How to Get GMP Certification in Canada

GMP Certification in Canada

GMP stands for Good Manufacturing Practice, and it is a word that is used around the world to describe the control and management of pharmaceutical product manufacturing, testing, and overall quality. It establishes a set of guidelines for the quality assurance strategy. GMP certification ensures that items are manufactured in accordance with industry standards.

The Commissioner of the Food and Drug Administration has authorized the Joint Commissioner to sign and issue certifications under the WHO-GMP certification program. Documentation, record keeping, employee qualifications, sanitation, cleanliness, equipment verification, sanitation, complaint handling, and process approval are all covered by GMP certification. This will blog will provide you with more information on how to get GMP certification in Canada for your business.

GMP Certification Online

Purpose of GMP Certification

The major goal of GMP certification is to limit the amount of risk associated with the manufacturing of pharmaceuticals. Pharmaceutical items carry risks such as: 

  • Unexpected uncleanliness in the product can have a negative impact on one’s health and even lead to death; 
  • Incorrect labels on containers implying that the patient is taking the wrong medicine, 
  • Too much active or too little ingredient, 
  • Ineffective treatment or adverse effects, etc.

GMP certification has a lot of jurisdiction, including covering all parts of manufacturing, from raw materials to specifics about locations and equipment to employee training and personal cleanliness. It contains all of the information on the methods that result in the finished product and may have an impact on its quality.

How to get GMP Certification in Canada: Preparing your Organization

Before applying for GMP certification, your organization should do the following preparatory steps:

  • Choose the best GMP standard for your product and company.
  • Recognize what is required to attain, maintain, and demonstrate GMP compliance
  • Determine which management systems are required to ensure that your facility, processes, and products comply with GMP standards.
  • Ensure that employees are completely aware of and understand their obligations in terms of GMP compliance and the required work processes.
  • Determine any current GMP non-compliance issues.
  • Submit an application, register, and have an IAS inspection for GMP certification.

How to Get GMP Certification in Canada through IAS: A Step-by-Step Process

The GMP certification Audit procedure entails an assessment of a company’s facilities and production process to ensure compliance with FDA regulations. GMP certification granted by IAS is valid for at least three years and, if necessary, can be renewed online through our website.

The Process of GMP Certification

In addition to ISO certification, GMP certification is one of the most important certifications for businesses. GMP certification verifies that a company’s manufacturing process adheres to FDA or other regulatory criteria. For food manufacturers, the purpose of GMP is to ensure that they are producing safe goods while limiting the risk of contamination from dangerous ingredients and bad production methods.

Before granting GMP certification, IAS conducts GMP audits for all “manufacturing establishments” to ensure that they are adhering to GMP guidelines. This helps to communicate that the production facilities have written procedures in place to reduce the risk of contamination and maintain product integrity for proper GMP certification.

GMP Certification Application

The application for GMP certification is typically handled by a Production Manager, a Quality Assurance Manager, a Quality Control Manager, or the company’s managing director.

Step 1: Prepare for the audit

To give time for you and our team to completely go through every component of your production process, plan your audit at least 8 weeks before your intended start date. Our GMP auditors will inspect every area of your facility to see if it conforms with FDA guidelines. It’s critical that you have as many of your employees available during this time to address any questions our auditors might have.

Step 2: Facility Inspection

On the day of the audit, our team will arrive at your location with all of the required equipment for an examination. This comprises cameras, measuring equipment, and other specialized tools, but is not restricted to these. During the audit, each employee must be present to answer any questions that our team may have. The areas of attention differ substantially from one site to the next, depending on the sort of product being created.

The auditor will look at all aspects of your business, including:

  • Manufacturing machinery and equipment
  • The facility’s physical structure
  • The facilities’ sanitization and cleanliness

Depending on your location, the audit procedure can take anywhere from two to five days. Within 24 hours following the conclusion of your GMP audit, you will receive a preliminary report. In addition, you will receive a complete written report outlining our findings in further depth, as well as a list of instructions outlining compliance actions for your business before GMP certification can be awarded.

STEP 3: Obtaining a GMP Certification

Following the end of your audit, you will have a certain amount of time to make any necessary changes to comply with FDA regulations. After you’ve completed those adjustments, you may submit your application for GMP certification on our website. We’ll go over your application and papers to make sure you satisfy all of the requirements for GMP certification. After our team has verified everything, we will send you an electronic and paper copy of your certificate.

Advantages of GMP Certification

The following are just some of the many benefits of GMP certification:

  • Identification of manufacturers and management issues in a timely manner
  • Observance of relevant rules and regulations
  • Enhance overall credibility and public perception.
  • Reduce the risk of product quality and safety being compromised.
  • Consumers will have more faith in your items as a result of this.
  • Reduces operating expenses by reducing rework and fines for non-compliance.
  • Aids in the expansion of export potential.
  • Cost savings due to less inspection duplication.

Contact IAS today to learn more about How to get GMP certification in Canada, or visit our How to get GMP certification in Canada frequently asked questions page!