GMP Documents for Pharmaceutical Manufacturers

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This document is intended to provide guidance regarding Good Manufacturing Practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. Global Manager Group provide demo of GMP documents kit which are primary documentation requirements.

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D139: DEMO OF GMP ICH Q7 DOCUMENT KIT Price 599 USD Applicable for Pharmaceuticals manufacturer based on Active Pharmaceutical ingredients API Complete editable Good Manufacturing Practices GMP Q7 document kit Manual procedures process approach exhibits SOPs formats audit checklist etc. Buy: www.globalmanagergroup.com To get more information about GMP Q7 Documentation kit Click Here www.globalmanagergroup.com E mail salesglobalmanagergroup.com Page 1 of 9 The Total Editable Document kit has 7 main directories as below. GMP- ICH Q7 Editable Document kit for API manufacturer Sr. No. List of Directory Document of Details 1. GMP Manual 15 chapter and 05 annexurein MS Word 2. Procedures 08procedures in MS Word 3. Process approach 10 process approach in MS Word 4. Standard operating procedures 74standard operating procedure in MS Word Personnel and administration PA 17 Standard operating procedure in MS Word Quality Assurance QA 52 Standard operating procedure in MS Word System SYS 05 Standard operating procedure in MS Word 5. Exhibits 06 Exhibits in MS Word 6. Formats 53 formats in MS Word Engineering ENG 03 formats in MS Word Purchase PUR 05 formats in MS Word Despatch DES 05 formats in MS Word Housekeeping HKC 04 formats in MS Word Marketing MKT 03 formats in MS Word Production PRD 05 formats in MS Word Quality control QCD 06 formats in MS Word Stores STR 05 formats in MS Word System SYS 11 formats in MS Word Training TRG 06 formats in MS Word 7. Audit checklist More than 800 questions Total 165 files quick download in editable form by e delivery Chapter-1.0 CONTENTS OF GMP ICH Q7 DOCUMENT KIT Good Manufacturing Practices for Pharmaceutical companies based on API More than 165 document files

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D139: DEMO OF GMP ICH Q7 DOCUMENT KIT Price 599 USD Applicable for Pharmaceuticals manufacturer based on Active Pharmaceutical ingredients API Complete editable Good Manufacturing Practices GMP Q7 document kit Manual procedures process approach exhibits SOPs formats audit checklist etc. Buy: www.globalmanagergroup.com To get more information about GMP Q7 Documentation kit Click Here www.globalmanagergroup.com E mail salesglobalmanagergroup.com Page 2 of 9 B. Documentation:- Our document kit is having sample documents required for GMP Q7certification as listed below. You need to study it do necessary changes as per your company need and within 4 days your entire editable documents with all necessary details are ready as well as your team will got many ideas for system establishment to reduce the cost and effort with all necessary controls and your total documents are ready. We had given all type of templates and organization use it as per their need and many organization are certified globally in 1 st trial with the help of our documents from any kind of stringent lead appraisal audit. Under this directory further files are made in word document as per the details listed below. All the documents are related to GMP Q7 for and user can edit it in line with their own processes. 1. GMP Manual: It covers sample copy of manual for GMPQ7 ICH Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. It covers 15 chapter and 05 annexure as well as list of procedures as well as overview of covers tier1 of GMP Q7 documents. GMP Q7 Manual Index Chapter No. Subject Page No. 1 Company Profile 1 – 5 Introduction Table of Contents 2.1 Principles 1 – 3 2.2 Responsibilities of the Quality Unit 2.3 Responsibility for production activities 2.4 Internal audits 2.5 Product quality review 3.1 Personnel Qualifications 1 – 1 3.2 Personnel Hygiene 3.3 Consultants 4.1 Design and Construction 1 – 2 4.2 Utilities 4.3 Water 4.4 Containment 4.5 Lighting 4.6 Sewage and Refuse 4.7 Sanitation and Maintenance 5.1 Design and Construction 1 – 2 5.2 Equipment Maintenance and Cleaning 5.3 Calibration 5.4 Computerized Systems 6.1 Documentation System and Specifications 1 – 4

