manager explained that two reasons for this are limited space and not many defective products x x x x x No record related to destroyed product before x 4b Receiving 4.10 Are receiving areas separate from storage areas? x Movable panels are used due to limited space A B C D E F 59 60 61 62 Warehouse GDP Compliant Checklist 4.11 Are there inspections or other activities to ensure that products received meet specified requirements? 4.12 Are records of verifications or incoming inspections being maintained? 4.13 Are receiving discrepancies reported to the appropriate individuals? 4c Delivery 4.14 Are transportation methods adequate to achieve safe and secure delivery of all medical devices and disposables from collection to delivery points? x x x 63 64 65 66 67 68 69 70 x 4.15 Are products transported such that identification is not lost, contamination, spillage, theft, breakage and exposure to extreme climatic conditions are prevented? 4.16 Do container seals meet or exceed the current PAS ISO 17712 standards for high security seals, and are they being affixed to all loaded outbound containers and trailers? 4.17 Are the seals kept in a locked area? Is a log kept for seal disbursment? x 4.18 Are seal numbers verfied against origin documentation on Int'l inbound containers? 4.19 Is the physical integrity of containers and trailers being check by inspecting the following points: Front wall, left side, right side, floor, ceiling/roof, inside/outside doors, outside/undercarriage? Includes inbound and outbound containers and trailers x 4.20 Are containers stored in a secure area to prevent unauthorized access and/or manipulation? 4.21 If the 3PL is providing transportation services, are they utilizing a tracking and monitoring activity log or equivalent technology to ensure conveyance integrity is maintained while the conveyance is en route? x Goods are delivered by HL Pharma car Goods to provinces will be gathered and also delivered twice per month by car Temperature devices are checked and data recorded but not for all shipments No changes in procedure since 2010 Not applicable as HL Pharma not ship goods in container Not applicable as HL Pharma not ship goods in container No record or procedure No record or procedure Not applicable as HL Pharma not ship goods in container No record or procedure A B C D E F 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 Warehouse GDP Compliant Checklist Traceability and Recording 5.1 Are records maintained for each receipt stating quantity, item number, supplier, date of receipt and the lot or serial number where applicable? 5.2 Are records of customer delivery, date, address, customer name, serial numbers being maintained? 5.3 Are records of returns kept? 5.4 Are records maintained to trace the history of products under quarantine assessments and movements? x x x Field Corrective Action x x x 6.1 Is there a documented procedure for handling Field Corrective Action (FCA)? 6.2 Is it clearly defining the responsibilities for planning, conducting, reporting of corrective actions? 6.3 Are records of FCA being maintained? Internal Audits 7.1 Has the warehouse been inspected by a regulatory agency/organization regarding GDP in the past years 7.2 Is the warehouse operator licensed by a regulatory agency for GDP? 7.3 Is there an internal audit plan to monitor the implementation of and compliance with the requirements of GDPMDS? x Since 2010, 2013, valid for years x 86 87 88 89 90 91 92 93 94 No return happened before No record so far x 7.4 Is there a documented procedure that describes the responsibilities/requirements for planning and conducting audits, reporting of results and maintenance of audit records? 7.5 Are there records of detected nonconformities and their causes? 7.6 Are there records and report of actions and verifications results of these actions? 7.7 Has the facility been inspected by a local fire authority in the past years? 7.8 Where there any negative findings in the fire inspection? If so, were they resolved successfully? x x x x x Complaints Management (to be evaluated if applicable, or if Manufacturer' manages this part) 8.1 Is there a documented procedure for complaints management? 8.2 95 x Are all complaints collected, recorded and properly investigated? x Is the complainant informed on the result of the investigation? x Performed by Marketing department No procedure and no record Performed by Marketing department No procedure and no record Are the proper corrective/preventive actions taken as a result of the complaints root cause identification? x Performed by Marketing department No procedure and no record 8.3 96 8.4 97 98 99 100 101 102 Assessment completed by: Nguyen Nhu Trang- 28-29 Aug 2015 [...]... sites and processes with Good Manufacturing Practice (GMP) standards 14 • Assessment and inspection of all components of the pharmaceutical supply chain • Maintenance of a register of available products, and post-marketing surveillance activities, including random sampling of registered medicines for quality control and pharmacovigilance • Promotion, advertising and provision of medicines information All... scientific data and information on the product They manage the communication and negotiations with the authorities They are accountable for maintenance of marketing authorizations and are involved in the life-cycle management of a product In addition to handling regulatory submission, Regulatory Affairs leads labeling compliance, and DAV listings and registrations, and acts as the official DAV correspondent... preliminary information of that medicine, applicant and its manufacturer The quality part contains detailed information of the active pharmaceutical ingredient(s) (APIs) used and finished pharmaceutical product whereas in ensuring medicines safety and efficacy, these data are provided in the clinical part of the dossier 3 Quality has been recognized broadly as one of the key factors to success in the... delay in registration has created more customer complaints and unavailability of medicines within the medicines supply chain 1.5 GENERAL DESCRIPTION OF REGISTRATION PROCESSES 1.5.1 Drug regulation process A drug registration process generally covers the following areas: • Pre-marketing assessment and evaluation of the quality, safety and efficacy of a medicine, including compliance of manufacturing... The first purpose of this study was to determine challenges faced by both DAV and local pharmaceutical companies in biological drug registration In Vietnam, medicine registration is an official authorization or registration of a product by DAV for the purpose of marketing or free distribution in the country after evaluation for safety, efficacy and quality (Drug Administration of Vietnam, 2015) Hence,... quality of registration dossier Lack of updated reference materials during evaluation was also 28 mentioned as one of the challenges in drug registration process (DAV registration process – Annex 2) Chapter 2: ASSESSMENT OF CHALLENGES IN DRUG REGISTRATION PROCESS AND REVIEW Challenges that hinder smooth drug registration process were investigated in two ways; first to the evaluators who are dealing... the establishment of the Global Cooperation Group As well as making information available, the group will act as a resource in the understanding, and even acceptance, of many of the guidelines Drug Registration harmonization provide benefit for better health: • Regulatory harmonization offers many benefits to both regulatory authorities and the pharmaceutical industry, and has a positive impact for the... in excess of what is necessary may become a technical barrier to trade In applying technical regulations, DAV has adopted an approach of using international standards and practices and alignment with the WTO/TBT obligations, where possible Furthermore, DAV need to provide a Regulatory Practice Guide for regulators and Applicants to assist in the preparation and adoption of efficient regulatory arrangements... objective of evaluation is to ensure that before a medicine is placed on the market there is enough evidence that it has been properly formulated, manufactured and adequately tested and meets the criteria of safety, efficacy and quality A drug product registration dossier is a set of document that consists of data on administrative, pharmaceutical, clinical and labeling of the product The administrative part... Dugs (Pharmaceutical finished products) are only authorized to circulate in the market after being registered The Drug administration of Vietnam (DAV) has been mandated by the Vietnam Ministry of Health to ensure quality, safety and efficacy of medicines Since about 70% of medicines are imported from abroad, registration process contributes to the availability of quality, safe and efficacious medicinal