GMP/ISO Quality Audit Manual for Healthcare Manufacturers by Leonard Steinborn

GMP/ISO Quality Audit Manual for Healthcare Manufacturers by Leonard Steinborn

By Leonard Steinborn

Quantity 2 of this set includes the entire textual content of the FDA laws, EC and IPEC directions, and ISO/BSI criteria referenced within the checklists provided in quantity I. The e-book is gifted in an handy, easy-to-read layout, prepared to supply quick entry to the information and laws of curiosity.

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Extra info for GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, Sixth Edition,

Example text

E) Obsolete and outdated labels, labeling, and other packaging materials shall be destroyed.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, 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.

B) Components, drug product containers, and closures shall be stored under quarantine until they have been tested or examined, as appropriate, and released. 80. 84 TESTING AND APPROVAL CONTAINERS, AND CLOSURES OR REJECTION 39 OF COMPONENTS, DRUG PRODUCT (a) Each lot of components, drug product containers, and closures shall be withheld from use until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit. (b) Representative samples of each shipment of each lot shall be collected for testing or examination.

B) Each manufacturer shall maintain distribution records which include or refer to the location of: (1) The name and address of the initial consignee; (2) The identification and quantity of devices shipped; (3) The date shipped; and (4) Any control number(s) used. 170 INSTALLATION (a) Each manufacturer of a device requiring installation shall establish and maintain adequate installation and inspection instructions, and, where appropriate, test procedures. Instructions and procedures shall include directions for ensuring proper installation so that the device will perform as intended after installation.

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