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D139: DEMO OF GMP ICH Q7 DOCUMENT KIT Price 599 USD Applicable for Pharmaceuticals manufacturer based on Active Pharmaceutical ingredients API Complete editable Good Manufacturing Practices GMP Q7 document kit Manual procedures process approach exhibits SOPs formats audit checklist etc. Buy: www.globalmanagergroup.com To get more information about GMP Q7 Documentation kit Click Here www.globalmanagergroup.com E mail salesglobalmanagergroup.com Page 3 of 9 6.2 Equipment Cleaning and Use Record 6.3 Records of Raw Materials Intermediates API Labelling and Packaging Materials 6.4 Master Production Instructions Master Production and Control Records 6.5 Batch Production Records Batch Production and Control Records 6.6 Laboratory Control Records 6.7 Batch Production Record Review 7.1 General Controls 1 – 2 7.2 Receipt and Quarantine 7.3 Sampling and Testing of Incoming Production Materials 7.4 Storage 7.5 Re-evaluation 8.1 Production Operations 1 – 2 8.2 Time Limits 8.3 In-process Sampling and Controls 8.4 Blending Batches of Intermediates or APIs 8.5 Contamination Control 9.1 General 1 – 2 9.2 Packaging Materials 9.3 Label Issuance and Control 9.4 Packaging and Labeling Operations 10.1 Warehousing Procedures 1 – 1 10.2 Distribution Procedures 11.1 General Controls 1 – 2 11.2 Testing of Intermediates and APIs 11.3 Validation of Analytical Procedures 11.4 Certificates of Analysis 11.5 Stability Monitoring of APIs 11.6 Expiry and Retest Dating 11.7 Reserve/Retention Samples 12.1 Validation Policy 1 – 2 12.2 Validation Documentation 12.3 Qualification 12.4 Approaches to Process Validation 12.5 Process Validation Program 12.6 Periodic Review of Validated Systems 12.7 Cleaning Validation 12.8 Validation of Analytical Methods 13.0 Change control 1 – 1 14.1 Rejection 1 – 2 14.2 Reprocessing

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D139: DEMO OF GMP ICH Q7 DOCUMENT KIT Price 599 USD Applicable for Pharmaceuticals manufacturer based on Active Pharmaceutical ingredients API Complete editable Good Manufacturing Practices GMP Q7 document kit Manual procedures process approach exhibits SOPs formats audit checklist etc. Buy: www.globalmanagergroup.com To get more information about GMP Q7 Documentation kit Click Here www.globalmanagergroup.com E mail salesglobalmanagergroup.com Page 4 of 9 14.3 Reworking 14.4 Recovery of Materials and Solvents 14.5 Returns 15.0 Complaints and recalls 1 – 1 Annexure ANX-I List of GMP Procedures 1 – 1 ANX-II Glossary of Terms 1 – 1 ANX-III Process Flow Chart 1 – 2 ANX-IV Organization structure 1 – 1 ANX–V. Quality Policy 1 – 1 2. Procedures 08 Procedures: It covers sample copy of mandatory procedures covering all the details of Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. List of procedure 1. Procedure for management review 2. Procedure for document and data control 3. Procedure for Control of Records 4. Procedure for internal audit 5. Procedure for Training 6. Procedure for corrective and preventive action 7. Procedure for Control of Monitoring and Measuring equipments 8. Procedure for Control of Non–Conforming Products 3. Process approach 10process approach: It covers sample copy of process approach covering all the details of Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. List of process approach 1. Process Flow Chart of Customer Service 2. Process Flow Chart of Dispatch 3. Process Flow Chart of Engineering 4. Process Flow Chart of Marketing 5. Process Flow Chart of Production 6. Process Flow Chart of Purchase 7. Process Flow Chart of Quality Control 8. Process Flow Chart of System Coordinator processes 9. Process Flow Chart of Stores 10. Process Flow for Training Activity

