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GMP Certification in Sri Lanka

Good Manufacturing Practice GMP Certification

Looking for a guide on GMP Certification? Here you’ll find everything you need to know about what it is, why it’s important, and how to get certified!

What is GMP Certification?

Good Manufacturing Practice is a quality standard. This is the assurance of the quality of the manufacturing practices of an organization. It is effective for the consistent production and controlled implementation of activities accordingly.

GMP Certification in an organization keeps a tag over the quality of manufactured products such as food, cosmetics, and pharmaceutical drugs.

The GMP Standard focuses upon the manufacturing processes. The standard also provides protection against different types of risks or contaminants associated with the production.

The guidelines of the GMP Certification are proposed by the Federal Food & Drugs Administration (FDA) under Food Drug Cosmetic Act (Chapter IV for food Chapter V(A) (B) (C) (D) (E) for Devices and Drugs.

GMP is also known as CGMP. In this case, C stands for Current. This CGMP regulation certifies that an organization is using verified techniques and technology for manufacturing different products.

This international certification allows an organization to avoid different types of mix-ups, contaminations, or associative faults while manufacturing different products.

GMP Good Manufacturing Practice protects the end-users from purchasing default products that may affect their health or cause dangerous diseases, even death. So, the manufacturers, packagers of drugs & medical devices, and cosmetic production houses establish strong quality management systems to protect their products from any deterioration.

Benefits of GMP Certification?

GMP guidelines and principles are customarily flexible. So, GMP Certification in Sri Lanka will offer the same benefits to an organization. Here is the list of benefits:

Compliance with Legal Requirements: Once an organization satisfies the terms and conditions of the GMP standard, it brings a lot of advantages and avoids different penalty situations due to the lack of quality in production.

Hygiene Production: Better and improved methods of preparation, the latest technology, processed production, and much more productive activities are the phases of this standard.

Better Awareness: The standard increases improved awareness among the users, employees, and the production unit itself. It harvests a great and controlled environment suitable for the manufacturing of products.

Competitive Advantage: With GMP Certification, an organization gets the best opportunities to beat its competitors effortlessly.

Motivation for Employees: The management and working personnel of an organization gets the appropriate idea about the GMP standard through training. So, they will be motivated to maintain all requisite activities for quality management.

Apart from that GMP Certification can generate the following attributes:

  • Reduction in operating costs due to penalties and rework
  • Less detection of faults and errors in the process and products
  • The advantage of international trade
  • Increases company’s reliability
  • Gain competitive advantages
  • Boost credibility and brand image
  • Compliance with the rules and regulations of the law
  • Awareness among employees and adaptability of a systematic approach.

Why does your organization need to implement GMP?

Implementation of GMP in your organization not only has a positive impact financially but also facilitates the clean and hygienic process at each stage. It reduces and minimizes the risk involved in the production and distribution of drugs, food, or cosmetic products in the market. A consumer cannot judge the product by seeing that the drug or the product will be safe for use. Therefore a manufacturer must take initiative in providing the consumer with safe and efficacy drugs. Proper testing at each manufacturing process ensures quality assurance, good manufacturing practices, and risk management makes the products and drugs safe for usage and reduce foulness.

What are the requirements of GMP Certification?

The standard to get implemented requires certain rules. In GMP Requirements, the following regulations will be involved:

  • Clear Elaboration of Manufacturing processes
  • Follow Legit Methods and Protocols Mentioned as per the GMP Standard.
  • Training Sessions of Operators should as per the GMP guidelines.
  • Following the maintenance and Documentation of the production.
  • Identification of risk and errors
  • Implementing Corrective actions
  • Proper sanitation and hygiene
  • Well-designed GMP complaints forum
  • Conducting inspection and regular GMP Certification Audit
GMP Certification process in Sri Lanka

Strength of Ascent ASSOCIATES

  • Ascent ASSOCIATES will help you to guide and implement GMP Certification with the proper knowledge to your employees and staff of each level.
  • Ascent ASSOCIATES as a part of your organization’s family gives you a helping hand throughout the process.
  • Ascent ASSOCIATES is available 24X7 to cater to the customers’ and clients’ needs.
  • Ascent ASSOCIATES follows all the ethics of the standard to get implemented accurately.
  • Ascent ASSOCIATES provides your organization with Gap Analysis before deciding the actual cost for certification.
  • Ascent ASSOCIATES offers our services as pocket-friendly with no charges hidden.
  • Ascent ASSOCIATES has well-trained and experienced consultants who can do internal audits and GMP Audit in Sri Lanka precisely.
  • Ascent ASSOCIATES minimizes non-conformities of the standard and batch recalls and adverse reports from consumers and end-users.
  • Apart from all; We offer the following Unique Selling Points (USPs):
    • International reputation
    • Higher expertise
    • Knowledgeable consultants.
    • Gain technical and advanced-level approaches
    • Skilled professionals.
    • Certification is guaranteed.
    • 100% success rate with higher credibility
    • 24×7 support system activated
    • Ascent ASSOCIATES is not working under a few temporary individuals or hiring outsiders to do your work. The result is assured with us.
    • We are the best consultancy agency in Sri Lanka.

Email your business information to info@ascentasscociates.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.

Is GMP certification mandatory?

GMP protects the product from any defect and maintains consistency in quality. People, processes, premises, products, and procedures including paperwork are 5PS (GMP Principle) on which it focuses.

In certain regulated segments, a product can be considered “adulterated” if the product breaches or does not obey current good manufacturing guidelines which have passed all the specified tests. Therefore, GMP is mandatory in such areas. If QA/QC, Logistics are present then it is the organization’s call to implement GMP.

What golden rule to be followed for GMP?

Rule 1: Initially start outlying the facility.

Rule 2: Develop & Confirm the process.

Rule 3: Write the process and procedure.

Rule 4: Allocate the work.

Rule 5: Keep regular check.

Rule 6: Train the employees.

Rule 7: Practice and implement good hygiene.

What is the GMP Certification Cost in Sri Lanka?

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 of the organization.

Who is accountable for GMP?

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

How does an Good Manufacturing Practices (GMP) certification scheme works?

Good Manufacturing Practices (GMP) certification scheme works based on the Sri Lanka Standards on codes of practice available in the related discipline.

Areas focused to be monitored while implementing GMP in an organization:

 

  • Establishment – Design, facilities, equipment, and maintenance
  • Control of operations
  • Cleaning and sanitation
  • Personal hygiene
  • Transportation
  • Training
  • Product certification
  • Pest control
  • Waste management
  • Packaging and labeling etc

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