ISO 15378:2017 Documentation Kit

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).

Documentation:-

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
10.1General
10.2 Nonconformity and corrective action
10.3 Continual improvement
Annexures
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.