“Learn how proper equipment construction and cGMP compliance safeguard drug quality, ensure safety, and meet FDA regulations in pharmaceutical manufacturing.”
The pharmaceutical manufacturing industry is heavily regulated to properly ensure the safety, efficacy and quality of drug products. A key part of this process is building equipment found in factories. The regulations found under Title 21, Chapter I of the FDA, Part 211 relate to Current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals and include general requirements regarding equipment construction under Sec.211.65. This article endeavours to highlight primary requirements and industry challenges for Equipment Integrity and avoid compromises to drug product safety.
Paramount Requirements for Construction of Equipment:
Surfaces: Section 211.65(a) provides that surfaces of equipment that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive. This requirement makes sure that the equipment does not change, divert, or have an impact on the safety, identity strength quality or purity of a drug product beyond confirmed limits.
Contact of Substances:
Sec. 211.65(b) points out that when substances necessary for the operation of equipment, like lubricants or coolants are used, they should not come in contact with components; drug product containers; closures; in-process materials; and drug products. This clause is intended to prohibit the change of conditions that may change the safety, identity, strength, quality or purity of a drug product beyond what has been established.
Industry-level hurdles:
Material Selection: A significant problem with this technology is the selection of materials for equipment manufacturing. The selected materials must be suitable for use with the drug product and should not cause an interaction that could result in an impurity or loss of efficacy.
Cleaning and Validation:
Cleaning regimes for equipment must be appropriately developed as well as validated to demonstrate the absence of residues from previous production campaigns. Residues can also contaminate later processes or batches, putting the quality and safety of the drug product at risk.
The complexity of pharmaceutical manufacturing makes preventing cross-contamination between various goods or batches a major challenge. To reduce the risk of cross-contamination, manufacturers must enforce stringent cleaning procedures, the separation of equipment and protocols.
Regulatory Compliance:
Manufacturing equipment must be properly maintained and calibrated to ensure they operate as intended, complying with regulations. Improper maintenance of equipment can result in variations from product quality and safety.
Compliance with Changing Regulations:
The pharmaceutical industry is growing in a dynamic regulatory environment. Monitor changing regulations, industry standards and guidelines are essential to fully understand the construction requirements for equipment that have evolved with time.
Conclusion
This is because pharmaceutical and medical device physical safety, identity, strength quality, and purity depend on the equipment construction. For manufacturers, this means that compliance with the FDA drug-cGMP regulations included in Title 21, Chapter I, Part 211 is required to stay in c-GMP. Equipment manufacturers must understand that, only by tackling key design needs and challenges, will the pharma industry achieve consistency in its current holy grain mission of delivering quality patient products globally.
Contact us at BioBoston Consulting today or check out our website to find out how we can help you with your regulatory activities!
