Getting your GMP certification in Philippines will help you ensure that the products you sell will be of high quality. There are several different things that you can do to achieve this certification, including getting your products tested and evaluated, as well as undergoing on-site inspections. These are all essential things to do if you want to ensure that the products you are using will be of the best quality possible.
Desktop assessment
Obtaining GMP certification in Philippines may be done by various means. You can either do it yourself or hire a GMP consultant. It’s important to note that GMP certification in Philippines is a formal process that helps you achieve compliance with GMP guidelines.
There are a few key steps involved in obtaining GMP certification in Philippines. The first step is obtaining a valid GMP certificate from an authorized NRA. You can get one from a certification body, government, or third-party organization.
In addition, you’ll need a valid WHO GMP inspection report. You can get one from the World Health Organization’s Prequalification Inspection Program.
If you’re unfamiliar with GMP, it’s a set of guidelines and regulations designed to help you produce and test a safe product for human consumption. It covers everything from product design and testing to personnel and premises.
You may need to perform a gap assessment to determine what additional GMP certification requirements you’ll need. You’ll need to have a valid GMP certificate from an authorized PIC/S NRA and a valid GMP certificate from a PIC/S NRA listed under the ASEAN MRA on GMP.
On-site inspection
Obtaining GMP certification in Philippines requires production companies to undergo an on-site inspection. This inspection includes a review of the company’s quality systems and facilities. A specially trained inspector carries out this procedure.
Good Manufacturing Practices (GMP) are procedures that ensure the manufacturing process is controlled and products are made to meet quality standards. Its goal is to identify flaws early and prevent them from occurring. GMP also ensures that the quality of the end products is consistent.
During a GMP inspection, an inspector examines various parts of a manufacturer’s Pharmaceutical Quality System (PQS), including equipment, packaging, and facilities. The inspector also checks for any deviations from procedures. If there are severe GMP non-compliance issues, detailed investigations may be required.
The ASEAN Mutual Recognition Arrangement (MRA) on GMP Inspection is an agreement that all ten ASEAN Member States (AMS) signed in April 2009. Each AMS recognized one another’s GMP certificates and inspection reports.
Validity of GMP Clearance
A GMP Clearance is required before foreign drug manufacturers can register their products with the FDA. This ensures that their manufacturing processes align with international drug production standards. GMP is a set of measures taken to ensure drug product quality, purity and safety.
The GMP Clearance is issued after a complete on-site inspection of the drug manufacturing facility. A desktop assessment follows this. In the Philippines, this is conducted by the FDA Drug GMP Inspectorate. The on-site inspection is based on guidelines set forth by the FDA.
The FDA has released a new rule for all pending GMP applications. This rule is intended to strengthen the regulatory capacity of the health sector in the Philippines. It also aims to improve health research and establish effective health monitoring systems.
In addition to the new rule, the FDA updated the applications’ processes for initial clearance, variation clearance, and renewal. This is to ensure the accuracy and completeness of the data submitted.
How can I obtain GMP Certification in Philippines?
If you live in Philippines and want to know how to get GMP certification, Factocert is a one-stop shop that offers certification, guidance, and efficient implementation. The strategy is used to ensure that the consumer and their company receive all the benefits possible. GMP registration in Philippines is quick and easy with Factocert. You can easily contact Factocert by going to www.factocert.com and chatting with an expert or by sending an email to contact@factocert.com, and one of our experts will get back to you as soon as possible to offer the best solution on the market.
