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 rules, EC and IPEC directions, and ISO/BSI criteria referenced within the checklists supplied in quantity I. content material: publication disguise; name; Copyright; Contents; half II digital Records/Electronic Signatures; half 803 scientific equipment Reporting; half 806 clinical units; reviews of Corrections and Removals; half 821 clinical equipment monitoring specifications; half 820 caliber method legislation; half 211 present solid production perform for accomplished Pharamaceuticals; counsel for undefined* Q7A Giid production perform suggestions for lively Pharmaceutical constituents; half 1301 Registration of brands, vendors and Dispensers of managed elements; army Specification. ordinary perform for proven Reliability and excessive Reliability certified items checklist (QPL) structures For electric, digital, and different Optic elements SpecificationsThe principles Governing Medicinal items within the eu Union; caliber Managemnet and caliber insurance Standards--Part three; caliber Systems--Models for caliber insurance in layout, improvement, creation, deploy and Servicing; caliber administration Systems--Requirements; Qualit. summary: quantity 2 of this set includes the entire textual content of the FDA rules, EC and IPEC guidance, and ISO/BSI criteria referenced within the checklists supplied in quantity I

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Extra resources for GMP/ISO Quality Audit Manual for Healthcare Manufacturers : Regulations, Standards, and Guidelines

Example text

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) 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.

40 31 32 GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers Subpart F — Production and Process Controls................................................................................ 100 Written Procedures; Deviations..................................................................... 101 Charge-in of Components ............................................................................. 103 Calculation of Yield.......................................................................................

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