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Allotrope’s Vision of the Laboratory of the Future Aligns Closely with FDA’s Regulatory Objectives, Senior Industry Players Maintain

The effort of the Allotrope Foundation to create a common lab data format that is instrument and vendor “agnostic,” allowing for more efficient and compliant analytical and manufacturing control processes, aligns closely with FDA’s lab regulatory objectives, senior industry players involved are stressing....

Comment Review, Public Meetings, Supply Chain Pilot to Follow 2014 Bolus of FDA DQSA Track & Trace Guidances

In the wake of having issued a series of guidances in the latter part of 2014 to enable implementation of the 2013 Drug Supply Chain Security Act (DSCSA), FDA is now concentrating on: ● reviewing the comments and finalizing the guidances ● issuing required regulations ● scheduling public meetings ● performing a supply chain pilot program, and ● developing a licensing program for the various trading partners in the supply chain....

Concept Paper on Revision of GMP Annex 1

A concept paper on revisions to EMA’s GMP Annex 1 on the manufacture of sterile medicinal products was published in early February. The concept paper proposes incorporating changes resulting from the adoption of ICH Q9 and Q10 as well as changes made in other EU GMP chapters.

Revised MHRA GMP Requirements for “Specials” Manufacturers

In late January, MHRA published a revised guidance on the GMP requirements for “specials” manufacturers – those who make product without a marketing authorization, similar to a compounding pharmacy in the U.S. The guidance consists of an introduction, scope, Q&A section, glossary, reference documents, and revision history. An appendix is included listing the updates to […]

Minor Changes to GMP Chapters 3 and 5

Minor changes to EU GMP chapters 3 and 5 were made in late January. Added were transitional arrangements for toxicological evaluation that come into effect in March.

Drug Controller General of India to Strengthen GMP Enforcement

In late January, the Drug Controller General of India (DCGI) said that they would expand their sample testing program to North Eastern states to better assess drug quality. DCGI had begun testing samples from public healthcare and retail pharmacies to check for quality and efficacy last year in a number of other states.

Draft CGMP Requirements for Combination Products

In late January, FDA released a draft guidance on CGMP requirements for combination products. The guidance is organized into four main sections, covering: ● background ● general considerations for CGMP compliance ● specific information on 21 CFR 4.4(b), and ● applications for specific types of combination products. The guidance fleshes out the January 2013 final rule 21 CFR […]

IPQ Monthly Update, December 2014

Headlining IPQ’s international coverage in December is the ICH Q12 effort to identify the constraints in the current quality regulatory paradigm to innovation and continual improvement across the product lifecycle and how it can be adjusted to remove them. Also in focus in the December issue are the structural and functional changes FDA is making to its center and field operations to address these constraints....

FDA Guidance Database

FDA introduced a new guidance database in early January. The database allows guidance searching based on product type or FDA office and includes whether there is an open comment period, when a guidance was issued, and if it is finalized or a draft.

New MHRA Orange and Green Guides

MHRA released the latest edition of its Orange Guide (Rules and Guidance for Pharmaceutical Manufacturers and Distributors) and Green Guide (Rules and Guidance for Pharmaceutical Distributors) in early January. The Orange Guide now includes sections on MHRAs: ● Innovation Office • Compliance and Action Group • risk-based inspection program • gold standard for Responsible Persons, […]
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