Issue link: https://www.e-digitaleditions.com/i/1101841
Tablets & Capsules April 2019 7 and historical use of the substance in compounded drug products. The final rule applies to compounding by licensed pharmacists in state-licensed pharmacies or federal facilities as well as licensed physicians and went into effect March 21. IPEC publishes atypical actives GMP ARLINGTON, VA— The IPEC Federation issued a position paper, "Good Manufacturing Practices for Act, placing six bulk drug substances on the 503A bulks list, which guides pharmaceutical compounders on what substances they can use. The rule also identifies four bulk drug substances that cannot be used in compounding and establishes criteria for evaluating nominated bulk drug substances for inclusion on the 503A bulks list. These criteria include physical and chemical characteriza- tion, safety issues raised, evidence of effectiveness or lack of effectiveness, Tessenderlo, Weishardt, Trobas Gelatine, India Gelatine & Chemicals, Lapi Gelatine, Junca Gelatines, Sterling Biotech, Italgelatine, and Gelnex as major market providers. industry news FDA issues 74 product-specific guidances, final rule on bulk substances SILVER SPRING, MD—The FDA published 74 product-specific guid- ances (22 new and 52 revised) that when finalized will describe the agen- cy's current thinking and expectations on how to develop generic drug prod- ucts that are therapeutically equiva- lent to specific reference-listed drugs. The majority of the revisions to these guidances provide recommendations on data standards formatting for clini- cal endpoint bioequivalence studies to align with the Clinical Interchange Standards Consortium standards. One of the draft guidances, "CDER's Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality," recommends a program that would allow stakeholders and FDA staff to propose pharmaceutical quality stan- dards for potential recognition by the agency. The program's goal is to pro- mote the development and appropri- ate use of consensus standards to help expedite pharmaceutical develop- ment and streamline the review of drug product applications. The FDA also published the draft guidance, "Quality Considerations for Continuous Manufacturing," which describes several key quality considerations and provides recom- mendations for how applicants should address them in new drug applications (NDAs), abbreviated new drug applications (ANDAs), a n d s u p p l e m e n t a l N D A s a n d ANDAs, for small-molecule, solid oral drug products that are produced via continuous manufacturing. Finally, the agency issued a final rule under section 503A of the Federal Food Drug and Cosmetic 100% Quality Vision Inspection, YES! Introducing e Enclony PLANET 6G • Designed with the latest vision technology that accurately detects tablet or capsule defects, surface damage, empty capsules, etc. • 10 2D and 2 3D inspection cameras capture entire surface area • Can inspect tablets and capsules of any shape, size, and color • Inspection output: • Up to 350,000 tablets/hour • Up to 150,000 capsules/hour • User-friendly HMI control system with smart technology • 10 minutes to clean between batches and 30 minutes for complete changeover using no tools Next Generation Visual Tablet and Capsule Inspection Machine 4 Corporate Drive • Cranbury, NJ 08512 Ph: 855-4KEYINT • info@keyinternational.com www.keyinternational.com/NEW PROCESSING EQUIPMENT: Capsule Checkweighers, Capsule Fillers, Capsule Polishers, High Shear Mixers & Granulators, Homogenizers, Metal Detectors, Rotary Tablet Presses, Tablet & Capsule Inspection, Tablet Coaters, Tablet Dedusters, Tablet Friability Testers, Tablet Hardness Testers, CORA Butterfly Valves PACKAGING EQUIPMENT: Blister Packaging, Bottle Cappers, Bottle Fillers, Bottle Inserters, Bottle Unscramblers, Cartoners, Form/Fill/Seal Pouch Fillers, Single Dose Pre-formed Plastic Shells, Stick Pack Packaging, Suppository Systems, Tablet & Capsule Counters, Tube Fillers, Key-Lon & Key-Lube One Company. One Source. Since 1968. LOOK TO KEY INTERNATIONAL FOR: