(1 ) Each manufacturer and packer who packages an OTC drug product (except a dermatological, dentifrice, insulin, or lozenge product) for retail sale shall package the product in a tamper-evident package, if this product is accessible to the public while held for sale.
#Control 2 release date portable#
The term does not include cryogenic containers that are not designed to be connected to a medical gas supply system, e.g., tank trucks, trailers, rail cars, or small cryogenic gas containers for use by individual patients (including portable liquid oxygen units as defined at § 868.5655 of this chapter). For the purposes of this section, a “portable cryogenic medical gas container” is one that is capable of being transported and is intended to be attached to a medical gas supply system within a hospital, health care entity, nursing home, other facility, or home health care setting, or is a base unit used to fill small cryogenic gas containers for use by individual patients. For the purposes of this paragraph, the term “manufacturer” includes any individual or firm that fills high-pressure medical gas cylinders or cryogenic medical gas containers. Portable cryogenic medical gas containers that are not manufactured with permanent gas use outlet connections ( e.g., those that have been silver-brazed) must have gas-specific use outlet connections that are attached to the valve body so that they cannot be readily removed or replaced (without making the valve inoperable and preventing the containers' use) except by the manufacturer. (1 ) Gas-specific use outlet connections. Hard copy or alternative systems, such as duplicates, tapes, or microfilm, designed to assure that backup data are exact and complete and that it is secure from alteration, inadvertent erasures, or loss shall be maintained. In such instances a written record of the program shall be maintained along with appropriate validation data. A backup file of data entered into the computer or related system shall be maintained except where certain data, such as calculations performed in connection with laboratory analysis, are eliminated by computerization or other automated processes.
#Control 2 release date verification#
The degree and frequency of input/output verification shall be based on the complexity and reliability of the computer or related system. Input to and output from the computer or related system of formulas or other records or data shall be checked for accuracy. (b ) Appropriate controls shall be exercised over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.Ĭomponent, drug product container, closure, and labeling records. Materials examination and usage criteria. Sampling and testing of in-process materials and drug products.Ĭontrol of microbiological contamination.
Rejected components, drug product containers, and closures. Retesting of approved components, drug product containers, and closures. Use of approved components, drug product containers, and closures. Testing and approval or rejection of components, drug product containers, and closures. Receipt and storage of untested components, drug product containers, and closures. Ventilation, air filtration, air heating and cooling.Īutomatic, mechanical, and electronic equipment.Ĭontrol of Components and Drug Product Containers and Closures Responsibilities of quality control unit. Current Good Manufacturing Practice for Finished Pharmaceuticals
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