GMP Compliance

Good Manufacturing Practices (GMP) are required to conform to the guidelines recommended by agencies that regulate manufacture and sale of pharmaceutical products, medical devices and regenerative medicine therapies. These guidelines provide the minimum requirements that a manufacturer must meet to assure that the products are of high quality and do not pose a risk to the patient.

GMP guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that products are safe for human use. Regulatory agencies have legislated that pharmaceutical and medical device manufacturers follow GMP procedures and have created GMP guidelines that correspond with their regulatory requirements.

GMP guidelines relating to the manufacture of products follow a few basic principles:

• Manufacturing facilities must maintain a clean and hygienic manufacturing area.
• Environmental conditions must be controlled to prevent cross contamination of the products produced.
• Manufacturing processes should be clearly defined and controlled. Critical processes should be validated to ensure consistency and compliance with specifications.
• Instructions and procedures should be written in clear and unambiguous language. (Good Documentation Practices)
• Operators should be trained to carry out and document procedures.
• Records should be made, manually or by instruments, during manufacture to demonstrate that all the steps required by the defined procedures and instructions were followed and any deviations documented.
• Records should be retained in a comprehensible and accessible form.  They should enable the complete history of a batch to be traced.

ST3 understands the development of scalable bioreator systems for manufacturing per GMP guidelines. Our systems are developed with the following concepts at the forefront of every design:

• Our systems are designed to be wiped down or ETO sterilized to prevent micro-organism growth.
• Our bioreactor chambers and flow loops are designed as individual units so that there is no cross contamination between 3D cell cultures.  They can be designed to be sterilizable and reusable or single-use. 
• Utilizing latest generation software and electronics, process variables are controlled and documented for manufacturing repeatability and traceability.
• Due to the high degree of automation in our systems, operator interaction is minimized making training more straightforward and human error less likely.
• Record keeping is automatic due to the computerized control and monitoring our systems provide. The complete history of each product manufactured can be traced and retained in electronic format.

GMP guidelines are a series of general principles that must be observed during manufacturing. When a company is setting up its manufacturing process and quality program, there may be many ways it can fulfil GMP requirements. Whatever path you choose, ST3 can be a valuable partner in helping you to determine the most effective and efficient approach to achieving your goals.