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D139: DEMO OF GMP ICH Q7 DOCUMENT KIT Price 599 USD Applicable for Pharmaceuticals manufacturer based on Active Pharmaceutical ingredients API Complete editable Good Manufacturing Practices GMP Q7 document kit Manual procedures process approach exhibits SOPs formats audit checklist etc. Buy: www.globalmanagergroup.com To get more information about GMP Q7 Documentation kit Click Here www.globalmanagergroup.com E mail salesglobalmanagergroup.com Page 5 of 9 4. Standard operating procedures 74SOPs: It covers sample copy of standard operating procedures covering all the details of Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. List of standard operating procedures SOPs 1. SOP for personnel and administration 2. SOP for medical checkup of employees 3. SOP for personnel hygiene 4. SOP for cleaning sanitization of factory premises 5. SOP for garbage disposal 6. SOP for maintenance of building 7. SOP for scrap disposal 8. SOP for security system 9. SOP for safety training 10. SOP for first aid training 11. SOP for induction training 12. SOP for pest control 13. SOP for entry and exit for visitors 14. SOP for cleaning procedure for uniforms 15. SOP for dress code 16. SOP for record of specimen signature 17. SOP for job responsibility 18. SOP for SOP 19. SOP for Control of Version Archival and Retrieval of Data 20. SOP for Receipt and Handling of Market Complaints 21. SOP for Product recall 22. SOP for Handling of market returns 23. SOP for Change control system 24. SOP for Deviation and Investigation 25. SOP for Quality audit 26. SOP for Internal audit self inspection 27. SOP for Non-conformance Procedure 28. SOP for Non-conformance of Materials 29. SOP for Vendor quality audit 30. SOP for Purchasing quality materials from approved vendors 31. SOP for Calibration and Preventive Maintenance of Equipment/Instrument 32. SOP for Out of Calibration OOC 33. SOP for Out of specification OOS 34. SOP for Generation and Movement of Artwork 35. SOP for Rework procedure 36. SOP for Numbering and Codification System For Master Documents 37. SOP for Sampling procedure for finished product analysis 38. SOP for Entry Procedure for Sampling Area 39. SOP for In-process Inspection During Manufacturing 40. SOP for Cleaning of sampling equipments 41. SOP for Disposition of rejected materials 42. SOP for Destruction procedure for samples 43. SOP for Handling and storage of raw material control samples 44. SOP for Shelf life of finished product formulations 45. SOP for Annual review of finish products 46. SOP for Printed product label control 47. SOP for Printed product carton control 48. SOP for Line clearance 49. SOP for Disposition of components and products 50. SOP for Batch reconciliation 51. SOP for Handling and storage of controlled samples 52. SOP for Retain samples and its disposal 53. SOP for Preparation of Master Batch Manufacturing Record 54. SOP for Stability study 55. SOP for Corrective and Preventive Action 56. SOP for Mock recall 57. SOP for Training system 58. SOP for Batch release of Finished Products 59. SOP for Equipment Status Labeling and Equipment Logbook Entry 60. SOP for Failure investigation 61. SOP for Introduction to validation 62. SOP for Fundamentals of validation sop 63. SOP for Guidelines for DQ IQ OQ PQ 64. SOP for Design qualification guideline for minimizing the risk of product cross-contamination by air handling unit 65. SOP for Validation glossary 66. SOP for Revalidation 67. SOP for Guidelines for area validation: clean area 68. SOP for Validation of HVAC system 69. SOP for Analyst validation 70. SOP for Prevention of Cross Contamination 71. SOP for Housekeeping Cleaning 72. SOP for Building Maintenance and General Facilities 73. SOP for Cleaning of Doors Windows Walls and Tube light and Fan 74. SOP for Personal Hygiene

