UKCA certification

UKCA CERTIFICATION

UKCA – A mandatory marking for products to be placed within the Great Britain

WHAT IS UKCA Certification?

UKCA Certification (UK Conformity Assessed) is an innovative and distinguishable identity of a product highlighting the produce intent and purpose to be placed and sold in the Great Britain market (England, Wales and Scotland).

It is mandatory that certain products, which have existing regulations, are required to bear the UKCA mark from 1 January 2023. It is imperative that the technical or essential requirements must be met, prior to application of UKCA mark. Ascent EMIRATES assists aspiring organizations to utilize the conformity assessment procedures and identify the standards that can be used to demonstrate conformity under UKCA marking or UKCA certification. These are similar to the CE marking process.

All products that fall under designated existing regulations should mandatory bear the UKCA mark. This regulatory framework covers majorly the products that previously required the CE mark. These regulations are effective from 1 January 2021, for all new products placed in the GB market. However, the products previously placed in the market as CE, will have to be replaced by UKCA mark from 1 January 2023. This timeframe has been facilitated to the manufacturers to adapt to the new obligations.

Products to be placed on the Northern Ireland market, would require the UKNI mark. The European Union authorities do not accept the UKCA mark or UKCA Certification, and hence new products that have the UKCA mark will also require CE mark to place the product in European market.

Ascent EMIRATES is expertise in the product regulations and have helped more than 65 organizations to acquire and claim conformity to apply UKCA marking in UAE. Majority of the businesses advised by Ascent EMIRATES were the aspirants of UKCA certification in Dubai. However, the businesses have started applying UKCA mark in Abu Dhabi and the other Emirates too.

Ascent EMIRATES provides complete advisory for UKCA marking in UAE, and facilitates UKCA certification that offers an open opportunity and passport for the products to enter the GB market. Ascent EMIRATES provides its services in the following product domains:

1) All products in Electromagnetic Compatibility Regulations 2016

2) Products whose essential requirements are entirely covered by UK standards and the manufacturer has actually applied & complied to these standards for Toy (Safety) Regulations 2011

3) All products in the restriction of the use of certain hazardous substances in electrical and electronic equipment regulations 2012

4) Some Class 1 devices categorized in Medical Devices Regulations 2002

5) All products where standards for regulation 6(2) are available and been applied by the manufacturer, for Radio Equipment Regulations 2017

6) All products of category 1 pressure equipment classified under The Pressure Equipment (Safety) Regulations 2016

7) All products within the range of System 4 of Construction Products Regulations (Regulation (EU) 305/2011 as brought into UK law and amended)

8) Certain categories of recreational craft as specified in the legislation for Recreational Craft Regulations 2017

9) All products that fall in The Electrical Equipment (Safety) Regulations 2016

10) Any machine which is not in Schedule 2, Part 4 of the Regulations and any machine that is in Schedule 2, Part 4 where the requirements of all relevant designated standards have been applied in full and where those standards cover the applicable essential requirements for The Supply of Machinery (Safety) Regulations 2008

11) All equipment in Group II, Equipment category 3 for The Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016

12) All products within Category 1 of personal protective equipment for Personal Protective Equipment Regulations (Regulation (EU) 2016/425 as brought into UK law and amended)

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 QUESTION

How to check UKCA marked products?

The UKCA marking will be applied to a product or its packaging. In some cases it will be applied on the manual of the product.

How long is UKCA marking valid for?

UKCA certificate does not have any particular time limit. It mostly depends on the validity of the certificates associated with the procedure of certification.

How long does it take to obtain UKCA marking?

This depends on a number of factors but generally it should take around five to six weeks to complete the procedure.

What is the cost of UKCA certification?

The cost of UKCA marking depends on a number of factors, such as the number of products, number of manufacturing locations and applied regulations etc.

What if the product already has CE marking?

The UK continues to support CE marking until the end of 2022. After that CE marking won’t be valid in the UK. It will still be required to sell products in EU countries.

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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