Good Manufacturing Practice - GMP
GMP is the International Standard for
Good Manufacturing Practice.
GMP: Standard for Good Manufacturing Practice
What is GMP Certification ?
GMP Certification is a term that is recognized worldwide for the control and management of manufacturing, testing and overall quality control of food and pharmaceutical products. Good Manufacturing Practice(GMP Certification) takes quality assurance approach, which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.
Features of Gmp
GMP addresses issues including documentation, record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls.
The quality approach of GMP ensures manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This, in turn, protects the consumer from purchasing a product, which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.
It is believed that GMP is a good business tool, which will help to refine both the compliance and performance of the Company. GMP requirements are largely common sense practices, which will help companies better itself as it moves toward a quality approach using continuous improvement.
GMP is also sometimes referred to as “CGMP”. The “current,” methodologies of manufacture, testing, design, and control. Manufacturers must employ technologies and systems, which are up-to-date. Systems and equipment used to prevent contamination, mixups, and errors are adequate by today’s standards.
All guidelines follow In GMP
- Hygiene: Pharmaceutical manufacturing facilities must maintain a clean and hygienic manufacturing area.
- Controlled environmental conditions in order to prevent cross-contamination of food or drug product from adulterants that may render the product unsafe for human consumption.
- Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
- 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
- Operators are trained to carry out and document procedures.
- 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 food or drug were 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.
- The distribution of the food or drugs minimizes any risk to their quality.
- A system is available for recalling any batch from sale or supply.
- Complaints about marketed products are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective products and to prevent a recurrence.
Customer satisfaction
Our Organisation Goal is to listen to Client Requirements on Priority and Delight their requirements within the timeline by providing the best services.
Reduced operating costs
Continual improvement of processes and resulting operational efficiencies mean money saved.
Improved stakeholder relationships
We have all the expertise team such as engineers, technical, environmental safety officer etc from all over India.
Proven business credentials
Independent verification against a globally recognized industry standard speaks volumes.
Ability to win more business
Procurement specifications often require certification as a condition to supply, so certification opens doors.
Global recognition as a reputable supplier
Certification is recognized internationally and accepted throughout industry supply chains, setting industry benchmarks for sourcing suppliers.
Consistent quality approach
Common approach in the supply chain for supplier or subcontractor development, driving consistency, competence and control.
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Client’s Reviews
We are extremely happy and satisfied with Geo Dimension Services for their professional service for our ISO 9001 and ISO 14001 certification. We finished our project in time and cleared audit in the 1st audit without any major non conformity. We recommend Geo Dimension Services to any company that want to take ISO certification.
Varun
Business Inc.
We are glad to write a testimonial for Geo Dimension Services who was instrumental in our organization getting ISO 9001 certification. We appreciate their efforts, dedication and seriousness for the project
Rahit Sharma
Business Inc.We have been working with Geo Dimension Services for last 5 years for our ISO 9001 certification. They are with us from our initial implementation and consulting for all the surveillance audits, recertification audits etc. we are regularly implementing our ISO 9001 QMS to various sites and locations with their consulting and they are effective.
Ajay
Business Inc.how Primor Consulting helps you