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gmp certification

GMP Certification

Get your goods a certification of surety by GMP certification for the welfare of the consumer.

What is GMP Certification?

GMP Certification Good Manufacturing Practice was introduced by the Food & Drugs Administration (FDA) under Food Drug Cosmetic Act (Chapter IV for food Chapter V(A)(B) (C)(D)(E) for Devices and Drugs. The acts and provisions require that all manufacturers, processors, packagers of drugs, and medical devices take appropriate steps to verify their manufactured products are safe, effective, unadulterated, and non-toxic for the consumers.

GMP is sometimes also known by cGMP, where c stands for “current”. It signifies that the manufacturer uses current techniques, methodologies of testing, design, and controls. So the manufacturer should use up-to-date systems and technology to avoid mix-ups, contaminations, and errors as per required standards. This finally protects the end-users from buying a product that may be not effective or safe.

GMP addresses issues regarding equipment verification, cleanliness, record-keeping, packaging, labelling, validation of processes, personnel qualification, competence, and even complaint handling. To maximize the yield from GMP system implementation, the manufacturer is required to adopt a more practical approach rather than a generic one in implementing the guidelines and regulations. The standard has been designed in a pattern that maximizes the proactive control of deterioration of food & drugs.

Why you should implement GMP Certification

The main motive of this standard is to reduce the amount of risk involved in manufacturing, distribution, or dealing with cosmetics, pharmaceuticals, and medical products. The risk involved in these verticals can vary from unexpected mistakes in the product’s labels on containers which may result in the patient consuming the incorrect medicine, to too much or too few ingredients, causing ineffective treatment can cause patients’ death or adverse effects. GMP is basically a standard that assures the quality of the product and all technical specifications of the product are controlled and are processed strictly by following the demand of the established standards.

Benefits of GMP Certification

1. Timely identification of mistakes in the process.

2. Builds consumer confidence in the long term.

3. Reduce in cost in detecting errors

4. Better compliance of rules and regulations with relevant law.

5. Enhance brand image and creditability.

6. Enables employees to develop healthy operational habits.

7. Boon from its competitors.

8. Increase in management capabilities inadequate and assured safety measures.

9. The manufacturing process must be clean and hygienic.

10. Improves organizations’ method of handling issues and non-conformities.

Principles of GMP Certification

The basic is to implement a Quality Management System as per regulatory requirements of the “Code of Federal Regulations”.

1. The manufacturing process must induce a neat and hygienic manufacturing area.

2. Directions and procedures must be written down in a clear, unambiguous, and obvious manner.

3. A system must be made available for the safety checking process for compliance with guidelines.

4. Manufacturing processes must be controlled and consistently monitored, and any changes that influence the quality of the drug must be validated as necessary.

5. Product Master Device documentation to be developed and maintained.

GMP protocols are not only instructions on how to manufacture products. They are also principles that must be fulfilled while the manufacturing process of the products. In numerous ways,a facility can set up quality programs and manufacturing processes to fulfil GMP requirements.

Is GMP Certification mandatory?

Good quality can be implemented right from the first step process of manufacturing and at each further step. If a quality control laboratory is there in the organization, still GMP Certification is necessary.

GMP helps to protect the end product from errors that cannot be ignored further. Without such a management system in place, it would get tougher to ascertain that everysingle unit of product is of the same and consistent quality as the units tested in the research.

For enhanced effectiveness of these processes, GMP focuses on 5 key elements oftendefined as 5P’s people, processes, premises, products, and procedures including paperwork. Practices are recommended to safeguard the health of consumers and patients by providing them good quality products. In certain regulated segments, a product can be considered “adulterated” if the product breach or does not obey current good manufacturing guidelines which although has passed all the specified tests. Therefore, GMP is mandatory in such areas. It is the manufacturer’s authority to decide the most efficient and effective quality process during manufacturing, QA/QC, Logistics, and general factory management.

Strength Of Ascent Emirates

Ascent imparts correct education regarding coordination of management and employees helps in achieving GMP. Our expert professionals adapt well-defined process smart methods to implement and supervise. In existing businesses, the Ascent methodology involves the integration of the existing system in a synchronized manner rather than building it right from scratch which might have other ill-effects. Through advanced & proactive thought-processes, we help in determining the errors before they occur. Ascent Emirates works 24X7 (even on odd days) to cater to the customer needs of the whole world. Ascent facilitates rigorous and in-depth professional training. Our professionals offer sufficient guidance with a clean-budget and knowledge with no single penny more and no hidden expenses.

Email your business information to info@ascentworld.com or make an appointment for a meeting. After evaluating your business we will get you the real cost, involvement patterns, and timelines, for implementing and acquiring GMP certification.

Frequently Asked Questions

What does GMP Conformity means?

Good Manufacturing Practice (GMP) is a system for verifying the quality of the products. It is planned to consistently control and improve the quality of the products. It also minimizes the risk involved that cannot be eradicated through testing. 

What golden rule to be followed for GMP?

Rule1: Initially start outlaying the facility.

Rule2: Develop & confirm the process.

Rule3: Write the process and procedure. Develop Product details Master File.    

Rule4: Allocate the work.

Rule5: Keep a regular check.

Rule6: Train the employees.

Rule7: Practice and implement good hygiene.

Who is accountable for GMP?

GMPs are applied under Title 21CFR by the Food and Drug Administration (FDA). The regulation uses cGMP means current good manufacturing practice to set out their guidelines.

How much does GMP Certificationcost to an organization?

According to the FDA amendment cost differ for small scale companies (less than 20 employees) and companies (more than 20, but lesser than 500 employees). Usually, it depends on the size and products of the organization.

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