 | 1981 - 1252 pages
...detail to permit evaluation of the adequacy of the described methods of manufacture, processing, and packing and the described facilities and controls...and professional personnel who are responsible for assuring that the drug has the safety, identity, strength, quality, and purity it purports or is represented... | |
 | 1978 - 860 pages
...facilities and controls to determine and preserve the identity, strength, quality, and purity of the drur¿ a. A description of the physical facilities including...and professional personnel who are responsible for assuring that the drug has the safety, identity, strength, quality, and purity it purports or is represented... | |
 | 1996 - 618 pages
...made without prior approval by the Food and Drug Administration, unless permitted under §514.8. (ii) A description of the qualifications, including educational...and professional personnel who are responsible for assuring that the new animal drug has the identity, strength, quality, and purity it purports or is... | |
 | 1992 - 744 pages
...and purity it purports or is represented to possess, and a statement of their responsibilities. (ill) A description of the physical facilities including...packaging, labeling, storage, and control operations. (iv) The methods used in the synthesis, extraction, isolation, or purification of any new animal drug.... | |
 | 1995 - 1360 pages
...and purity it purports or is represented to possess, and a statement of their responsibilities. (ili) A description of the physical facilities including...packaging, labeling, storage, and control operations. (iv) The methods used in the synthesis, extraction, isolation, or purification of any new animal drug.... | |
 | 1989 - 764 pages
...detail to permit evaluation of the adequacy of the described methods of manufacture, processing, and packing, and the described facilities and controls...the identity, strength, quality, and purity of the new animal drug, and the following: (i) If the applicant does not himself perform all the manufacturing,... | |
 | 1977 - 568 pages
...and purity it purports or is represented to possess, and a statement of their responsibilities. (iii) A description of the physical facilities including...processing, packaging, labeling, storage, and control ooerations. (iv) The methods used in the synthesis, extraction, isolation, or purification of any new... | |
 | 1989 - 760 pages
...detail to permit evaluation of the adequacy of the described methods of manufacture, processing, and packing, and the described facilities and controls...the identity, strength, quality, and purity of the new animal drug, and the following: (i) If the applicant does not himself perform all the manufacturing,... | |
 | 1980 - 684 pages
...permit evaluation of the adequacy of the described methods of manufacture, processing, anu rucking, and the described facilities and controls to determine...the identity, strength, quality, and purity of the new animal drug, and the following: (i) If the applicant does not himself perform all the manufacturing,... | |
 | 1963 - 1124 pages
...sufficient detail to permit evaluation of the adequacy of the manufacturing, processing, and packing methods to determine and preserve the Identity, strength, quality, and purity of the drug: (I) The methods used In the synthesis, extraction. Isolation, or purification of any new-drug susbtance.... | |
| |
... in sufficient detail to permit evaluation of the adequacy of the described methods of manufacture, processing, and packing and the described facilities and controls to determine and preserve the identity, strength, quality, and purity of the drug:... 
