A New Approach to GMP Document Management: Complying with ISO 22716

For businesses in the cosmetics, pharmaceutical, and personal care industries, adhering to Good Manufacturing Practices (GMP) is essential. These practices ensure that products are consistently produced and controlled according to quality standards. One of the key international standards for GMP is ISO 22716, which offers comprehensive guidelines for production, control, storage, and shipping. However, managing these documents can be overwhelming without the right system in place.

This is where ComplierPro comes in. Our innovative GMP document management system streamlines the entire process of managing, organizing, and updating ISO 22716 documents. From ensuring compliance to providing ready-to-use templates, ComplierPro helps businesses of all sizes maintain GMP standards with ease.

Why Modernize Your GMP Document Management?

Complying with GMP requirements used to involve mountains of paperwork, manual reviews, and endless updates to stay in line with regulatory standards. These processes are not only time-consuming but also prone to errors. With ComplierPro’s GMP document management system, you can manage your entire library of ISO 22716 documents digitally, ensuring that every document is up-to-date and compliant.

Key Features of ComplierPro:

• Pre-approved Templates: Access to hundreds of GMP-compliant document templates.
• Upto Date Library: The document library is regularly updated to align with the latest regulatory changes, and notifications will be sent to inform you of these updates.
• Centralized Storage: All documents are stored securely in one place, reducing the risk of lost or outdated paperwork.
• User-Friendly Interface: Easy to use for any team member, with little to no technical knowledge required.

Money You Spend vs. Save with Our GMP Document Management System

One of the biggest challenges for companies dealing with GMP regulations is the cost of maintaining compliance. Hiring external consultants or creating and revising documents from scratch can be both time-consuming and expensive. However, by utilizing ComplierPro’s GMP document management system, you can save significant amounts of both time and money.

Imagine having access to over 6,000 pre-approved document templates, specifically tailored for GMP compliance under ISO 22716. Instead of paying a consultant or team to draft documents like “GMP audit checklist”, “GMP manufacturing procedure”, or “ISO 22716 gap analysis”, you can simply choose a template, customize it to your needs, and be done.

How You Save Money:

• No Need for External Consultants: Instead of outsourcing the creation and revision of GMP documents, use our ready-made templates.
• Reduce Time on Document Creation: Templates save time by providing a structured starting point for compliance-related documentation.
• Upto Date Startup Gallery: ComplierPro ensures that your document toolkit is updated when regulatory changes occur, and you’ll be notified accordingly to stay compliant with the latest GMP requirements.

Cost Comparison:

If you invest significant time and resources each year in creating, updating, managing compliance documents, consulting fees, and internal reviews; using a tool like ComplierPro can drastically reduce these costs. With the system’s built-in compliance checks, your team can focus on production while staying confident that your startup gallery is up to date.

How It All Works: From Registration to Compliance

The beauty of ComplierPro GMP document management system is that it’s easy to implement and can be integrated into your business with minimal effort. Here’s how the process works, from signing up to staying compliant:

Step 1: Register and Subscribe

First, you’ll need to register on our platform and choose a subscription plan that best fits your company’s needs. Whether you’re a small business or a large enterprise, our pricing plans are flexible and affordable.

Step 2: Onboarding Your Team

Once registered, you’ll receive full access to our ISO 22716-compliant document library. Our team will onboard you and provide training to key personnel in your organization. This training ensures that every department—whether it’s quality control, production, or packaging—knows how to use our system to manage their GMP documents.

Step 3: Customizing Your Document Templates

With access to over 6,000 templates, you can immediately begin customizing your documents. Simply search for the relevant document (e.g., “GMP manufacturing procedure”, “GMP audit checklist”), download the template, and edit it to fit your specific needs. The system also includes handy tools to track revisions and ensure document approval processes are followed.

Step 4: Staying Compliant with updates

ComplierPro helps you stay compliant with updates. Whenever there’s a change in ISO 22716 or GMP regulations, your documents in library are updated and notification will be sent to you to update yours accordingly, ensuring you never fall behind. This feature reduces the time and effort your team needs to spend on manual document updates.

Additional Value: More Than Just GMP Document Management

When you choose ComplierPro, you’re not just getting a GMP document management system. Our platform offers a wide range of additional modules to support other critical areas of your business. These include:

• HR Management: Manage employee records, performance evaluations, and onboarding processes.
• Risk Management: Keep track of risks and develop mitigation strategies using standardized templates.
• Finance Management: Streamline budgeting, reporting, and financial audits with pre-designed templates.
• Quality Management: Ensure that every aspect of your production meets quality standards with ISO 9001 document templates.
• Energy Management: Track and optimize your company’s energy usage, ensuring compliance with energy-related standards.

Each of these modules integrates seamlessly with the GMP document management system, giving you a holistic approach to managing your business.

What are our Startup gallery includes to comply with GMP standards and requirements?

Below is a list of the core GMP documents available within ComplierPro’ startup gallery. These templates cover everything from production and safety to audits and quality checks, ensuring that your company stays compliant with GMP requirements at all times.

GMP Manual

It covers sample copy of manual for GMPQ7 ICH Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.

List of Procedure

• Procedure for management review
• Procedure for document and data control
• Procedure for Control of Records
• Procedure for internal audit
• Procedure for Training
• Procedure for corrective and preventive action
• Procedure for Control of Monitoring and Measuring equipment’s
• Procedure for Control of Non–Conforming Products

List of process approach

It covers sample copy of process approach covering all the details of Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.

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

List of standard operating procedures (SOPs)

It covers sample copy of standard operating procedures covering all the details of Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients

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 equipment
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

List of exhibits

It covers sample copy of exhibits covering all the details of Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.

1. Skill requirements
2. Multi Skill requirements
3. Control of non–conforming products
4. Document codification system
5. Quality Plan
6. Raw material specification

List of 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.

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
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