What is GMP Contract Manufacturing?
People often ask, what is GMP Contract Manufacturing? Well, Good Manufacturing Practice (GMP) is an ethical system that exists to hold products to an expected standard of quality. It was designed especially with the biotechnology and pharmaceutical vertical in mind to minimize the risks associated with production.
Current Good Manufacturing Practice regulations (cGMP) are enforced by the Food and Drug Administration (FDA) and are widely accepted as the prominent manner to conduct good business.
GMP Contract Manufacturing includes thorough checkpoints for all aspects of production including the building, raw materials, equipment, job training, labeling, and even the personal hygiene of employees. Essentially, any piece of the puzzle that can affect the overall outcome of a product requires written the detail of the correct processes and procedures with mandatory adherence to each step so that the product is consistently manufactured in every instance.
Why is GMP Contract Manufacturing so Important?
Choosing the right manufacturing facility is important to a product company as a mistake or oversight could cost your company hundreds of thousands of dollars in expenses to correct with possible court costs, fines, and risking your product losing valuable time on the market.
Choosing a manufacturer that adheres to current GMP Contract Manufacturing standards may be the solution to avoid such unfavorable outcomes.
The importance is significant to the consumer, as well. A consumer cannot always detect pharmaceutical quality (if it’s safe or effective) through taste, touch, sight or smell. And random testing on small batch samples is not enough alone to ensure product quality. Only through strict and regulated manufacturing conditions can quality be assured. With checks and cross-checks, from the condition of the machinery to the training of employees, can a reliable process and guarantee of a safe and efficient pharmaceutical product become established.
Many people may be wondering what GMP guidelines are or what an inspection checklist may include. We’ve composed an abbreviated list of what you can expect a highly trained FDA official to be looking for as they determine whether a manufacturing site can become GMP certified.
1. Building & Facilities
- Building is the correct size and structure to house materials and has an orderly storage of materials
- Floors, walls and ceilings easily cleanable and clean
- Fixtures, ducts, and pipes do not pose a threat of contamination to products
- Sufficient lighting and ventilation for intended operation
- Proper washroom facilities and sewage systems to address employee needs and facilitate personal cleanliness
- . Is of the correct material, design, and cleanliness
- All surfaces and utensils that come into contact with product are cleaned and sanitized properly
- . Supervisors have the correct training and experience
- Correct garments are worn by employees with direct contact with product
- Consumption of food and drink and tobacco is restricted to appropriate areas
4. Raw Materials
- . Organized and stored properly to avoid contamination or decomposition
- Containers are sealed and elevated off the floor
- Containers are clearly labeled
- Materials are sampled and tested and those not meeting quality standards have a system for removal
- . There are written instructions including formulas and processes for operating systems; equipment used for production is clean and sanitary
- Only approved materials are used and are being sampled for quality control and are cross-checked by secondary measures
- Labels are used and cross-checked and finished products are marked with permanent codes
6. Laboratory Controls
- . Raw materials are being checked for identity, physical and chemical properties, microbial contamination, and hazardous or other unwanted chemical contaminants
- Water supply is tested regularly
- Raw materials and primary packaging materials are documented
- Manufactured batches, finished products, sampling, distribution, shipments and code marks are all documented
- . Identifies ingredients and safety warning on labels
- Name and address of manufacturing company provided
- Any directions for safe use of product
- . Documented kind and severity of complaint or injury, the medical treatment involved, name and location of facility and physician that treated the injury
- . Checking for use of prohibited color additives or other prohibited ingredients
How to choose the right GMP Contract Manufacturing Facility
Now that the importance of using a facility that is compliant with GMP is evident, here is how to do your due diligence incorrectly identifying a GMP Contract Manufacturing facility:
- Check that the facility is registered with the Food and Drug Administration (FDA)
- The facility has been inspected by the FDA and found in compliance with current GMP standards.
