TS EN ISO 22716:2013 GMP – Good Manufacturing Practice
TS EN ISO 22716:2013
TS EN ISO 22716:2013
TS EN ISO 22716:2013 GMP – Good Manufacturing Practice
Good Manufacturing Practices (GMP) is the term used to describe the complete set of procedures and principles that introduce various protective measures and standards during the production stages of products such as medicines, cosmetics, food and medical devices. Good Manufacturing Practices came into force in the European Union in 2010.
This practice is one of the fundamental approaches in the production and distribution of food products; it is a set of techniques that must be applied consistently throughout the stages of raw materials, processing, product development, production, packaging, storage and distribution in order to ensure product quality.
It is a quality approach to manufacturing which ensures the production of reliable and effective products by guaranteeing that staff in the food industry work to a professional standard.
Compliance with the general requirements of GMP is achieved through the design of the systematic network in accordance with the following elements.
Quality management,
Staff and organisation,
Buildings, fixtures and fittings, equipment and materials,
Documentation,
Raw material intake, product processing, storage and distribution,
Quality control and proficiency testing,
Approval and authorisation of all transactions,
Complaints and recalls,
Investigation of errors, post-use clinical follow-up of manufactured products,
The storage of samples, the disposal of faulty or returned products,
Internal and external audit.
Preparation and Planning
- Application: The first step is to apply to an accredited certification body for TS EN ISO 22716:2013 GMP – Good Manufacturing Practice Management System certification.
- Planning the Good Manufacturing Practice Management System: The organisation draws up a plan for the Good Manufacturing Practice Management System. This plan includes the Good Manufacturing Practice Management System’s policies, objectives and management processes.
System Setup and Implementation
- Establishment of a Good Manufacturing Practice Management System: The organisation shall establish a Good Manufacturing Practice Management System in accordance with the ISO 22716:2013 standard. This includes the monitoring, measurement and analysis of the Good Manufacturing Practice Management System.
- Monitoring and evaluating the performance of the Good Manufacturing Practice Management System: The performance indicators necessary to achieve the objectives relating to the effectiveness of the Good Manufacturing Practice Management System are identified and monitored.
Internal Audit and Management Review
- Internal Audit: The organisation carries out internal audits to assess the effectiveness of the Good Manufacturing Practice Management System and its compliance with the standard.
- Management Review: Management reviews the performance of the Good Manufacturing Practice Management System and identifies areas for improvement.
Certification Audit
-
- Independent Audit: An independent audit is carried out by the certification body to assess the organisation’s compliance with the Good Manufacturing Practice Management System and the relevant standard.
Reporting and Feedback: Audit findings are reported and feedback is provided to facilitate the necessary improvements.
