ISO 15378:2017 documents contain more than 150 editable MS-Word files. These editable documents address all the elements of medicinal products packaging material manufacture’s certification.

  • A Manual
  • Required Procedures
  • Formats
  • Sample Filled Forms

Original price was: $950.00.Current price is: $900.00.



Ready-to-use templates in .doc format will reduce your time in the documentation process as well as useful in giving training to staff.

Content of ISO 15378:2017 Documentation Kit for Medicinal Product Packaging Material Manufacturers

The ISO 15378 Documentation kit – primary packaging material for medicinal products with reference to the quality management system and GMP contains a set of total 150 editable word files. All these files are based on requirements of ISO 15378:2017 standard, includes following ready made templates that can be used as a ready reference tool to accelerate the documentation process for ISO 15378 certification.

  1. ISO 15378 Manual – Editable quality manual with 08 chapters and 05 annexure for primary packaging material for medicinal products with reference of ISO 9001:2015 and GMP requirements.
  2. Mandatory Procedures – total 18 ISO 15378 procedures in word format for various process requirements for better control of the implemented system.
  3. Exhibits – sample copy of 04 exhibits that covers all the details of skill requirements and quality plans.
  4. Ready made Formats – Total 43 blank editable sample forms to maintain records as well as establish control and make the system as per QMS requirements.
  5. Process Approach – a total of 12 process approaches with flow charts that define all the details of all the departments for better implementation.
  6. Standard Operating Procedures – 61 SOPs in editable formats that required for defining standard operations as per ISO 9001 and GMP guidelines.
  7. ISO 15378 Audit Checklist – More than 500 sample audit questions for clause wise and department wise requirements, which works as a ready reference tool for quick auditing.

The ISO 15378 Documentation is developed to medicinal products packaging material manufacture’s certification as per ISO 15378:2017 requirements. Organizations involved in packaging material manufacturing for medicinal products looking ISO 15378:2017 certification, which covers requirements of ISO 9001:2015 with reference to Good Manufacturing Practices (GMP).


Our document kit is having sample documents required for ISO 15378:2017 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 organization 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 ISO 15378:2017 for and user can edit it in line with
their own processes.

1. ISO 15378:2017 Manual:

It covers sample copy of ISO 15378:2017 manual. It covers 10 chapter and 04 annexure as well as list of procedures as well as overview of covers tier 1 of ISO 15378:2017 documents.
ISO 15378:2017 Manual Index
Section – 1
1. Company profile
2. Table of contents
3. Control and distribution
Section – 2
4. Context of the Organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes
5. Leadership
5.1 Leadership & Commitment
5.2 Policy
5.3 Organizational roles, responsibilities and authorities
6. Planning
6.1 Action to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
7. Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
8. Operation
8.1 Operational planning and control
8.2 Requirements for products and services
8.3 Design and development of products and services
8.4 Control of externally provided processes, products and services
8.5 Production and service provision
8.6 Release of products and services
8.7 Control of nonconforming outputs
9. Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review
10. Improvement
10.2 Nonconformity and corrective action
10.3 Continual improvement
ANX–I List of Documented information
ANX–II Glossary of terms
ANX–III Company activity process flow chart
ANX–IV Organization structure

2. Procedures (18 Procedures):

It covers sample copy of mandatory procedures covering all the details of ISO 15378:2017.

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 Monitoring of work environment
  9. Procedure for validation of sterilization process
  10. Procedure For Monitoring And Measurement of Processes
  11. Procedure For Analysis of Data
  12. Procedure For Risk Management
  13. Procedure for customer satisfaction survey
  14. Procedure for Purchasing
  15. Procedure for Control of Non–Conforming Products
  16. Procedure for identification of products
  17. Procedure for traceability
  18. Procedure for preservation

3. Exhibits (07 exhibits).

It covers sample copy of exhibits covering all the details of ISO 15378:2017.

List of exhibits

  1. Skill Requirements
  2. Disposal of Non–conforming Products
  3. Quality Plan
  4. Document codification system
  5. Needs and Expectations of Interested Parties
  6. Communication Matrix
  7. Organizational Knowledge

4. Blank Formats (50 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. Purchase Order
  2. Indent cum Incoming inspection report
  3. Approved Vendor list cum open purchase order
  4. Supplier Registration form
  5. Calibration Status Of Instrument / Equipment
  6. Change Note
  7. Open Purchase Order
  8. Master list of records
  9. Daily Stock Statement
  10. Gate Pass
  11. Design And Development Plan
  12. Audit Plan / Schedule
  13. Quality Objective Monitoring Report
  14. Internal Audit Non–Conformity Report
  15. Design Review Minutes Of Meeting
  16. Design Verification Report
  17. Design Validation Report
  18. Breakdown History Card
  19. Preventive Maintenance Schedule
  20. Equipment Wise preventive maintenance checkpoints
  21. Order form/ confirmation
  22. Customer Complaint report
  23. Customer Feed Back Form
  24. Clause wise Document wise Audit Review Report
  25. Continual Improvement Plan
  26. Qualitative Process Monitoring Report
  27. Corrective Action Report
  28. Preventive Action Report
  29. List of license/certificate
  30. Vendor Rating
  31. Customer Property Monitoring Register
  32. Risk analysis sheet
  33. Risk identification sheet
  34. Communication report
  35. Customer Audit Summary Report
  36. Temperature & humidity monitoring record
  37. Daily Temperature monitoring record
  38. Woodent Material Checklist
  39. Label Issue Register
  40. Daily GMP Round Report
  41. Master List Cum Distribution List Of Documents
  42. Visitor Gate Pass
  43. Training Calendar
  44. Signature Sample
  45. Induction Training Report
  46. Skill Matrix for QC Personnel
  47. Training Need Cum Records Sheet
  48. Job Description and Specification
  49. Skill Matrix
  50. Training Report

5. Process approach (12 process approaches):

It covers sample copy of process approach covering all the details of ISO 15378:2017.

