Product Formulation means an active pharmaceutical ingredient (or combination of ingredients), dosage form and strength. Quality Control means all measures taken, including the setting of specification sampling, testing and analytical clearance, to ensure that starting material, intermediate, packaging material and Finished Pharmaceutical Products conform with established specifications for identity, strength, purity and other characteristics. Stringent Drug Regulatory Authority means a regulatory authority which is (a) a member of the ICH (as specified on its website:); or (b) an ICH Observer, being the European Free Trade Association (EFTA), Health Canada and WHO (as may be updated from time to time); or (c) a regulatory authority associated with an ICH member through a legally binding mutual recognition agreement.
Product Formulation means the developed formulation required to convert the Active Ingredient into Product.
Product Formulation means the weight fraction of all ingredients.
Examples of Product Formulation in a sentence
Product shall: be commercial brand products; have a shelf life of at least 50 days from date of manufacturer Combination Foods Combination main dish food items require a Child Nutrition (CN) Label, Product Formulation Statement (PFS), or standardized recipe.
Brands are required to submit a Supply Chain Map and a Claimed Material & Product Formulation Worksheet for each product that carries a ROC claim and contains certified material.
State should check those that apply: Submit Manufacturers Product Formulation Statement with the SEPDS (must meet USDA criteria).
These Product Formulation Statements must be made available electronically at all times amd be the most up to date statement from the manufacturer.
A Product Formulation Statement should be requested when a processed product does not have a CN Label.
More Definitions of Product Formulation
Product Formulation means the identity and the amount of each of the constituent active and inactive ingredients in the Business Product and the manner in which they are combined.
Product Formulation means each dosage form of a PRODUCT (but not each packaging presentation of a PRODUCT). For example, Oramorph SR TAB 100 mg (1 x 25 blisters) and Oramorph SR TAB 100 mg (100 count bottles) would be the same PRODUCT FORMULATION while Oramorph SR TAB 100 mg (1 x 25 blisters) and Oramorph SR TAB 60 mg (1 x 25 blisters) would be different PRODUCT FORMULATIONS.
Product Formulation. Section 8.1
Product Formulation means all processes and activities typically engaged in by a person or entity in the pharmaceutical industry for formulation and packaging of: (a) placebo tablets; and (b) the Product from the Compound; including, without limitation, vendor selection, contract negotiation, vendor management, scheduling, manufacturing process and formulation development, validation and scale-up, coating, packaging, labeling and shipping, storage, quality control and assurance, release testing, process improvement and support for inspections.
Product Formulation means all processes and activities typically engaged in by a person or entity in the pharmaceutical industry for formulation and packaging of: (a) placebo tablets; and (b) the Product from the Compound supplied (directly or indirectly) by XenoPort; including, without limitation, vendor selection, contract negotiation, vendor management, scheduling, manufacturing process and formulation development, validation and scale-up, coating, packaging, labeling and shipping, storage, quality control and assurance, release testing, process improvement and support for inspections.” * CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Product Formulation means the developed formulation required to convert the Active Ingredient into Product. PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
Product Formulation shall be as defined in Section 1.2(a).