GMP, or Good Manufacturing Practice, is a set of guidelines that helps ensure a manufacturer’s products are produced utilizing the highest industry standards.
Whether you’re purchasing one of our hand sanitizers or other in-house formulations, or contracting with us to manufacture a custom formulation, our goal is to deliver quality products that work optimally, are uncontaminated, protect the environment, and uphold your brand.
Our GMP certification is just another assurance that we have what it takes.
GMP vs cGMP
Seatex’s GMP certification is a Chemical GMP certification. This means that we are certified as having good manufacturing practices in the production of chemicals, but it doesn’t include food or human consumption products, which are covered under the cGMP (Current Good Manufacturing Practice) certification. Although cGMP and GMP are often used interchangeably, they are not the same.
The GMP Audit Checklist
Quality Systems
As the name implies, this category explores the strategies a manufacturer has in place to guarantee quality throughout the organization. Although the details of these systems will be unique to each company, they must be codified in writing, strictly followed, and carefully tracked and reported. This includes…
- a cleaning and sanitation schedule that includes ongoing training in best practices for sanitation and safe handling of chemicals;
- a supplier monitoring process for verifying the quality of raw materials;
- Good Laboratory Practice (GLP) regarding all tests performed and equipment used;
- documented customer complaint, product tracking, and recall procedures;
- product security for raw materials to final products; and
- a quality assessment/quality control program.
Grounds, Building, and Equipment
“Good” manufacturing is much more likely to happen in an environment that is well-kept and free of potential contaminants. This includes checking…
- the grounds have adequate drainage and are free of trash, debris, overgrown weeds, and potential pest breeding areas;
- the plant roof is sound and free of leaks;
- personnel have adequate lighting, workspace, and ventilation in which to work safely;
- equipment is well-maintained and free of rust and mold; and
- pallets are not used once broken or stored near raw materials or stored products.
Pest Control
Pests are naturally drawn to manufacturing and processing plants, so every reputable audit will dedicate time to investigating what a company is doing to keep out bugs and rodents. An audit could test whether a manufacturer…
- uses an adequate number of pest control devices across both the interior and the exterior of our facility, with only non-toxic devices inside buildings;
- checks these devices regularly;
- has no evidence of pests on or in any of our products; and
- stores any pesticides in locked, secured areas separate from product storage and processing areas.
Employee Practices
How committed a manufacturer’s team members are to their hygiene habits can have a direct impact on quality, as well as be a strong indicator of whether you should trust that company with your business. An audit may check that employees…
- have clean outer garments (such as aprons) and uniforms that don’t contribute to potential product contamination;
- adhere to our written personal hygiene standards;
- eat, drink, chew gum, etc. in only designated areas away from the manufacturing floor;
- wash their hands regularly and discarding disposable gloves after damaging them or handling potential contaminants; and
- wear hairnets/beard coverings where required.
Receiving, Storage, and Shipping
A typical chemical manufacturer has raw materials and finished products moving in and out constantly. Even so, quality needs to be assured at all times, from start to finish. An audit may check…
- shipping and receiving areas are clean and organized, and transport vehicles well-maintained;
- all substances are properly labeled and traceable in the system;
- bulk raw materials are protected from contamination as they pass into the building;
- the company follows a first-in/first-out (FIFO) rotation schedule for raw materials and finished products;
- all materials and products are properly stored under the appropriate conditions and segregated if damaged; and
- storage areas and equipment are kept clean and dry.
Plant Sanitation
An audit may examine whether…
- we use only FDA/EPA/USDA-approved cleaning chemicals, which are properly label and stored;
- our cleaning equipment is in good working order and properly stored;
- cleanliness is maintained in and on both product- and non-product surfaces and areas; and
- spills and product build-up are cleaned on a regular basis.
Manufacturing
You can’t have good manufacturing practice without certifying the actual manufacturing. An audit certifies that…
- we monitor control points (CPs) and take corrective action when necessary, and document that action;
- we have a documented sample retention program in place, with samples stored appropriately;
- we test products to ensure conformance to the specifications; and
- we keep tools, rags, gloves, etc. clean and free from processing areas.
GMP vs ISO Certification
GMP certification is quite similar to another certification that Seatex is proud to maintain: ISO 9001:2015. The ISO 9001 is an international standard that attests that a manufacturer has developed and deploys a quality management system (QMS) that helps it meet customers’ expectations. Like GMP certification, ISO certification requires intensive documentation and an audit by an independent third party.
Although ISO certification isn’t mandatory in the way that GMP certification helps us stay FDA compliant, we maintain it as yet another way to demonstrate to our customers our commitment to exceptional quality.
Turnkey Chemical Services
We bring our expertise to bear at every stage of your molecule’s life, simplifying your supply chain and giving you one point of contact. Everything we touch is backed by our dedication to our customers and our commitment to operating with integrity at all times.
Industries We Serve
Specialty Chemical
Seatex boasts the physical assets and mechanical capabilities to handle the toughest R&D and manufacturing challenges industrial companies face.
Energy
Headquartered in the heart of energy country, we are seasoned producers of fluids and additives for drilling and completion tasks.
Cleaning
We’ve handled virtually all household cleaning products, from hand care to floor care, laundry to restroom cleaners and everything in between.
Agriculture
Our formulations are employed by farmers and food producers in their nutritional, crop protection, and specialty applications.
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Seatex is a specialty chemical technology manufacturing solutions company based in Rosenberg, TX.
445 Highway 36 N Rosenberg, TX 77471
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