Does Your Manufacturer Follow Good Manufacturing Practices?

Apex Plastics is an FDA registered, ISO 9001:2015 plastics blow-molding manufacturer. Companies involved in the manufacture, process or packaging of medical devices, drugs for human or animals, and food intended for commercial distribution in the United States are required to register annually with the FDA. This includes contract manufacturing facilities that manufacture any of these goods to another establishment’s specifications. To our customers, these qualifications provide the assurance that they can entrust us to manufacture a safe, quality product.

Equally important to our success and our customers’ satisfaction is following Good Manufacturing Practices (GMPs)  – a key component in any company’s commitment to ensuring a safe, quality  product. We make certain that all customers are aware of the GMP guidelines that our entire staff (three shifts a day!) follows when we are manufacturing both custom and proprietary plastic bottles, containers, and shapes.

What are GMPs? A GMP is a system for ensuring that products are consistently manufactured and controlled according to quality standards. It means processes are monitored for effectiveness and to ensure consistency and compliance with specifications. GMPs impact the manufacturing, packaging, labeling, and distribution of products. The goal is simple:  to ensure consumers don’t have any safety or quality risks.

Here are a few examples of GMP guidelines:

• The buildings used to manufacture and/or store the products a company produces must be a suitable size and properly constructed. The floors, walls and ceilings must be made of material that is easy to clean and they must be kept clean.
• The equipment used in the manufacturing facility must be properly designed and constructed, as well as well-maintained.
• Production staff (both on the floor and supervisors) must be properly educated, trained, and experienced at performing the tasks assigned to them.
• The people who are in direct contact with raw materials used in the manufacturing process must wear appropriate outer garments such as gowns, gloves, and hair restraints, and maintain a suitable level of personal cleanliness as well. And, of course, there are designated areas for employees to eat, drink, or smoke within the buildings.
• Raw materials – in our company, for example, resin and colorants  – must be stored and handled so they do not get mixed up or exposed to excessive heat, cold, sunlight or moisture.
• Detailed recordkeeping is required for every step in the manufacturing process. This ranges from documenting the types, lots and quantities of material used to product labeling and  product distribution. This also includes obtaining documentation from suppliers to attest to the quality of the materials purchased. For example, when we purchase resin and colorant, we require suppliers to provide a Certificate of Analysis to affirm the quality and composition of the material being provided.

For the safety of your customers, when you are considering partnering with a blow-molder, be sure to ask about FDA registration, ISO certification, and GMPs.

If you have questions about GMPs, FDA registration or ISO certification, please call or email us. We also invite you to schedule a visit of our factory at any time.