Primary packaging materials for medicinal products


This International Standard identifies Good Manufacturing Practice (GMP) principles and specifies requirements for a quality management system applicable to primary packaging materials for medicinal products. The realization of GMP principles in production and control of primary packaging materials within organizations is of great importance for the safety of a patient using the medicinal product, because of their direct product contact. The application of GMP for pharmaceutical packaging materials helps ensure that these materials meet the needs and requirements of the pharmaceutical industry.
This International Standard is an application standard for primary packaging materials, which contains the normative text of ISO 9001:2008.
The following are the conventions for the layout of this International Standard.
  • Those clauses or subclauses that are quoted directly and unchanged from ISO 9001:2008 are in boxed text.
  • Texts in italics contain additional relevant GMP information regarding primary packaging materials.
GMP terms and definitions are included in Clause 3. If listed, the source is referred to in brackets.

ISO 9001:2008, Quality management systems — Requirements

0.1   General
The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization’s quality management system is influenced by
a)   its organizational environment, changes in that environment, and the risks associated with that environment,
b)   its varying needs,
c)   its particular objectives,
d)   the products it provides,
e)   the processes it employs,
f)   its size and organizational structure.
It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.
The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement.
This International Standard can be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer, statutory and regulatory requirements applicable to the product, and the organization’s own requirements.
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.
A key objective of this International Standard is to define harmonized primary packaging material requirements. It includes some particular requirements for primary packaging materials, which are derived from Good Manufacturing Practices for the production, control, etc. of medicinal products.
Process approach

ISO 9001:2008, Quality management systems — Requirements

0.2   Process approach
This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.
For an organization to function effectively, it has to determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered a process. Often the output from one process directly forms the input to the next.
The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach”.
An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.
When used within a quality management system, such an approach emphasizes the importance of
a)   understanding and meeting requirements,
b)   the need to consider processes in terms of added value,
c)   obtaining results of process performance and effectiveness, and
d)   continual improvement of processes based on objective measurement.
The model of a process-based quality management system shown in Figure 1 illustrates the process linkages presented in Clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of this International Standard, but does not show processes at a detailed level.
NOTE   In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes. PDCA can be briefly described as follows.
Plan:   establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization’s policies.
Do:   implement the processes.
Check:   monitor and measure processes and product against policies, objectives and requirements for the product and report the results.
Act:   take actions to continually improve process performance

Figure 1Model of a process-based quality management system


fig_1.1 value-adding activities
fig_1.2 information flow
Relationship with ISO 9004
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