GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines): Regulations, Standards, and Guidelines
CRC Press, 2004. gada 30. dec. - 452 lappuses
This well-known QA manual has been updated to provide the guidance readers need to assess their compliance with standard regulations. This Volume 2 of a three-part package contains the full text on: * FDA regulations* EC and IPEC guidelines* ISO/BSI standards referenced in the checklists furnished in volume 1Easy-to-read and organized to provide fa
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Part 1301 Registration of Manufacturers Distributors and Dispensers of Controlled Substances
Part 1302 Labeling and Packaging Requirements for Controlled Substances
Good Manufacturing Practices Medicinal Products for Human and Veterinary Use
Quality Management and Quality Assurance Standare Part 3
INTERNATIONAL STANDARD ISO 9001
INTERNATIONAL STANDARD ISO 9001
Quality Systems Medical Devices Particular Requirements for the Application of ISO 9001
Quality Systems Medical Devices Particular Requirements for the Application of ISO 9002
General Requirements for the Competence of Testing and Calibration Laboratories
Part 1303 Quotas
Part 1304 Records and Reports of Registrants
Part 1305 Order Forms
Part 1306 Prescriptions
Part 1307 Miscellaneous
1994 and ISO 90021994
Annex B Informative Guidelines for Establishing Applications for Specific Fields
INTERNATIONAL STANDARD ISO 19011
IPEC GMP for Bulk Excipients
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GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their ...
Priekšskatījums nav pieejams - 2004
acceptance accordance action activities additional Administrator analysis and/or application appropriate approved areas assurance audit authorized batch calibration carried changes chapter cleaning complete components conducted conformance containers contract controlled substances corrective criteria defined described determine dispensed distribution documented drug product effective electronic ensure equipment established evaluation facilities given guidance handling hearing identified implementation import individual inspection instructions intended intermediate International Standard issued labeling laboratory limits listed maintain maintenance management system manufacturer materials measurement medical devices meet methods monitoring necessary nonconforming NOTE objectives operations organization packaging performed person personnel practice prepared prescription prevent procedures purchased pursuant quality system quantity records reference registration release requirements responsibility sampling Schedule Section specifications storage suitable supplier taken technical units validation verify written
117. lappuse - Such amounts of any controlled substance listed in Schedule I or II as the Administrator shall find to be necessary to provide for the medical, scientific, or other legitimate needs of the United States in any case in which the Administrator finds that competition among domestic manufacturers of the controlled substance is inadequate and will not be rendered adequate by the registration of additional manufacturers under section 303 of the Act (21 USC 823); or (iv) Such limited quantities of any controlled...
140. lappuse - II to be manufactured each calendar year to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks.
174. lappuse - The prescriptions may be prepared by the secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. A corresponding liability rests upon the pharmacist who fills a prescription not prepared in the form prescribed by these regulations.
183. lappuse - Act, the date of the sale, the name and address of the purchaser, the name and quantity of the article sold...
162. lappuse - ... container a stock record card on which shall be kept a complete record of all withdrawals therefrom.
115. lappuse - ... practitioner requesting registration, as well as the merits of the research protocol. The Secretary, in determining the merits of each research protocol, shall consult with the Attorney General as to effective procedures to adequately safeguard against diversion of such controlled substances from legitimate medical or scientific use.
167. lappuse - CD, of &.C., my true and lawful attorney, for me, and in my name, place, and stead, to...
57. lappuse - The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use...
39. lappuse - In lieu of §211.100 such testing by the manufacturer, a certificate of testing may be accepted from the supplier, provided that at least a visual identification Is conducted on such containers/closures by the manufacturer and provided that the manufacturer establishes the reliability of the supplier's test...
119. lappuse - General may, in his discretion, suspend any registration simultaneously with the institution of proceedings under this section, in cases where he finds that there is an imminent danger to the public health or safety.