Importance of GMP in Pharmaceutical Industries

Generally, packaging material suppliers maintain an ISO 9001 quality management system. The ISO 9001 requirements, however, may not provide the necessary levels of good manufacturing practices (GMPs) and rigor to guarantee that packaging materials are suitable for their intended use.

The purpose of GMP packaging is to make sure harmful substances do not end up in food, drugs, cosmetics, medical devices, and other products. FDA regulations minimize the instances of product recalls possibly harmful side effects and lawsuits that might arise as a result of defective products. The term CGMP is used today for GMPs and has been established flexibly to allow manufacturers discretion in implementing the best controls for their organization. By making use of modern, innovative technologies, manufacturers can create products of higher quality.

GMP Principles at a Glance

Guidelines for GMP compliance with basic GMP do not constitute instructions on creating, manufacturing, labeling, storing, or distributing products. A GMP guideline is a general principle that must be followed. A quality management system should ensure that processes are controlled. Ensure compliance with GMP guidelines and general principles is the responsibility of each company.

These are some of the GMP requirements applicable to primary packaging:

• In designing, producing, quality-controlling, labeling, handling, storing, and distributing primary packaging materials, quality risk must be minimized.
• Clean and hygienic manufacturing, testing, and storage facilities are crucial.
• It is imperative that the design, operating principles, and environmental conditions of primary packaging facilities be controlled to prevent contamination.
• It is imperative that manufacturing processes are clearly defined, validated, and controlled to ensure uniformity. It is important to evaluate and validate any changes to the process from the perspective of patient safety and product quality. Any approved change that may impact the primary packaging materials should be qualified or validated.
• Work instructions (WIs) and standard operating procedures (SOPs) need to be documented clearly and unambiguously with good documentation practices (GDPs).
• The operators of primary packaging materials should be trained to follow documented and approved work instructions and standard operating procedures.
• In order to demonstrate compliance with the defined quality attributes of the primary packaging materials, records of manufacturing and quality control activities are required. Differing views should be documented and investigated.
• Product lifecycle management requires that the process is controlled and improvements are made as necessary.
• Records pertaining to a batch's manufacture, labeling, testing, and distribution should be maintained and accessible so that a complete history of a batch can be traced.
• There must be a system in place that can recall any batch from storage or distribution.
• Deficiencies in quality should be evaluated, causes of defects investigated, and steps are taken to prevent recurrences.

Summary

As a result, there can be quality issues, customer complaints, and regulatory actions without GMP packaging. To ensure that the packaging materials for medicinal products are suitable for their intended use, you will need to confirm your supplier has established, implemented, and maintains a QMS as well as consider the additional requirements of ISO 15378:2017 as part of the QMS.