Changes to the regulations were initiated after the FDA received “significant adverse comments” in response to the proposals that it published in December 2007.
The report states: “We strive to give manufacturers latitude to determine how to achieve the level of control necessary for cGMP compliance, recognising that, in some instances, more direction from the FDA is necessary to provide a uniform standard to the entire industry, minimise the potential for harm, or achieve some other cGMP objective.
“We periodically reassess and revise the cGMP regulations to accommodate advances in technology and other scientific knowledge that further safeguard the drug manufacturing process and the public health.”
Reassessment of cGMP began in 1996 to ensure regulations were inline with industry practice and incorporated suitable elements of standards adhered to in the European Union.
However, owing to the FDA adopting an incremental approach to modifying its regulations the 1996 proposals were never finalised. The FDA’s latest amendments will be effective from December 8.
Among the changes will be new regulations for aseptic processing, after the FDA’s previous proposals were criticised.
The revisions seek to clarify that procedures on the validation of all aseptic processes must be included in a company’s documentation to prevent microbiological contamination of sterile drug products.
Regulations covering the use of asbestos filters have also been altered to eliminate the limited areas where their use was permitted.
Prior FDA guidelines had allowed for their use in processing injectable drug products but follwing industry responses their use has been expressly prohibited.
The other section of the regulations that has undergone significant alterations covers the need for human verification of automated equipment.
Following the FDA’s proposals made last year the Biotechnology Industry Organization (BIO) argued that automated systems with real-time alarms do not require human intervention or verification.
The FDA has taken this view into account and amended its regulations to clarify that a person is not required to repeat by hand all calculations performed by automated equipment.
Also included in the document are the FDA’s responses to comments it received from drug and biologic manufacturers, industry associations and consultants.
The document detailing the amendments can be found here.