Good manufacturing practice (GMP) is a quality assurance system and set of guidelines used by manufacturing laboratories to ensure the purity and quality of their products. In the U.S., GMP requirements are regulated and enforced by the FDA, which oversees the production and commercialization of all food and pharmaceutical products.
In particular, GMP requirements are designed to prevent cross-contamination during the process of production by creating a safe, clean, consistent production environment.
GMP labs are labs that have met GMP standards and been approved by the FDA to begin production. In addition to meeting initial GMP requirements, GMP labs must be prepared to undergo regularly scheduled and surprise inspections to maintain its GMP status.
Because GMP standards change regularly as the FDA gleens new information, current standards are referred to as CGMP, and all labs must take the initiative to update their facilities with changing CGMP regulations.
Designing a GMP lab can be a rigorous task since the FDA has a wide range of regulations regarding airflow, lab location, testing procedures, and more to ensure product quality and consistency and to protect public health. With the help of an experienced lab designer, it is possible to quickly and efficiently create a GMP compliant lab space that will be ready to begin operating in no time.
Here, we’re sharing some of the keys to designing an efficient GMP lab and offering advice on how to outfit your lab for superior cleanliness and safety.
Importance of GMP
Discussions regarding safety and procedural compliance in a lab setting are typically centered on the safety of personnel working within the facility. While ensuring all members of staff can work in safe, comfortable conditions is important, GMP standards are designed to protect public health in addition to worker safety.
Improperly produced food and pharmaceutical products can pose serious health concerns for public consumers and could leave manufacturers in hot legal water. In addition, GMP standards protect the investment made by governments and manufacturing companies by protecting the integrity of the products.
Wasted materials can be used by no one, so strictly adhering to GMP standards is beneficial to everyone.
Over time, CGMP standards evolve according to new information and improved methods of risk reduction. GMP standards are understandably different from the GMP standards of ten years ago, which is why it is vital for labs to regularly update their facilities.
What Labs Should Be GMP Compliant?
All labs involved in creating or commercializing a product or testing food, beverages, or pharmaceuticals must be GMP compliant. Products that fall under the FDA’s jurisdiction of regulation include food, drugs, medical devices, radiation-emitting products and tools, biological materials, cosmetics, veterinary and animal products, and more.
GMP compliance is for the dual purpose of protecting the consumer and the manufacturer, so it behooves all facilities to take the steps to become certified. Although the process can be a bit lengthy and expensive, the final result affords additional protection for manufacturers and consumers alike.
GMP regulations are used to govern day-to-day activities and operations and can be used as a resource for best practices and must be widely implemented and posted in writing throughout the facility.
GMP Procedures
GMP procedures are used to inform how every aspect of the manufacturing process works from the moment production begins to the moment the product is cleared for sale. GMP procedures encompass everything from training and personnel hygiene to specific equipment, materials, and laboratory design considerations.
Across the board, GMP procedures help to enforce a few key principles:
- Cleanliness & Hygiene: GMP compliant manufacturing facilities must work to maintain a hygienic environment free from contaminants, allergens, and unsafe substances that could lead to the adulteration of a product or material.
- Safety: All personnel working within a GMP lab must undergo critical safety and operational training. In addition to systems that ensure safety, GMP labs also have a series of backup and emergency procedures to handle issues that may slip through the cracks. For example, all GMP labs should have a comprehensive process firmly set in place to trace and recall all batches in the event a manufacturing error is made.
- Recordkeeping: Although the FDA performs regular and unannounced audits of GMP procedures in facilities around the country, facility staff themselves must keep unambiguous and detailed records of all procedures to prove compliance with GMP standards. Records must be made throughout the process of manufacturing and must be made available to FDA or regulatory officials during an audit or should concerns arise.
Keeping detailed records can also help to eliminate or pinpoint where issues may have occurred during manufacturing. By carefully documenting each step, staff play a critical role in maintaining product integrity and facility safety. - Consistency: Products like vaccines and pharmaceuticals must be made with the utmost consistency to ensure that they are safe for distribution and use. As such, an issue or complaint associated with products made in a GMP lab should be taken seriously and investigated to the fullest. Defective products should be recalled, and all efforts should be placed towards preventing the issue from occurring again.
Tips for Designing a GMP Lab
For new lab designers or those unfamiliar with GMP regulations and procedures, designing a GMP lab can be a bit of an overwhelming process. At OnePointe Solutions, our design team works in collaboration with experienced electricians, plumbers, and engineers to create fully integrated labs complete with everything you need to succeed.
Having helped to create and outfit countless labs, our team has picked up a few key pieces of advice for making the process of designing a GMP lab:
- Layout: Because GMP labs aim to reduce the risk of cross-contamination, GMP lab layouts should be designed to separate materials by type. Additionally, designers should aim to reduce through traffic in areas containing materials that could easily be transferred to other parts of the facility. Layout of laboratory countertops is super important, so consider it from the start.
- Equipment & Furniture: Although GMP design can be complicated, it is best to keep it simple when it comes to special equipment and furniture. Equipment should be easy to repair, relatively easy to replace, and easy to clean to prevent cross-contamination. Furniture should be made from easy to clean materials that won’t degrade with regular sanitation.
- Organization: Labeling everything, regardless of how ‘obvious’ it may seem, can help to drastically reduce accidents in the lab. Clear, unambiguous labels not only help to remind technicians what they are using but can also include tips on safety and use.
- Write Procedures: As difficult as it is to design a GMP lab, complying with GMP regulations is an equally challenging task. To help facility techs and researchers become accustomed to and regularly follow GMP procedures, consider writing procedural guides in clean, concise, easy to read formatting. Utilize tables, charts, bullet points, facts, and images to engage attention, and be sure to add as much detail as possible to reduce confusion.
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