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Documentation Requirements for ISO 15378:2015


Global Manager Group has prepared presentation to provide information about medicinal product packaging material standard - ISO 15378. It covered all the detailed information about documentation like manual, procedures, SOPs, audit checklist, etc required for ISO 15378:2015 Certification. For more information visit: – PowerPoint PPT presentation

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Title: Documentation Requirements for ISO 15378:2015

An Overview on ISO 153782015 Documentation
By Global Manager Group
What is ISO 15378?
ISO 153782015 specifies requirements for a
quality management system for manufacturers of
pharmaceutical and medical device primary
packaging materials. These organisations need to
demonstrate their ability to consistently meet
customer requirements, including regulatory
requirements and international standards
applicable to primary packaging materials for
such medicinal products.
Why is ISO 15378 Important?
The ISO 15378 Standard enables you to comply with
legal requirements for pharmaceutical and medical
device primary packaging materials. ISO 15378
integrates the requirements of ISO 9001 as well
as GMP, a regulatory requirement for the
pharmaceutical and medical device industries as
per all international regulations. The standard
also helps to reduce the risks of safety hazards
and product contamination, and ensure product
efficacy and shelf life.
Benefits of ISO 153782015 Certification
  • Helps organizations in the pharmaceutical and
    medicinal primary material packaging products
    manufacturing sector to minimize or eliminate
    instances of contamination, mix-ups, and
    manufacturing errors. Procedures Improves
    efficiency and cost effectiveness of your
    business operations.
  • Provides guidance on risk management and
  • Ensures consistently meet customer
    requirements, including regulatory requirements.
  • Additional assurance of quality products to
    your clients.
  • Enhancement in processes.
  • Evidence of adherence to legal requirements and
    contractual obligations.
  • Clear statement of the organization's
  • Saves time and costs in day to day practice as
    per GMP guidelines.
ISO 153782015 Documentation Requirements
Organizations that involved in packaging material
manufacturing for medicinal products looking for
ISO 153782015 certification, which covers
requirements of ISO 9001 with reference of Good
Manufacturing Practices(GMP). There are specific
ISO 153782015 documentation requirements that
need to be fulfill which provides better control
over implemented QMS system. . List of such
requirements for better understanding quality
system as per ISO 153782015 are as below
  • ISO 153782015 Manual
  • Procedures
  • Exhibits
  • Sample Forms and Templates
  • Standard Operating Procedures (SOPs)
  • ISO 153782015 Audit Checklist
ISO 153782015 Manual
ISO 153782015 Manual states the ISO 15378 policy
and describes the ISO 15378 system of an
organization. It may relate to an organizations
total activities or to a selected part of it,
e.g. specified requirements depending upon the
nature of products or services, processes,
contractual requirements, governing regulations
etc. It should include how ISO 153782015 system
is implemented in the organization at macro
level. ISO 153782015 manual should normally
contain, or refer to
  • Introduction
  • Management Responsibility
  • Resource Management
  • Product Realization
  • Measurement, Analysis Improvement
ISO 153782015 Procedures
ISO 15378 procedures are also called operational
procedure, as they are a snapshot of the actual
activities taking place in a company at a
particular point of time. They are considered to
be the core of the system documentation for ISO
153782015 achievement and assurance and
confidential documents. They are intended for
internal use and should be protected from misuse.
These procedures are meant to instruct in broad
terms, how the policies and objectives expressed
in the ISO 15378 manual are to be addressed and
The ISO 15378 Exhibits are very helpful tool to
teach all employees and staff about how to
implements and improvements quality requirements
for medicinal product and get number of benefits.
Following are list of Exhibits covering all the
details of ISO 153782015 requirements.
  • Skill requirements
  • Disposal of Non conforming products
  • Quality Plan
  • Document codification system
Sample Forms and Templates
Sample forms, records etc. are supporting
documents used by the company to record
information for different procedures followed.
They link the activities written in the procedure
to the records kept in the department. This
documentation serves to demonstrate that the ISO
15378 system is operating efficiently to produce
the product in accordance with specified
requirements of the ISO 153782015 system. They
should be legible, easily retrievable and
available when asked for by the auditor. On all
the forms establish proper document control on
Standard Operating Procedures
All associates have the responsibility to ensure
that all activities are performed according to
the official SOPs, any deviations in procedure
are reported to their supervisor and are
adequately documented. ISO 15378 SOPs should
provide specific step-by-step instructions for
performing operational tasks or activities.
ISO 153782015 Audit Checklist
The ISO 153782015 Audit Checklist is a good tool
or the internal to make audit questionnaire while
auditing and make effectiveness in auditing. It
covers sample audit questions based on all the
ISO 153782015 requirements. It can be used as a
very good tool for logically auditing during
internal audit for medicinal products packaging
material manufacture's certification. During
internal audit verification of system to meet ISO
153782015 requirements helps for smooth
certification audit.
ISO 153782015 Documentation Kit
Global Manager Group provides ISO 153782015
Documentation kit that having sample documents
required for ISO 153782015 Certification. It
contains all documents that covers all such
requirements standard. The ISO 153782015 manual
to ISO 153782015 audit checklist are provided in
editable format that serves as the primary source
of documentation.
For further details and free demo write us at
Global Manager Group
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and Auditor Training Packages available on
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