FDA Proposes GMP Revisions
The US Food and Drug Administration (FDA, Rockville, MD) has proposed changes to pharmaceutical good manufacturing practices (GMPs).
The US Food and Drug Administration (FDA, Rockville, MD) has proposed changes to pharmaceutical good manufacturing practices (GMPs). The changes have been issued as a direct final rule and as proposed rules with comments due by February 19, 2008. Should no significant comments be received, the rule will be finalized on April 17, 2008.
According to the announcement in the Federal Register on December 4 (Volume 72, Number 232), the amendments being proposed are intended to “clarify and modernize the cGMP regulations, as well as harmonize the regulations with international GMP requirements and other FDA regulations.” The changes are the first set of proposed changes to parts 210 and 211.
Some of the proposed changes include:
- The addition of bioburden testing as an example of in-process testing that should be carried out (Section 211.110, Sampling and testing of in-process materials and drug products);
- Including sterilization as a way to clean equipment (Sec. 211.67, Equipment cleaning and maintenance);
- The requirement to validate procedures to prevent microbiological contamination of all aseptic processes (not just sterilization processes), in Section 211.113, Control of microbiological contamination;
- Elimination of the EPA water standard, to be replaced with a requirement that all water be “safe for human consumption;”
- Elimination of the reference to asbestos-containing filters from Sec. 211.72, Filters;
- The requirement that certain procedures be carried out by one person and checked by a second person may be satisfied by the use of an automated system, if one person verifies that the operations are performed accurately by such equipment.
Details of the proposed changes can be found on the FDA’s web site.
Proposed ruleDirect final rule
Additional analysis of the proposed changes is available from
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
Novel Modalities Spur Shift in Outsourcing Processes and Partnerships
May 8th 2025While a one-stop shop still has its advantages, sponsor companies and CDMOs are starting to see each other not as transactional relationships, but true partners with a common goal of getting drugs to patients faster.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
