Being Good Manufacturing Practices (GMP) certified is vital for any manufacturing facility’s success. This certification identifies manufacturers who are fully compliant with all FDA regulations and have the necessary systems in place to produce pharmaceuticals and dietary supplements using proper quality standards and control. This certification not only appeals to industries who need their products manufactured, it also guarantees consumers that the finished products are more trustworthy and of higher quality than those without a GMP-certified product label.
While manufacturers understand the importance of GMP certification, many of them are unaware of the exact steps they need to take in order to become GMP certified. In the following article, InstantGMPTM outlines the GMP Certification process to help manufacturers better prepare for this highly desired designation.
The GMP Certification Process
After a facility submits an application for certification, the process begins with the arrival of an auditor. Once on site, the auditor performs a gap analysis to define how the facility should be operating versus how it is currently performing. This analysis involves a series of evaluations conducted by the auditor.
Quality Systems Analysis
The first area of the analysis is the facility’s quality system that maintains compliance and regulations. During this quality system evaluation, the auditor verifies that the manufacturing facility has the required Standard Operating Procedures (SOPs) in place and that these documents are clearly written and comprehensible to avoid any misunderstandings or ambiguity. Then the auditor confirms that the facility is properly following these procedures and that all operators have been trained on them as well.
Computer Systems Analysis
Once the quality system evaluation is completed, the auditor proceeds to analyze the facility’s computer system. In the course of this evaluation, the auditor determines if the computer system is validated. Although a computerized system may be in place, it’s not authorized for Good Manufacturing Practices or compliant with FDA regulations unless validation shows that it was properly designed for the facility’s exact needs and is effectively executing all of its required tasks.
Next, the auditor begins a thorough evaluation of the facility, all of its equipment and the various materials on site. First, the auditor tours and inspects the facility to make certain that its floor plan and flow of personnel, material and air are laid out and designed in ways that prevent adulteration and cross-contamination (e.g. raw materials and finished products are being transported in a single directional flow instead of crossing paths in hallways).
Equipment Log Review
After evaluating the facility’s design, all equipment logs are reviewed to verify that every tool is being properly and frequently maintained and calibrated in accordance with industry standards. Before moving on to the next phase in the process, the facility’s warehouse is evaluated to ensure that proper inventory controls are in place to account for all raw materials and finished products.
Once the facility is inspected, the auditor conducts a detailed evaluation of the facility personnel. Using the facility’s Standard Operating Procedures as a point of reference, the auditors review each operator’s training records to make sure that all the requirements have been met. Next, all Batch Production Records (BPRs) are examined to validate the proper documentation required for greater traceability.
At the conclusion of the certification process, the facility is issued an audit report that delivers the evaluation’s findings and lists all deficiencies or violations. In order to continue with the certification process, the facility must then take the necessary measures to resolve these issues. Once these matters are addressed, a second audit is performed to confirm that the facility has met all of the requirements and are in compliance with all GMP standards and FDA regulations. If so, GMP Certification is issued that is valid for up to three years.
As you can see this is a very complex process that involves strict scrutiny of a facility, its various systems, personnel and procedures. To help facilities better understand the process in greater detail, InstantGMPTM established a GMP Certification Resource Center that features additional information, a series of training videos that cover all aspects of GMP Certification, and a partners page to contact GMP Certification consultants. To learn more about how InstantGMP sets you on the right path for GMP certification, contact us today!