List of process approach

  1. Process Flow Chart of Customer Service
  2. Process Flow Chart of Design and Development
  3. Process Flow Chart of Despatch
  4. Process Flow Chart of Engineering
  5. Process Flow Chart of Marketing
  6. Process Flow Chart of Production Planning and Control
  7. Process Flow Chart of Production
  8. Process Flow Chart of Purchase
  9. Process Flow Chart of Quality Control
  10. Process Flow Chart of Risk & Opportunity
  11. Process Flow Chart of Stores
  12. Process Flow Chart of Training

5. Standard operating procedures (61 SOPs):

It covers sample copy of standard operating procedures covering all the details of ISO 15378:2017.

List of standard operating procedures (SOPs)

  1. Preventive & Breakdown Maintenance Process
  2. Rodent & Fly Control Maintenance Process
  3. Packing Process Of Alluminium Collapsible Tubes
  4. Operation & Cleaning Of Extrusion Press
  5. Operation & Cleaning Of Annealing Machine
  6. Operation & Cleaning Of Coating & Printing Machine
  7. SOP for Process For Making Purchases Of Raw Materials
  8. SOP for Operation Of Necking & Bidding Machine
  9. Manufacturing Process of Alluminium Collapsible Tubes
  10. SOP for Process For Running Capping Machine
  11. Operation & Cleaning Of Trimming Machine
  12. Operation & Cleaning Of Latex Lining Machine
  13. SOP for Process For Issuing Line Clearance
  14. Operation & Cleaning Of Lacquering Machine
  15. In-process Checking Frequency Of Different Parameters Of All Products
  16. SOP for Process For Printing Of Laminated Web
  17. SOP for SOP
  18. SOP for Receipt and Handling of Market Complaints
  19. SOP for Product recall
  20. Cleaning & Housekeeping
  21. SOP for Process For Production Of Laminated Tubes
  22. SOP for Process Of Washing For Cans
  23. SOP for Manufacturing Of Plastic Bottles
  24. SOP for Handling of market returns
  25. SOP for Control of Version, Archival and Retrieval of Data
  26. SOP for Deviation and Investigation
  27. SOP for Out of Calibration (OOC)
  28. SOP for Generation and Movement of Artwork
  29. SOP for In-process Inspection During Manufacturing
  30. SOP for Handling and storage of controlled samples
  31. SOP for Mock recall
  32. SOP for Failure investigation
  33. SOP for Fundamentals of validation sop
  34. SOP for Guidelines for area validation–clean area
  35. SOP for Handling Customer Complaint
  36. SOP for Change control system
  37. SOP for Printed product label control
  38. SOP for Vendor quality audit
  39. SOP for Out of specification (OOS)
  40. SOP for Batch release of Finished Products
  41. SOP for Rework procedure
  42. SOP for Testing And Approval Of Trimmed Tubes
  43. SOP for Retain samples and its disposal
  44. SOP for Introduction to validation
  45. SOP for Validation of HVAC system
  46. SOP for Re-validation
  47. SOP for Testing And Approval Of Lacquered Tubes
  48. SOP for Testing And Approval Of Latex Lined Tubes
  49. SOP for Leak Testing In Tubes
  50. SOP for Leakage Testing Of Laminated Tubes
  51. SOP for Testing And Approval Of Extruded Tubes
  52. SOP for Testing and Approval Of Annealed Tubes
  53. SOP for Testing And Approval Of Coated & Printed Tubes
  54. SOP for Testing And Approval Of Finished Cans
  55. SOP for Maintaining Safety Standards In Plant
  56. SOP for Receipt of Raw & Packaging Materials
  57. SOP for Receipt, Storage& Dispatch of Finished Goods
  58. SOP for Testing And Approval Of Laminated Tubes
  59. SOP for Maintaining Safety Standards In Tool Room
  60. SOP for IT
  61. SOP for Maintaining Safety Standards For Storage

7. Audit checklist (more than 800 questions)

It covers sample audit questions based on all the ISO 15378:2017 requirements. It helps the auditor to make own audit checklist for quick and perfect auditing to ensure all the ISO 15378:2017 requirements are fulfilled.

How useful?

  • Complete set of manual, procedures, process flow charts, and templates, etc., takes care for all the sections and sub-sections to get better confidence as well as improve the quality system.
  • The user can modify ready made templates as per their working system and create their own documents for quick ISO 15378:2017 certification.
  • Procedures and formats are provided in document kit can help in fine-tuning the processes and establish better control over good manufacturing practices.
  • Documentation kit saves much time and costs in document preparation.
  • It gives value for money to the customer and payback for this product is very low.
  • Ready to use templates in .doc format will increase the level of accuracy and minimize repetitive work while documentation process.


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