- Rated by the FDA with a classification of VAI (Voluntary Action Indicated) or NAI (No Action Indicated).
- An OIA (Objectionable Activities Indicated) rating is a bad indication, it tells us the inspector found systems that were deficient or needed to be improved upon.
- Facility has a copy of the FDA Establishment Inspection Report (EIR). The inspector will have made a very lengthy (20-30 page) detailed report that will be available to the public.
- If you’re looking to sell Rx pharmaceutical products in the U.S., ensure the facility you’re considering has paid dues to the GDUFA (Generic Drug User Fee Act) that ensures US consumers have access to safe, high quality, and affordable generic drugs. This act was reauthorized through September 2022 as recently as August 18, 2017.
Current Good Manufacturing Practices and the FDA
As we now know, current Good Manufacturing Practices (cGMPs) enforced by the FDA are systematically designed to ensure proper monitoring and control of the manufacturing process. Adherence to these guidelines provides a security in the identity, quality, strength, and purity of drug products produced by manufacturers. Having strong quality management over operating systems, raw material collection, and procedures in testing laboratories benefits everyone involved from the manufacturer, to the company owning and selling the product on the shelves, to the consumer receiving the product.
As formal and strict as these regulatory guidelines sound, they are actually designed to be quite flexible in allowing the manufacturing companies to decide how best to execute the required job.
The manufacturing company may choose how best to implement the guidelines with any kind of existing modern technology or even new technology that aims to achieve higher product quality. Anything that contributes to a reduction of product contamination, mix-ups, failures, or any further kind of error is acceptable as this is the noble philosophy of the existence of cGMPs. It’s important to note that cGMPs are the minimum requirement for overall product quality and a high-end manufacturing company will aim above these basic standards to implement comprehensive, quality systems and modern risk management solutions.
What Happens if a Manufacturer is Not Following Current GMP Contract Manufacturing Standards?
Are drug products safe to use then if the manufacturer is not following current GMP Contract Manufacturing standards? If the manufacturing company is non-compliant with cGMPs the drug product will be considered what they call “adulterated” under the law. This adulteration simply means it wasn’t made in compliance with Good Manufacturing Practices.
However, regulatory actions against manufacturing companies — such as recalls, seizures, public warnings, or court cases — are all intended with the idea to protect the public from the possibility of an unsafe or ineffective drug.
What Actions can the FDA take against a current GMP Contract Manufacturing violation?
Failure to meet GMPs and/or a resulting distribution of a drug that does not work as it advertises gives the FDA a right to request a recall of the product to remove it from the market. While the FDA usually doesn’t force a company into recalling their product, companies will usually comply voluntarily with the FDA’s request. If they do not comply voluntarily, the FDA has the right to publicly warn consumers and even go about bringing a seizure or injunction case to court.
Even with no evidence of a defect affecting a drug’s performance, the FDA can bring a seizure case to court. The official language used in a seizure case is asking a federal official to take possession of an “adulterated” drug. In an injunction case, the FDA can ask the court to order the manufacturing company to stop violating GMPs. The FDA can be as severe as seeking fines, disbarment, or jail time in any case involving GMP violations.
In either of these case situations, the ending result is usually a court order for the manufacturing company in question to reform and take the necessary steps to correct any GMP violation. Generally, money must be spent to repair equipment, improve sanitation, provide additional testing materials or processes for quality control, or improve/supply additional training for employees.
As a company seeking to manufacture any kind of food, drug, cosmetic or pharmaceutical product, selecting a GMP Contract Manufacturer can help you sleep better at night knowing that your product is in good hands. As a manufacturer, selecting to follow GMP guidelines sends a message of positivity, trustworthiness, and overall goodwill to your client and target market. As a consumer of a product from a GMP Contract Manufacturer, you can be confident that the company you are purchasing from is checking all the boxes to ensure that a high-quality, safe, and effective product sits on the shelves in your grocery stores and homes.