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D139: DEMO OF GMP ICH Q7 DOCUMENT KIT Price 599 USD Applicable for Pharmaceuticals manufacturer based on Active Pharmaceutical ingredients API Complete editable Good Manufacturing Practices GMP Q7 document kit Manual procedures process approach exhibits SOPs formats audit checklist etc. Buy: www.globalmanagergroup.com To get more information about GMP Q7 Documentation kit Click Here www.globalmanagergroup.com E mail salesglobalmanagergroup.com Page 6 of 9 5. Exhibits 06exhibits: It covers sample copy of exhibits covering all the details of Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. List of exhibits 1. Skill requirements 2. Multi Skill requirements 3. Control of non–conforming products 4. Document codification system 5. Quality Plan 6. Raw material specification 6. Blank Formats 53 Formats: It covers sample copy of blank forms required to maintain records as well as establish control and make system. The samples given are as a guide and not compulsory to follow to change the same to suit own requirements. List of Formats 1. Master List Distribution List of Documents 2. Change Note 3. Corrective Action Report 4. Master List of Records 5. Quality Objectives Monitoring Sheet 6. Audit Plan / Schedule 7. SYS Internal Quality Audit Non–Conformity Report 8. GMP Clause wise Audit Review Report 9. Quality Objective Plan 10. Calibration Status of Instrument / Equipment 11. List of License / certificates 12. Training Calendar 13. Employee Wise Training Competence Record Sheet 14. Induction Training Report 15. Job Description Specification 16. Training Report 17. Skill Matrix 18. Purchase Order 19. Indent And Incoming Inspection Record 20. Approved external provider list Annual purchase order 21. External Provider Registration Form 22. Annual Purchase Order 23. Order Form / Order Confirmation 24. Customer Complaint Report 25. Customer Feed Back Form 26. Breakdown History Card 27. Preventive Maintenance Schedule 28. Preventive Maintenance Check Points 29. Gate pass 30. Material Issue Slip 31. Preservation Assessment Report 32. Goods Receipt Note 33. Unloading Vehicle Checking Report 34. Production Plan 35. Disposal of Non-Conforming Products 36. Blending Data Sheet 37. Tray Dryer Log Sheet 38. Spin Flash Dryer Log Sheet 39. Sample Test Request Slip For Incoming materials 40. Sample Test Request Slip For In process / Finish product 41. Normality Record Sheet 42. pH Meter Calibration Report 43. Stability Study Report 44. Equipment Cleaning Validation Report 45. Packing Report / Slip 46. Bag / Other Packing Material Inspection Report 47. Screen Checking Report 48. Label issue register 49. Loading Vehicle Checking Report 50. Cleaning and Sanitation Report 51. Visitor’s Entry Report 52. Sanitation Audit Report 53. Equipment Cleaning Report 7. Audit checklist more than 800 questions It covers sample audit questions based on all the GMP Q7 good manufacturing practice guidance requirements based on GMP ICH standard. It helps the auditor to make own audit checklist for quick and perfect auditing to ensure all the Q7 good manufacturing practice guidance requirements are fulfilled.

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D139: DEMO OF GMP ICH Q7 DOCUMENT KIT Price 599 USD Applicable for Pharmaceuticals manufacturer based on Active Pharmaceutical ingredients API Complete editable Good Manufacturing Practices GMP Q7 document kit Manual procedures process approach exhibits SOPs formats audit checklist etc. Buy: www.globalmanagergroup.com To get more information about GMP Q7 Documentation kit Click Here www.globalmanagergroup.com E mail salesglobalmanagergroup.com Page 7 of 9 Global Manager Group is a progressive company and promoted by a group of qualified engineers and management graduates having rich experience of 25 years in ISO consultancy and management areas. The company serves the global customers through on-site and off-site modes of service delivery systems. We offer a full range of consulting services geared towards helping all types of industries and laboratories to achieve competitiveness certifications and compliance to international standards and regulations. So far we had more than 1800 clients in more than 45 countries. Our readymade training and editable document kit helps the client in making their documents easy and make them complying to related ISO standard faster. 1. Our promoters and engineers have experience of more than 1800 companies globally for management training ISO series consultancy. We had clients in more than 45 countries. 2. Highly qualified 50 team members M.B.A. Degree engineers and owner is having rich professional experience since 1991. 3. We have 100 success rate for ISO series certification of our clients from reputed certifying body and branded image and leading name in the market. 4. Suggest continual improvement and cost reduction measures as well as highly informative training presentations and other products gives payback within 2 months against our cost. 5. So far more than 50000 employees are trained by us in ISO series certification. 6. We had spent more than 60000 man-days 170 man years in preparing ISO documents and training slides. Global Manager Group is committed for: 1. Personal involvement commitment from first day 2. Optimum charges 3. Professional approach 4. Hard work and update the knowledge of team members 5. Strengthening clients by system establishment and providing best training materials in any areas of management to make their house in proper manner 6. To establish strong internal control with the help of system and use of the latest management techniques. Chapter - 2.0 ABOUT COMPANY

