Getting Good Manufacturing Practices (GMP) certified is essential for all manufacturing companies as it contributes to their success. This certification ensures manufacturing standards are met and any new products coming to market are safe for public consumption. GMP is the minimum standard for quality of production, inspection and testing of the process, equipment and facility before it can be authorized for manufacturing.
This certification ensures that manufacturing facilities fully comply with the FDA regulations and the crucial systems for producing quality dietary supplements and pharmaceuticals. It assures consumers that the final products are of high quality and appeals to the industries that need manufacturing of their products.
FDA enforces GMP regulations and manufacturers need to do everything to ensure they follow the regulations and keep the trust given to them by the consumers. They need to understand what being GMP certified is and the importance of the certification. This article will highlight what the certification is, its importance and how to get GMP Certified.
What is GMP Certification?
Manufacturing companies need to be certified as GMP compliant. This is an internationally recognized, rigorous and comprehensive industry-standard ensuring quality and safety of the manufacturing process. The GMP certification supplements offers evidence that a manufacturer adheres to the regulations established by FDA from production of raw materials to safety regulations.
The first step in achieving the certification is due diligence. Ensure your company has a diverse team with a broad range of experience, as this will give you an advantage over the competition when marketing your products in multiple markets. It is also essential to understand which areas need training and how you must carry out that training according to company standards before applying for certification.
Manufacturing companies need to be GMP compliant, which means they have met the requirements set forth by various national organizations throughout the world including labeling their products with accurate information about their active constituents and side effects. This is what the certification entails.
How to Become GMP Certified
A manufacturing facility must submit an application for certification for its products. The application process is lengthy, but the company’s benefits of achieving certification are huge. The application process includes completing a detailed questionnaire and compiling supporting documents, including premises license, manufacturing certificate, quality manual and standard operating procedures.
Here is the procedure conducted by an auditor showing how to get GMP certified.
1. Quality Systems Analysis
This is the first step in the application process for GMP compliance certification. This includes an analysis of the quality system that shows the company follows all guidelines set forth by regulatory bodies. This step also ensures monitoring, corrective and preventive actions against failure to comply with any specification and approval system for new products in development.
The auditor checks to see if the facility adheres to standard operating procedures (SOPs). The auditor also verifies the documents to avoid ambiguity and confirms that the company follows the guidelines properly.
2. Computer Systems Analysis
In this step, the auditor checks the computer systems used by your company, including the document management system and SOPs, batch information such as analytical results of finished batches, change control log and equipment maintenance schedule and data control. If there are any issues with your computer systems, they must be addressed prior to processing your application further.
3. Facilities Analysis
At this point, the auditor commences an in-depth review of your manufacturing facility, equipment and all the on-site materials. The company is audited for equipment maintenance and cleanliness of the facility and personnel. The auditor inspects the facility to ensure that the floor plan, material flow and ventilation are laid out and appropriately designed to avoid cross-contamination and infection.
4. Equipment Log Review
This step requires the auditor to review the maintenance schedule on all equipment. Ensure that the equipment is maintained according to the manufacturer’s current recommendations in an up-to-date maintenance plan. The record should include when the company performed the last preventative maintenance plus any corrective action accomplished after a failure or malfunction was noted during production.
Additionally, the facility’s warehouse is evaluated to ascertain that there are proper inventory controls accounting for all the raw materials and final products.
5. Personnel Review
This step requires an analysis of actual personnel function according to SOPs and verifying staff competency training. This helps ensure that all the necessities have been met. It is at this point that the auditor evaluates the Batch Production Records to verify the proper documentation needed essential for greater traceability.
6. Final Steps
The auditor reviews all records and reports submitted by the company in the application process to finalize the process. The company is then issued an audit report containing the auditing findings and a list of all the violations or deficiencies. The company must take the necessary measures if there are violations or deficiencies. A second audit is conducted to confirm that the corrections have been done then the GMP accreditation valid for three years is issued.
Why Good Manufacturing Practices are Important
GMP help in ensuring quality control from the moment ingredients are received to when the product is released. There are potential business-linked benefits that companies diligent in complying with the GMP regulations have, such as ensuring a safe environment for employees, contractors and visitors in and around the facility.
