Obtaining GMP certification in the Philippines would assist you in ensuring that the items you sell are of the highest quality. You can obtain this certification in a variety of ways, including by submitting your products for testing and evaluation and completing on-site inspections. These are all necessary steps to take if you want to ensure that the products you use are of the highest quality.
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There are numerous ways to acquire GMP certification in the Philippines. You have the option of doing it yourself or hiring a GMP consultant. It is essential to remember that GMP certification in Philippines is a formal process that helps you attain GMP compliance.
In the Philippines, acquiring GMP certification entails several essential processes. First, a valid GMP certificate must be obtained from an authorised NRA. You can obtain a certificate from a certification authority, the government, or a third-party organisation.
Additionally, a WHO GMP inspection record must be valid. The Prequalification Inspection Program of the World Health Organization offers them.
If you’re new to GMP, it’s a collection of principles and regulations designed to help you develop and test a safe product for human consumption. It includes everything from product development and testing to employees and facilities.
You may need to do a gap analysis to determine whether you have different GMP certification standards you must meet. You must possess a valid GMP certificate from an authorised PIC/S NRA and a valid GMP certificate from a PIC/S NRA listed in the ASEAN MRA on GMP.
Observation on-site
Production organisations must pass an on-site examination in the Philippines to obtain GMP certification. This inspection includes examining the organization’s quality management systems and infrastructure. An inspector carries out this technique with special training. Good Production Practices (GMP) are processes designed to ensure that the manufacturing process is managed and that products meet quality standards. It aims to detect faults early on and prevent their occurrence. Additionally, GMP maintains the consistency of product quality. During a GMP inspection, an inspector evaluates equipment, packaging, and facilities, among other components of a factory’s Pharmaceutical Quality System (PQS). In addition, the inspector examines any deviations from standard operating practices. Detailed investigations may be necessary if GMP violations are serious. In April 2009, the ten ASEAN Member States (AMS) signed the ASEAN Mutual Recognition Arrangement (MRA) on Good Manufacturing Practice (GMP) Inspection. Each AMS acknowledged the validity of the other’s GMP certificates and inspection reports.
GMP Certification Validity
Before registering their products with the FDA, overseas medication producers must obtain GMP Clearance. This assures that their manufacturing methods comply with international standards for the production of pharmaceuticals. GMP is a set of procedures designed to guarantee drug product quality, purity, and safety.
After a thorough inspection of the pharmaceutical production facility, the GMP Clearance is granted. Following this, a desk review is conducted. This is the responsibility of the FDA Drug GMP Inspectorate in the Philippines. FDA regulations conduct an on-site examination. For all pending GMP applications, the FDA has issued a new rule. This rule aims to increase the regulatory capability of the Philippine health sector. It also seeks to enhance health research and build efficient health monitoring systems. In addition to the new regulation, the FDA revised the application processes for initial clearance, variation clearance, and renewal. This is to confirm the completeness and correctness of the supplied data.
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