Any lot of such material that does not meet such specifications shall be rejected. TITLE 21—FOOD AND DRUGSCHAPTER I—FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER C—DRUGS: GENERAL Subpart A—General Provisions § 211.1 — Scope. § 211.3 — Definitions. The reserve sample consists of at least twice the quantity necessary for all tests required to determine whether the active ingredient meets its established specifications, except for sterility and pyrogen testing. Actual finishes, levels of distressing, and fabrics may vary from product photography shown. Batch production and control records shall be prepared for each batch of drug product produced and shall include complete information relating to the production and control of each batch. Actual yields and percentages of theoretical yield shall be determined at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of the drug product.
Subpart K—Returned and Salvaged Drug Products Sec. 211.204 Returned drug products. Four adjustable floor levelers provide stability on uneven and carpeted surfaces. The requirements in this subpart shall be followed and shall be documented at the time of performance. Rejected components, drug product containers, and closures shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable. Laboratory controls shall include: (1) Determination of conformity to applicable written specifications for the acceptance of each lot within each shipment of components, drug product containers, closures, and labeling used in the manufacture, processing, packing, or holding of drug products.
All warranties are null and void if product is purchased from an UNAUTHORIZED internet dealer. Subpart D—Equipment Sec. 211.63 Equipment design, size, and location. The use of an asbestos-containing filter is prohibited.