The certification also allows facilities to rapidly bring new products to market without having to go back and change existing processes or retool equipment. It also protects consumer health. Therefore GMP is important for various vital reasons which are:
1. Improves efficiency
Increased efficiency is what drives manufacturing companies to seek the certification. Manufacturing facilities will know how efficient their equipment and personnel are after the certification audit and take necessary actions to increase the efficiency. The quicker a facility can bring products to market, the more revenue it will generate.
2. Protects consumer health
GMP ensures that manufacturing companies use raw materials approved by the FDA. It ensures that the raw material does what it is supposed to do. It also ensures that human health and safety are protected during manufacturing and after contamination concerns.
3. Enhance consumer trust in the industry
A company gains consumer confidence and trust by being GMP certified as they can rest assured, they are purchasing products of high quality and safety with GMP compliance. Consumers prefer to purchase products produced in a GMP environment, believing they are safer than those produced under less stringent standards. A consistent product is another reason consumers prefer GMP-compliant companies over others.
4. Reduces the risk of litigation
Good Manufacturing Practices are designed to protect the company from lawsuits arising from faulty products or negligence on behalf of the manufacturer during the production and distribution of those products. The audit report helps a company identify where and what to rectify before a problem that can attract legal action arises.
5. Establishes positive brand reputation and recognition
Demonstrating your commitment to quality will build brand recognition in the marketplace and customer loyalty and trust. This will strengthen the company’s image among the employees, investors and the public.
6. Gives you access to a global market
The certification offers the opportunity to sell your products in multiple markets worldwide. It also lets your products be listed for sale on an international level with government entities such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP) and World Health Organization (WHO).
7. Avoids greater expense later
It is more costly to fix a problem after it has happened than to prevent it from occurring in the first place. In pharmaceuticals, for example, discovering a faulty batch can lead to costly recalls and even loss of reputation and market share. Therefore, being proactive in implementing a GMP program at the beginning is cost-effective.
Moreover, GMP regulation violations can lead to penalties with substantial financial ramifications, so it is essential to adhere to them always.
The Purpose of GMP Regulations
Companies meet the best systems to manufacture safe and effective goods by following GMP standards. Below are the roles of GMP regulations.
1. Prevent Damage to Health
GMP regulations are important in protecting consumers from injury and even death from defective drugs. Remember, any change to the manufacturing process can affect the safety and effectiveness of a drug. Therefore manufacturers need to evaluate changes that could impact the quality or safety of a drug and determine whether or not it meets GMP standards before making the change.
Manufacturers who do not understand their procedures well may accidentally manufacture contaminated tablets or syringes containing foreign objects such as metal pieces.
2. Improved Processes and Production Environment
GMP helps ensure all production areas are separate from those where materials are received, filled out, counted and packaged for shipment to stockists and customers. Proper hygiene is an essential part of the GMP, and all equipment must always be kept in a clean state. A GMP auditor checks to see that the manufacturer adheres to a factory hygiene protocol in all departments.
Raw material selection and processing should be kept separate from other areas for product quality and safety not to be affected by cross-contamination. This is especially important because the quality of a drug can be affected by how it is applied.
3. Lessen Complains and Avoid Recalls
GMP is crucial to ensuring production standards remain high, meaning fewer customer complaints about poor-quality products. In addition, if there is ever a need for a recall of defective products, following GMP standards will ensure the process goes smoothly.
4. Boost Export Opportunities
GMP is crucial to those who wish to export their goods to countries with similar standards. When you register your company for GMP compliance certification, you can print out your certificate and give it to potential buyers as proof that your products meet world-class manufacturing standards. This can help boost your international sales.
GMP benefits a company as it enhances consumer trust, avoids litigation risk and helps you establish a positive brand reputation and recognition. It also gives you access to a global market, protects you from more significant expenses later and ensures you avoid damaging your health through poor manufacturing practices. Please take advantage of the importance of GMP regulations described above, seek certification and register a company with the relevant authorities. This will help your company avoid faults and violations or make a positive turn.