GMP ICH Q7 Documentation Kit for Pharmaceutical Manufacturers

We have developed the GMP Q7 Documentation to guide pharmaceutical manufacturers for Good Manufacturing Practices – GMP certification, in accordance with ICH Q7 requirements, for API (Active Pharmaceutical Ingredients) manufacturers in the pharmaceutical industry.

Documentation:-

Our document kit is having sample documents required for GMP Q7 certification 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 organizations are certified globally in
1st 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 20 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
1.0 Company Profile
Introduction
Table of Contents
2.0 Quality management
2.1 Principles
2.2 Responsibilities of the Quality Unit
2.3 Responsibility for production activities
2.4 Internal audits
2.5 Product quality review
3.0 Personnel
3.1 Personnel Qualifications
3.2 Personnel Hygiene
3.3 Consultants
4.0 Building and Facilities
4.1 Design and Construction
4.2 Utilities
4.3 Water
4.4 Containment
4.5 Lighting
4.6 Sewage and Refuse
4.7 Sanitation and Maintenance
5.0 Process Equipment
5.1 Design and Construction
5.2 Equipment Maintenance and Cleaning
5.3 Calibration
5.4 Computerized Systems
6.0 Documentation & Records
6.1 Documentation System and Specifications
6.2 Equipment Cleaning and Use Record
6.3 Records of Raw Materials, Intermediates, API Labeling 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
7.0 Materials Management
7.1 General Controls
7.2 Receipt and Quarantine
7.3 Sampling and Testing of Incoming Production Materials
7.4 Storage
7.5 Re-evaluation
8.0 Production & in-process control
8.1 Production Operations
8.2 Time Limits
8.3 In-process Sampling and Controls
8.4 Blending Batches of Intermediates or APIs
8.5 Contamination Control
9.0 Packaging and identification labeling of APIs and intermediates
9.1 General
9.2 Packaging Materials
9.3 Label Issuance and Control
9.4 Packaging and Labeling Operations
10.0 Storage and Distribution
10.1 Warehousing Procedures
10.2 Distribution Procedures
11.0 Laboratory Controls
11.1 General Controls
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
12.0 Validation
12.1 Validation Policy
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
14.0 Rejection and Re-use of materials
14.1 Rejection
14.2 Reprocessing
14.3 Reworking
14.4 Recovery of Materials and Solvents
14.5 Returns
15.0 Complaints and recalls
16.0 Contract manufacturers (Including Laboratories)
17.0 Agents, Brokers, Traders, Distributors, Repackers and Relabellers
17.1 Applicability
17.2 Traceability of Distributed APIs and Intermediates
17.3 Quality Management
17.4 Repackaging, Relabeling and Holding of APIs and Intermediates
17.5 Stability
17.6 Transfer of Information
17.7 Handling of Complaints and Recalls
17.8 Handling of Returns
18.0 Specific guidance for APIs manufactured by cell culture / fermentation
18.1 General
18.2 Cell Bank Maintenance and Record Keeping
18.3 Cell Culture/Fermentation
18.4 Harvesting, Isolation and Purification
18.5 Viral Removal/Inactivation steps
19.0 APIs for use in clinical trials
19.1 General
19.2 Quality
19.3 Equipment and Facilities
19.4 Control of Raw Materials
19.5 Production
19.6 Validation
19.7 Changes
19.8 Laboratory Controls
19.9 Documentation
20.0 Glossary
Annexure
ANX-I List of GMP Procedures
ANX-II Glossary of Terms
ANX-III Process Flow Chart
ANX-IV Organization structure
ANX–V Quality Policy

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 (10 process 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
11. 4. Standard operating procedures (74 SOPs):

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 personnel hygiene
3. SOP for garbage disposal
4. SOP for scrap disposal
5. SOP for safety training
6. SOP for induction training
7. SOP for maintenance of building
8. SOP for medical checkup of employees
9. SOP for first aid training
10. SOP for security system
11. SOP for cleaning & sanitization of factory premises
12. SOP for entry and exit for visitors
13. SOP for dress code
14. SOP for job responsibility
15. SOP for Control of Version, Archival and Retrieval of Data
16. SOP for Product recall
17. SOP for Receipt and Handling of Market Complaints
18. SOP for pest control
19. SOP for cleaning procedure for uniforms
20. SOP for record of specimen signature
21. SOP for SOP
22. SOP for Change control system
23. SOP for Quality audit
24. SOP for Non-conformance Procedure
25. SOP for Vendor quality audit
26. SOP for Calibration and Preventive Maintenance of Equipment/Instrument
27. SOP for Out of specification (OOS)
28. SOP for Rework procedure
29. SOP for Sampling procedure for finished product analysis
30. SOP for In-process Inspection During Manufacturing
31. SOP for Disposition of rejected materials
32. SOP for Handling and storage of raw material control samples
33. SOP for Handling of market returns
34. SOP for Deviation and Investigation
35. SOP for Internal audit (self inspection)
36. SOP for Purchasing quality materials from approved vendors
37. SOP for Non-conformance of Materials
38. SOP for Out of Calibration (OOC)
39. SOP for Generation and Movement of Artwork
40. SOP for Numbering and Codification System For Master Documents
41. SOP for Entry Procedure for Sampling Area
42. SOP for Annual review of finish products
43. SOP for Cleaning of sampling equipments
44. SOP for Destruction procedure for samples
45. SOP for Printed product carton control
46. SOP for Disposition of components and products
47. SOP for Handling and storage of controlled samples
48. SOP for Preparation of Master Batch Manufacturing Record
49. SOP for Corrective and Preventive Action
50. SOP for Training system
51. SOP for Equipment Status Labeling and Equipment Logbook Entry
52. SOP for Introduction to validation
53. SOP for Guidelines for DQ, IQ, OQ & PQ
54. SOP for Shelf life of finished product formulations
55. SOP for Printed product label control
56. SOP for Line clearance
57. SOP for Batch reconciliation
58. SOP for Retain samples and its disposal
59. SOP for Failure investigation
60. SOP for Stability study
61. SOP for Mock recall
62. SOP for Fundamentals of validation sop
63. SOP for Batch release of Finished Products
64. SOP for Validation glossary
65. SOP for Guidelines for area validation: clean area
66. SOP for Analyst validation
67. SOP for Housekeeping & Cleaning
68. SOP for Cleaning of Doors, Windows, Walls and Tube light and Fan
69. SOP for Personal Hygiene
70. SOP for Design qualification guideline for minimizing the risk of product cross contamination by air handling unit
71. SOP for Prevention of Cross Contamination
72. SOP for Revalidation
73. SOP for Validation of HVAC system
74. SOP for Building Maintenance and General Facilities

5. Exhibits (06 exhibits):

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 (64 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
14. Induction Training Report Record Sheet
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
54. Laboratory Investigation Report For Out Of Specification
55. Line Clearance Label
56. Record For Rework
57. Out of Calibration Label
58. Vendor Audit Report
59. Recall Format
60. Stability Protocol and Report
61. Mock Recall Form
62. Destruction Approval Form
63. Out of Specification Log
64. Deviation Report Form

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 Q7 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.

8. GMP ICH Q7 compliance matrix

The Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients based on ICH guidance requirement wise list of documented information reference of this kit is given in compliance matrix for ready reference to user to understand how this system is made.