What is GMP?
GMP stands for Good Manufacturing Practice. GMPs are the guidelines that are established by regulatory authorities on the manufacturing of drugs to ensure batch consistency and product safety. GMP certification requirements include design validation, process validation, facility validations, personnel training requirements, lot release testing requirements, complaint handling procedures, and equipment maintenance/calibration requirements.
What are the GMP Certification Requirements?
GMP certification requirements are necessary to ensure batch consistency and product safety during the manufacturing process. The GMP certification requirements for drug manufacturers include:
- Document control
- Product release testing
- Complaint handling procedures
- Equipment maintenance.
What is GMP Document Control?
GMP Documentation Control ensures all documents such as SOPs (Standard Operating Procedures), raw materials, and manufacturing/process validation records are reviewed, approved, and implemented as required. This documentation helps fulfill GMP certification requirements.
What is GMP Product Release Testing?
GMP release testing includes finished product testing as well as stability testing for most products. These GMP certification requirements ensure that the product test results meet specifications and are consistent with the history of the batch.
What are GMP Complaint Handling Procedures?
GMP compliant handling ensures all complaints such as quality defects, adverse patient reactions, and customer complaints are properly documented and investigated to determine if there was a GMP non-compliance or GMP deviation involved in the manufacturing process. GMP complaint handling procedures also include root cause analysis, corrective action implementation, and GMP compliance assessment.
Who Needs GMP Certification Requirements?
GMP certification requirements are necessary for all drug manufacturers who plan to export pharmaceutical products. GMP certification is also a requirement for any pharmaceutical company that plans to supply the US market as well as other international markets.
Importance of GMP Certification
In addition to ISO certification, GMP certification is one of the most important certifications for businesses. Meeting GMP certification requirements verifies that a company’s manufacturing process adheres to FDA or other regulatory requirements. For food producers, the objective of GMP certification requirements is to guarantee that organizations are producing safe goods while reducing the risk of contamination from hazardous ingredients and bad production processes.
What is the Process of GMP Certification through IAS?
IAS performs GMP audits for all “manufacturing establishments” to ensure that they are adhering to GMP certification requirements. This helps to indicate that the production facilities have established procedures in place to reduce the risk of contamination and maintain product integrity. The following are steps to ensure you fulfill the GMP certification requirements:
Step 1. GMP Certification Application Form
The application for GMP certification is often handled by a Production Manager, a Quality Assurance Manager, a Quality Control Manager, or the company’s managing director.
Step 2. Prepare for the audit
To enable time for you and our team to completely go through every element of your production process, plan your audit at least 8 weeks before your intended start date. Our GMP auditors will inspect every element of your facility to see if it conforms with FDA regulations and is in compliance with GMP certification requirements. It is critical that you have as many of your employees available at this time to address any questions that our auditors may have.
Step 3: Facility Inspection
On the day of the audit, our team will come to your location with all of the required equipment for an examination. This comprises cameras, measuring equipment, and other specialized instruments, but is not restricted to these. During the audit, each employee must be ready to answer any questions that our team may have as per GMP certification requirements. The areas of concentration differ considerably from one site to the next, depending on the sort of product being made and the necessary GMP certification requirements.
To ensure compliance with GMP certification requirements, 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 might take anywhere from two to five days as per GMP certification requirements. Within 24 hours following the conclusion of your GMP audit, you will receive a preliminary report. In addition, you will receive a thorough written report outlining our findings in further depth, as well as a set of instructions outlining compliance procedures for your business to meet GMP certification requirements.
Step 4: Obtaining GMP Certification
Following the end of your audit, you will have a certain amount of time to make any necessary modifications to comply with FDA regulations. After you’ve completed those GMP certification requirements, you may submit your application for a GMP certificate on our website. We’ll go over your application and paperwork to make sure you fulfill all of the GMP certification requirements. After our team has evaluated everything, we will send you an electronic and paper copy of your certificate.
A GMP audit helps you meet GMP certification requirements and enhances the overall performance of a variety of systems, including:
- The structure and amenities
- Materials management
- Control methods for quality
- Labeling and packaging for identification
- Systems for quality management
- GMP training
What are the Advantages of Meeting GMP Certification Requirements?
GMP certification requirements can help you to improve the quality of your products and increase customer satisfaction. GMP certification will also reduce product recalls, which are expensive, time-consuming, and have a negative impact on your company’s image.GMP certification requirements also help to improve accuracy in production and reduce waste. Another advantage is GMP certification can improve or create new products and services, and decrease manufacturing costs.
Costs Involved in Meeting GMP Certification Requirements
GMP certification costs depend on the size of your facility, the location, the product type, and the GMP certification requirements that you want to meet. GMP certification requirements may cost more than you expect, but it is worth the investment. IAS offers the best price for GMP certification. Contact us today for a free quotation!
GMP Certification Requirements – The Bottom Line
After reading this blog, I hope you have a better understanding of the GMP certification requirements. If your business wants to increase customer satisfaction, decrease product recalls, and improve or create new services or products, then GMP certification can be very beneficial to you.
For more information on the GMP Certification Requirements, please contact us at email@example.com.