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GMP Certification in Sri Lanka

Good Manufacturing Practice GMP Certification

Strengthen your organization’s image by implementing and understanding the guidelines of good manufacturing practices by adopting new technologies.

What is GMP Certification?

Good Manufacturing Practice is q quality standard for ensuring the manufacturing practice are consistently produced controlled and implemented according to the set quality of manufacturing products such as food, cosmetics, and pharmaceutical drugs. GMP is a practice promulgated to manufacture process and guard against any risk or contamination of the production 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 commonly known as CGMP, C stands for Current. This CGMP regulation ensures that the organization uses current and new techniques and technology for establishing the products. Enabling an organization to avoid any mix-ups, contamination, or any kind of faults in the finished product. This protects the end-user from purchasing default products affecting their health or can be dangerous causing even death. So, the manufacturers, packagers of drugs or medical devices, a certain type of food and cosmetic products establish strong quality management to protect the products from any deterioration.

Benefits of GMP Certification?

GMP guidelines and principles are customarily flexible, so countries comply with local GMP guidelines in Sri Lanka having their own legislation for the benefit of their general public as well as organization. Some benefits are:

1. Reduction in operating cost due to penalties and rework

2. Less detection of faults and errors in the process and products

3. Advantage in international trade

4.Increases company’s reliability

5. Gain competitive advantages

6. Boost credibility and brand image

7. Compliance with rules and regulation of the law

8. Awareness among employees and adaptability of a systematic approach.

Why does your organization need to implement GMP?

Implementation of GMP to 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 safe and efficacy drugs. Proper testing at each manufacturing process ensures quality assurance, good manufacturing practice, and risk management makes the products and drugs safe for usage and reduces foulness.

What are the requirements of GMP Certification?

The standard to get implemented require certain rules to follow the regulations of GMP:

  • Manufacturing processes must be clearly defined
  • Process and procedures must be clearly defined and written
  • Operators should be trained according to the guidelines of the standard
  • Proper maintenance of records of process and procedure
  • Identification of risk and errors
  • Implementing Corrective actions
  • Proper sanitation and hygiene
  • Well designed GMP complaints forum
  • Conducting inspection and regular audit
GMP Certification process in Sri Lanka

Strength of Ascent ASSOCIATES

  • We Ascent will help you to guide and implement GMP certification with the proper knowledge to your employees and staff of each level.
  • Ascent 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.
  • We Ascent follows all the ethics of the standard to get implemented accurately.
  • Ascent provides your organization with Gap Analysis before deciding the actual cost for certification.
  • We offer our services pocket-friendly with no charges hidden.
  • Ascent has well trained and experienced staff performing internal audit with 10+ years of experience in GMP in Sri Lanka.
  • Ascent minimizes non-conformities of the standard and batch recalls and adverse reports from consumers and end-users.

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.

What golden rule to be followed for GMP?

Rule1.Initially start outlying the facility.

Rule2.Develop & Confirm the process.

Rule3.Write the process and procedure.  

Rule4.Allocate the work.

Rule5.Keep regular check.

Rule6.Train the employees.

Rule7.Practice and implement good hygiene.

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 on which GMP focuses. 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. If QA/QC, Logistics are present then it is the organization’s call to implement GMP.

How much does GMP cost 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 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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