GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines): Regulations, Standards, and Guidelines

Pirmais vāks
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

No grāmatas satura

Lietotāju komentāri - Rakstīt atsauksmi

Ierastajās vietās neesam atraduši nevienu atsauksmi.

Atlasītās lappuses

Saturs

MILSTD790F
201
Good Manufacturing Practices Medicinal Products for Human and Veterinary Use
221
Quality Management and Quality Assurance Standare Part 3
279
INTERNATIONAL STANDARD ISO 9001
315
INTERNATIONAL STANDARD ISO 9001
331
Quality Systems Medical Devices Particular Requirements for the Application of ISO 9001
359
Quality Systems Medical Devices Particular Requirements for the Application of ISO 9002
371
General Requirements for the Competence of Testing and Calibration Laboratories
383

Part 1303 Quotas
139
Part 1304 Records and Reports of Registrants
149
Part 1305 Order Forms
165
Part 1306 Prescriptions
173
Part 1307 Miscellaneous
185
MILQ9858A
189
1994 and ISO 90021994
412
Annex B Informative Guidelines for Establishing Applications for Specific Fields
414
INTERNATIONAL STANDARD ISO 19011
417
IPEC GMP for Bulk Excipients
447
Autortiesības

Citi izdevumi - Skatīt visu

Bieži izmantoti vārdi un frāzes

Populāri fragmenti

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.

Bibliogrāfiskā informācija