FDA关于标签的拼版印刷和切割标签的相关规定

beiwei5du

各位蒲友，关于标签的拼版印刷和切割标签（很多企业都在使用），大家有考虑到相应的合规性要求吗？？请看下文。
FDA issues final rule for control & use of cut lables.  

Visit www.drugregulations.org for the latest from the world of Pharmaceuticals.

Due to significant problems with label mix ups and consequent recalls, FDA in 1987 and in 1990 reviewed the labeling procedures. The review of labelling and the recalls led to the conclusion that gang-printed and cut labels as the main root cause of labeling mix-ups. Gang-printing is defined in § 210.3(b)(22) as label printing from a sheet of printing material on which more than one item of labels are printed. Each sheet includes labels for a variety of products which are separated after printing. Thus when gang-printing is used, labels of different drug products or different strengths for the same drug product are printed together, making them vulnerable to mix-ups at the printers location. Similarly, cut labels are commonly placed in separate stacks and are transported. The review by FDA revealed this to be a weak process and could easily lead to mix-ups when stacks of labels of similar size, shape, and color are either printed at the printers’ location or used on the packing lines. Further if the printer or manufacturer did not detect the error, incorrectly labeled product could reach the consumer.

In 1993 FDA provided specific conditions for the use of all gang-printed and cut labels by amending the packaging and labeling control provisions of the CGMP. Under § 211.122(f), use of gang-printed labeling for different drug products, or different strengths or net contents of the same product, is prohibited unless the labeling from gang-printed sheets is adequately differentiated by size, shape, or color.
Under § 211.122(g), packaging and labeling operations must use one of three special control features if cut labeling is used（至少必须实施三种控制方案中的一种，以减少风险）:
(1) Packaging and labeling lines must be dedicated to each different strength of each different drug product;
(2) appropriate electronic or electromechanical equipment must be used to conduct a 100 percent examination for correct labeling during or after completion of finishing operations; or
(3) where labeling is hand-applied, use of visual inspection to conduct a 100 percent examination for correct labeling during or after completion of finishing operations must be performed by one person and independently verified by a second person.
FDA also requires written procedures for the identification and handling of filled drug product containers not immediately labeled (§ 211.130(b)).

In July, 1997 FDA proposed to amend the packaging and labeling control provisions of the CGMP regulations by limiting the application of above special control procedures for the use of cut labeling to （适用的范围）

·         Immediate container labels,
·         Individual unit cartons, or
·         Multiunit cartons containing immediate containers that are not packaged in individual unit cartons.

It also permitted the use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment when cut labeling—single labels for individual drug products that are ‘‘cut’’ from a sheet or roll of labels—is used.

The FDA is now implementing the final this final rule on March 20 , 2013. This action is intended to protect consumers from labeling errors more likely to cause adverse health consequences, while eliminating the regulatory burden of applying the rule to labeling unlikely to reach or adversely affect consumers. This action is also intended to permit manufacturers to use a broader range of error prevention and labeling control techniques than permitted by current CGMPs.

下文选自FDA 21cfr part 211
§211.122   Materials examination and usage criteria.(a) There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, examination, and/or testing of labeling and packaging materials; such written procedures shall be followed. 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.
(b) Any labeling or packaging materials meeting appropriate written specifications may be approved and released for use. 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.
(c) Records shall be maintained for each shipment received of each different labeling and packaging material indicating receipt, examination or testing, and whether accepted or rejected.
(d) Labels and other labeling materials for each different drug product, strength, dosage form, or quantity of contents shall be stored separately with suitable identification. Access to the storage area shall be limited to authorized personnel.
(e) Obsolete and outdated labels, labeling, and other packaging materials shall be destroyed.
(f) Use of gang-printed labeling for different drug products, or different strengths or net contents of the same drug product, is prohibited unless the labeling from gang-printed sheets is adequately differentiated by size, shape, or color.
(g) If cut labeling is used for immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons, packaging and labeling operations shall include one of the following special control procedures:
(1) Dedication of labeling and packaging lines to each different strength of each different drug product;
(2) Use of appropriate electronic or electromechanical equipment to conduct a 100-percent examination for correct labeling during or after completion of finishing operations; or
(3) Use of visual inspection to conduct a 100-percent examination for correct labeling during or after completion of finishing operations for hand-applied labeling. Such examination shall be performed by one person and independently verified by a second person.
(4) Use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment.（这个在2012年的时候又增加了一条）
(h) Printing devices on, or associated with, manufacturing lines used to imprint labeling upon the drug product unit label or case shall be monitored to assure that all imprinting conforms to the print specified in the batch production record.

[43 FR 45077, Sept. 29, 1978, as amended at 58 FR 41353, Aug. 3, 1993; 77 FR 16163, Mar. 20, 2012]

蓝雨~

全英文就不想看了。。。

懒虫9527

只看了全文的开头两端，没耐心看完。求助蒲友，谁有这个规定的翻译版？

syhorchid

谢谢分享

小金库

感谢分享。