What is GMP Certification?

Benefits of GMP Certification

Why does the Maldives need GMP Certification?

Requirements of GMP Certification

21 CFR and EU GMP

GMP Certification Process

Strength of Ascent Maldives

FAQ

GMP is the acronym for Good Manufacturing Practice. Following GMP guidelines is a strong commitment to compliance with international GMP standards. Good manufacturing practices are the practices required to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to the quality of the standard compliance. It is designed and framed to minimize the risks involved in the process of any pharmaceutical production, cosmetics, beverages, etc that cannot be eliminated or ignored in the final product.

GMP is promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act (See Chapter IV for food, and Chapter V, Subchapters A, B, C, D, and E for drugs and devices.) These regulations of the GMP standard, which have the force of the law of legal as well as a local authority, require that the manufacturers, processors, and packagers of drugs or relative dealers of medical devices considerably take proactive steps to ensure that their products are safe, pure, and effective for usage and will be effective without posing any danger to life.

1. Eliminate instances of contamination, mix-ups, and errors
2. Protects the consumer from not effective or even dangerous products
3. Address issues including record keeping of any errors or mistakes
4. Sustain the Quality of the Product
5. Increases Customer Satisfaction
6. Develops motivation among the team workers and employees
7. Continuous improvement in the process and product
8. Boost export opportunities
9. Trust build-up in the market

Maldives has a well-established fishing and tourism industry, most other products are imported but the traditional industries consist of handicrafts, boat building, and garment production also, accounting for about 7% of the GDP. The scarcity of natural resources in the Maldives has lowered manufacturing growth. Thus, Good Manufacturing Practice- GMP in Maldives becomes essential to bridge the gap.

In general, Pharmaceutical firms and biotechnology companies follow cGMP, where “c” stands for the current usage of method and technology in the manufacturing practice to ensure their products are manufactured adhering to specific requirements of GMP standards. GMP Compliance is regulated by the Food and Drug Administration (FDA).

GMP deals with all these aspects; manufacturing, storage, transport, trained personnel, appropriate laboratory facilities, approved procedures, and instructions. It is a practice that consists of processes, procedures, and documentation. GMP protects not only the companies but also the consumers.

Mostly, GMP Certification requirements are very general and open-ended that allows the manufacturer to implement necessary controls such as:

• Establish and Maintain equipment, cleaning, calibration, and validation
• Establish Laboratory Controls
• Establish Production and In-process controls
• Demonstrate Documentation and record-keeping of GMP procedures
• Establish complaint handling and Recalls team
• Conduct Internal Audit

Which Organization needs GMP Certification?

GMP is required by all Pharmaceuticals, Manufacturers of Medical devices Biotech, Bulk drug API manufactures, Formulators, and Food Processors, Bulk drug API manufacturers, Cosmetics, and other life-science industries/companies for their effective production of the products. The Certificate lasts for 3 Years and requires regular Surveillance and Re-Certification after the expiry of the GMP Certificate.

What is the 21 CFR and to whom it may concern?

Title 21 of CFR or the Code of Federal Regulations deals with food and drugs. FDA CFR Title 21 applies to organizations that deal in FDA- regulated aspects of the research, clinical study, maintenance, manufacturing, and distribution of life science products. And all these organizations have two major issues in common: first, as life science companies, they are responsible for researching and improving organism life, and second, they all need to face lots of federal regulations to remain functional. Compliance is becoming difficult because of factors like an increased emphasis on innovation, evolving needs of customers, transparency expectations, globalization, etc. If these regulations will be applied, it will become easier for organizations to work effectively. For example, Fish and Fishery Products which are the most crucial sector in the Maldives come under Standard 123 of Title 21 CFR.

What is EU GMP and to whom it may concern?

Companies that intend to sell their products and services locally or globally are required to obtain an EU GMP (Good Manufacturer Process) certificate. The EU GMP certificate displays that the applied manufacturing process meets the required standard of the EU.

These applications are required but it is not easy for beginners to arrange the process because of its complexity and time-consuming. Each application requires to differ rent way of registration. Here comes Ascent Maldives to be your guide. Contact us for your questions regarding these certifications.

• We at Ascent MALDIVES have helped over 6000 management systems to put their business in the place.
• Consultants related to this field are generally an individual who is not very responsible for an answer if problems persist after the payment. But Ascent World is one of the very few companies working as an organization and a group of experienced personnel having professional principles; we are a genuine company with authenticity meant to serve till the end.
• Ascent MALDIVES is available to help you 24X7 to solve your queries- complete hand-holding. We follow Plan-Do-Check-Act to remove hindrances in achieving the GMP Certification.
• Our successful existence in this competitive market for more than 20 years, suggests our expertise in this field itself.
• We have well-qualified professional and competent Consultants who understand your business and technical needs and can help you with the practical and pragmatic approach to developing GMP Certification standard requirements and Certification with proper guidance and training of your personnel.
• Over the years with this approach, we have been enjoying the positive market value that has helped us win numerous service awards and helps in gaining the trust of our clients and customers.
• We at Ascent do not mislead you with any hidden charges.
• We provide the best quote that suits your pocket and achieves excellence in your work.

Email your business information to mloffice@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.