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D139: DEMO OF GMP ICH Q7 DOCUMENT KIT Price 599 USD Applicable for Pharmaceuticals manufacturer based on Active Pharmaceutical ingredients API Complete editable Good Manufacturing Practices GMP Q7 document kit Manual procedures process approach exhibits SOPs formats audit checklist etc. Buy: www.globalmanagergroup.com To get more information about GMP Q7 Documentation kit Click Here www.globalmanagergroup.com E mail salesglobalmanagergroup.com Page 8 of 9 3.1 Hardware and Software Requirements A. Hardware:-  Our document kit can be better performed with the help of P3 and above computers with a minimum 10 GB hard disk space.  For better visual impact of the power point Document you may keep the setting of colour image at high colour. B. Software used in Document kit  Documents written in Ms Office 2003 and window XP programs. You are therefore required to have office 2003 or above with window XP 3.2 Features of Document kit:-  Contains all necessary documents as listed above and comply with the requirements of GMP Q7 Standards.  Written in Plain English  It will save much time in typing and preparation of documents alone.  User-friendly and easy to learn.  Developed under the guidance of experienced experts.  Provides model of a Management system that is simple and free from excessive paperwork. Chapter - 3.0 USER FUNCTION

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D139: DEMO OF GMP ICH Q7 DOCUMENT KIT Price 599 USD Applicable for Pharmaceuticals manufacturer based on Active Pharmaceutical ingredients API Complete editable Good Manufacturing Practices GMP Q7 document kit Manual procedures process approach exhibits SOPs formats audit checklist etc. Buy: www.globalmanagergroup.com To get more information about GMP Q7 Documentation kit Click Here www.globalmanagergroup.com E mail salesglobalmanagergroup.com Page 9 of 9 1. By using these documents you can save a lot of your precious time while preparing the GMP Q7documents. 2. Take care for all the section and sub sections of GMP-ICH Q7 standard helps you in establishing better system applicable for manufacturer of Active pharmaceutical ingredients API. 3. Document kit enables you to change the contents and print as many copies as you need. The user can modify the documents as per their industry and create own GMP Q7 documents. 4. Save much time and cost in document preparation. 5. You will get better control in your system due to our proven formats. We had helped to more than 20 companies globally to get GMP certificate from reputed certifying agency 6. You will get better control in your system due to our proven documents and templates developed under the guidance of our experts and globally proven consultants having rich experience of more than 25 years in ISO consultancy. 7. Our products are highly sold globally and used by many multinational companies and had provided total customer satisfaction as well as value for money. 8. In preparation of document kits it is been verified and evaluated at various levels of our team and more than 1000 hours are spent in preparation of this product kit. 9. Prepared by globally proven team of leading consultant. On secured completion of purchase we provide user name and password to download the product from our ftp server. Thus we are providing instant on line delivery of our products to user by sending e mail of user name and password. For purchase Click Here BUY Visit our web site for more documentation kit: http://www.globalmanagergroup.com/E-Shop.aspx Chapter - 4.0 BENEFITS OF USING OUR DOCUMENT KIT Chapter-5.0 METHOD OF ONLINE DELIVERY

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