CGMP Certification

The Good Manufacturing Practice (GMP) in the pharmaceutical industry is a process by which companies assure that they follow the necessary steps and procedures required for producing high-quality, safe, and effective drugs. Hence, GMP certification in Thailand is a must for any foreign pharmaceutical company that wishes to import into the country, or to manufacture and sell drugs domestically. All pharmaceutical products that are manufactured and exported from Thailand require Thai GMP and ISO certification.

The process by which manufacturers can attain such certification is understandably rigorous and arduous as it aims to ensure that drugs meet the highest quality and safety standards.

WHO-GMP Certification in Thailand

The World Health Organization (WHO) is an international public health agency that is responsible for setting global healthcare standards.

One of the many areas in which WHO provides guidance is in the area of GMP certification. WHO-GMP is an internationally recognized quality standard for the manufacturing of pharmaceutical products.

In order to obtain WHO-GMP, a manufacturing facility must comply with a number of stringent requirements, including the following:

• The quality and safety of products must be assured through rigorous testing
• The premises and equipment must be carefully maintained and controlled
• Staff must be adequately trained and qualified
• The company must have an effective quality management system in place
• Records must be kept of all products and processes

IAS verifies these criteria for WHO-GMP requirements before issuing the certification.

What An Organization Should Do To Achieve Certification?

• Call IAS for conducting a GMP Certification audit and discuss the audit procedure specific to your organization.
• Understand the requirement of GMP and Implement them in your organization before going for certification. E.g. Documenting, training the staff, practicing the system, etc
• Conduct one internal Audit program through trained Internal Auditors.
• Compile the collected data and complete the analysis.
• Conduct a Management review with the help of analyzed data and effect some decisions to improve the Organization's performance towards company objectives & goals.
• Complete the audit successfully. (Stage 1 and Stage 2)
• Closure of Nonconformance, if any.
• Collect and maintain the GMP certificate

Time required for GMP Certification

An IAS audit may take between two to four weeks, depending on the type of product being manufactured. If a facility plans to have more than one GMP certification, then the process may take longer as there are additional audits that will need to be conducted.

For instance, if an inspection is required for food products, then this process must take place before the pharmaceutical manufacturing process can begin.

For more information about the GMP Certification, contact us at enquiry@iascertification.com or Call @+6531591803