Good manufacturing practice” or “GMP” is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation.
Although there are a number of them, all guidelines follow a few basic principles.
Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
Operators are trained to carry out and document procedures.
The distribution of the drugs minimizes any risk to their quality.
Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)
A system is available for recalling any batch of drug from sale or supply.
Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented.
Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.
Good manufacturing practice” or “GMP” is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation.
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ISO 9001:2015 Certification | Quality Management System
ISO 9001:2015 is a management system that ensures all product or service processes are managed within the framework of quality principles, irrespective of the type of product or service provided. It guarantees continuity and emphasizes meeting customer needs and expectations in all sectors.
To thrive in today’s competitive market, organizations must deliver products and services that fully satisfy customer expectations. ISO 9001 quality management system is a widely preferred approach to achieving this, managing processes from design to marketing, production, service, and post-sale activities, with a focus on continual improvement.
ISO 9001:2015 Certification - Principles
- Customer focus
- Leadership
- Engagement of people
- Process approach
- Improvement
- Evidence-based decision making
- Relationship management
ISO 9001:2015 Certification - Benefits
- Boosts your image
- Increases sales
- Improves your earnings
- Lessens operational cost
- Increases customer satisfaction
- Enhances better management skills
- Maximizes efficiency
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ISO 9001 Certification (Quality Management System) from Gabriel Registrar
- A system for managing quality
- Improves efficiency and profit margins
- Proven to help win and retain business.
A quality management system is an essential tool for enhancing efficiency and increasing profit margins. Research has shown that implementing such a system can significantly contribute to winning new customers and maintaining existing ones. Gabriel Registrar, a reputable ISO Certification Body, has become the top choice for ISO 9001 Certification in numerous countries worldwide. Throughout our history, we have consistently delivered an outstanding service built on trust and assurance.
Our accreditation plays a pivotal role in instilling confidence within our valued clients. All of our ISO 9001 certificates carry the endorsement of internationally recognized accreditation bodies, providing government-backed certification that is widely acknowledged across the globe.
Every year, we certify thousands of businesses to ISO 9001. The procedure can be broken down into four simple phases and is quite simple to follow.
ISO 9001 Certification Cost
Reasons to get ISO 9001 certified
- Boosts the probability of receiving public contracts
- Improves access to private sector contracts
- Helps your business adhere to legal and regulatory standards
- May result in cheaper insurance costs
- Raises client satisfaction
- Enhances operational effectiveness
- Decreases rework and boosts profit margins
- May boost staff engagement and motivation
- Encourages ongoing development
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