21 Cfr Part 56 Pdf Files

21 cfr part 56 pdf files

Subpart Aā€”General Provisions. Subpart Bā€”Organization and Personnel. Subpart Cā€”Buildings and Facilities. Subpart Fā€”Production and Process Controls. Subpart Gā€”Packaging and Labeling Control. Subpart Hā€”Holding and Distribution.

Subpart Iā€”Laboratory Controls. Subpart Jā€”Records and Reports.

Title 21 Part 211

Authority: 21 U. Source: 43 FR , Sept. Back to Top. In the event of a conflict between applicable regulations in this part and in other parts of this chapter, or in parts through of this chapter, or in part of this chapter, the regulation specifically applicable to the drug product in question shall supersede the more general.

Therefore, until further notice, regulations under parts and of this chapter, and where applicable, parts through of this chapter, shall be applied in determining whether these OTC drug products that are also foods are manufactured, processed, packed, or held under current good manufacturing practice. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.

Training shall be in the particular operations that the employee performs and in current good manufacturing practice including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations as they relate to the employee's functions.

Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.

Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products. Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained.

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Records shall be maintained stating the name, address, and qualifications of any consultants and the type of service they provide. The flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building or buildings shall be designed to prevent contamination.

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There shall be separate or defined areas or such other control systems for the firm's operations as are necessary to prevent contamination or mixups during the course of the following procedures:.

If air is recirculated to production areas, measures shall be taken to control recirculation of dust from production. In areas where air contamination occurs during production, there shall be adequate exhaust systems or other systems adequate to control contaminants.

21 cfr part 56 pdf files

Water not meeting such standards shall not be permitted in the potable water system. Sewage, trash, and other refuse in and from the building and immediate premises shall be disposed of in a safe and sanitary manner.

Adequate washing facilities shall be provided, including hot and cold water, soap or detergent, air driers or single-service towels, and clean toilet facilities easily accesible to working areas. Trash and organic waste matter shall be held and disposed of in a timely and sanitary manner. Such written procedures shall be designed to prevent the contamination of equipment, components, drug product containers, closures, packaging, labeling materials, or drug products and shall be followed.

Rodenticides, insecticides, and fungicides shall not be used unless registered and used in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act 7 U. Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a good state of repair. Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.

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These procedures shall include, but are not necessarily limited to, the following:. If such equipment is so used, it shall be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance. Written records of those calibration checks and inspections shall be maintained. Input to and output from the computer or related system of formulas or other records or data shall be checked for accuracy.

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. In such instances a written record of the program shall be maintained along with appropriate validation data.

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. Filters for liquid filtration used in the manufacture, processing, or packing of injectable drug products intended for human use shall not release fibers into such products.

Fiber-releasing filters may be used when it is not possible to manufacture such products without the use of these filters. If use of a fiber-releasing filter is necessary, an additional nonfiber-releasing filter having a maximum nominal pore size rating of 0.

The use of an asbestos-containing filter is prohibited.

21 cfr part 56 pdf files

This code shall be used in recording the disposition of each lot. Each lot shall be appropriately identified as to its status i.


Specific identity tests, if they exist, shall be used. In lieu of such testing by the manufacturer, a report of analysis may be accepted from the supplier of a component, provided that at least one specific identity test is conducted on such component by the manufacturer, and provided that the manufacturer establishes the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.

Any lot of such material that does not meet such specifications shall be rejected. Components, drug product containers, and closures approved for use shall be rotated so that the oldest approved stock is used first. Deviation from this requirement is permitted if such deviation is temporary and appropriate. 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.

Such depyrogenation processes shall be validated. Portable cryogenic medical gas containers that are not manufactured with permanent gas use outlet connections e. The term does not include cryogenic containers that are not designed to be connected to a medical gas supply system, e.

21 cfr part 56 pdf files

Each such label as well as materials used for coloring medical gas containers must be reasonably resistant to fading, durable when exposed to atmospheric conditions, and not readily soluble in water. Such procedures shall include all requirements in this subpart.

These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit. Any deviation from the written procedures shall be recorded and justified. Written production and control procedures shall include the following, which are designed to assure that the drug products produced have the identity, strength, quality, and purity they purport or are represented to possess:.

If a component is removed from the original container to another, the new container shall be identified with the following information:.

Pharmaceutical GMP: 21 CFR 210-212

Each container of component dispensed to manufacturing shall be examined by a second person to assure that:. 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.

In cases where only one of a particular type of equipment exists in a manufacturing facility, the name of the equipment may be used in lieu of a distinctive identification number or code. Such control procedures shall be established to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

Such control procedures shall include, but are not limited to, the following, where appropriate:. Examination and testing of samples shall assure that the drug product and in-process material conform to specifications.

When appropriate, time limits for the completion of each phase of production shall be established to assure the quality of the drug product. Deviation from established time limits may be acceptable if such deviation does not compromise the quality of the drug product. Such deviation shall be justified and documented.

Such procedures shall include validation of all aseptic and sterilization processes. Labeling and packaging materials shall be representatively sampled, and examined or tested upon receipt and before use in packaging or labeling of a drug product. Any labeling or packaging materials that do not meet such specifications shall be rejected to prevent their use in operations for which they are unsuitable.

Access to the storage area shall be limited to authorized personnel. Such examination shall be performed by one person and independently verified by a second person. There shall be written procedures designed to assure that correct labels, labeling, and packaging materials are used for drug products; such written procedures shall be followed. These procedures shall incorporate the following features:.

21 cfr part 56 pdf files

Identification need not be applied to each individual container but shall be sufficient to determine name, strength, quantity of contents, and lot or control number of each container. Inspection shall also be made to assure that packaging and labeling materials not suitable for subsequent operations have been removed.

FDA 21 CFR Part 11 Webinar

Results of inspection shall be documented in the batch production records. The Food and Drug Administration has the authority under the Federal Food, Drug, and Cosmetic Act the act to establish a uniform national requirement for tamper-evident packaging of OTC drug products that will improve the security of OTC drug packaging and help assure the safety and effectiveness of OTC drug products.

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An OTC drug product except a dermatological, dentifrice, insulin, or lozenge product for retail sale that is not packaged in a tamper-resistant package or that is not properly labeled under this section is adulterated under section of the act or misbranded under section of the act, or both. A tamper-evident package is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred.

To reduce the likelihood of successful tampering and to increase the likelihood that consumers will discover if a product has been tampered with, the package is required to be distinctive by design or by the use of one or more indicators or barriers to entry that employ an identifying characteristic e.

A tamper-evident package may involve an immediate-container and closure system or secondary-container or carton system or any combination of systems intended to provide a visual indication of package integrity. The tamper-evident feature shall be designed to and shall remain intact when handled in a reasonable manner during manufacture, distribution, and retail display. A manufacturer or packer may request an exemption from the packaging and labeling requirements of this section.

Where new drug products for investigational use are to be reconstituted at the time of dispensing, their labeling shall bear expiration information for the reconstituted drug product. Written procedures describing the warehousing of drug products shall be established and followed.

They shall include:. Written procedures shall be established, and followed, describing the distribution of drug products. The requirements in this subpart shall be followed and shall be documented at the time of performance.

CFR - Code of Federal Regulations Title 21

Any deviation from the written specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms shall be recorded and justified. Laboratory controls shall include:. The specifications shall include a description of the sampling and testing procedures used. Samples shall be representative and adequately identified. Such procedures shall also require appropriate retesting of any component, drug product container, or closure that is subject to deterioration.

Such samples shall be representative and properly identified. Instruments, apparatus, gauges, and recording devices not meeting established specifications shall not be used. Reprocessing may be performed.