The recognized worldwide ISO 15378 standard specifies requirements for the quality management systems of businesses that package medical equipment. A thorough documentation system that facilitates compliance with the standard’s requirements must be established to get and preserve ISO 15378 certification. To guarantee compliance and preserve product quality, companies that produce pharmaceutical packaging materials need to have a strong and thorough documentation system in place.
Understand the Requirements of ISO 15378
The basic principles of ISO 9001 are combined with additional requirements specific to primary packaging materials in ISO 15378. Product quality, risk management, preventing pollution, and GMP compliance are important components. The cornerstone for creating a documentation system that facilitates operational procedures while guaranteeing compliance is a thorough understanding of these criteria.
Define the Documentation System’s Scope.
It is essential to specify the scope before beginning the documentation process. Think about the particular procedures, working conditions, and supplies that are used in the operations of your company. What must be documented should be explicitly identified in the scope, including:
- Superior manuals
- SOPs, or standard operating procedures
- Plans for risk management
- Records of GMP compliance
- Supplier assessments
- Product details and accountability
Organizations may make sure that their documentation system includes all the components required for compliance and operational effectiveness by clearly defining the scope.
Key Components of ISO 15378 Documentation Requirements
To control quality and guarantee GMP compliance, ISO 15378 specifies many forms of documentation. Among the ISO 15378 documents are Manual, SOPs, Work instructions, Records, Forms, Documents for Risk Management, Audit checklist, Exhibits and so on.
- ISO 15378 Manual: The primary guide that describes the QMS is the Quality Manual. It should outline the system’s organization, the goals for quality, and the roles and duties of the various departments.
- Standard Operating Procedures (SOP): SOP describes standard operating procedures for regular tasks like packaging, quality control, and manufacturing. Manufacturers do this by giving precise, easy-to-follow instructions that guarantee consistency and support the preservation of product quality.
- Work Instructions: These are specialized manual, usually intended for operators and technicians, that concentrates on certain duties or processes.
- Records and Forms: Used to record information from audits, supplier assessments, quality control inspections, and corrective and preventive measures (CAPA). Documentation is necessary to show compliance in the event of an audit.
- Documentation for Risk Management: A fundamental element of ISO 15378 is risk management. It is essential for organizations to maintain documents of their risk assessments, risk mitigation plans, and methods for controlling risks during the manufacturing process.
- Audit Checklist: The department wise and requirements wise audit checklist which includes audit questions.
Utilizing Digital Resources
- To improve the efficiency of their documentation procedures, many businesses have turned to digital solutions. Version control, distribution, and archiving can all be made easier with document management systems. Improved accessibility, quicker updates, and a stronger compliance strategy are all guaranteed by these platforms.
- Digital solutions provide the ability to trace changes made to documents, automate notifications for document reviews, and offer audit trails that prove compliance.
Education and Knowledge
It is essential for ISO 15378 training of staff members on the documentation system after it is put in place. Employees need to be aware of how crucial it is to adhere established protocols. Frequent training sessions guarantee that all staff members are informed about procedure updates and how to use forms and templates correctly.
Additionally, ISO 15378 place a strong emphasis on GMP compliance, so it’s critical to teach staff members about this particular process and emphasizes that value of risk management, contamination control, and cleanliness.
Build a Documents Control System
All documents are kept up-to-date and available to the right people with the help of a good document control system. Controlling documents involves;
- Track updates and revisions with version control
- Authorization processes for updated or new document approval
- The distribution of materials under control, ensuring that the right personnel may access them
- Preserving earlier versions while ensuring that outdated materials are removed from distribution