Summary of Requirements for New Drug Submission - Trinidad ...
Summary of Requirements for New Drug Submission - Trinidad ...
Summary of Requirements for New Drug Submission - Trinidad ...
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(C)<br />
Pharmacotherapeutic data<br />
Therapeutic uses<br />
Clinical trials<br />
Therapeutic equivalence<br />
(D)<br />
Toxicity data<br />
All types<br />
N.B. Data: - Published and In-house.<br />
(4) Manufacturing Details<br />
Manufacturinglunit Composition Formula<br />
Brief Manufacturing DirectionlProcedure<br />
Brief Manufacturing Controls<br />
Sampling and Testing Procedures<br />
GMP Certificate<br />
(5) Packaqing Materials (Containers and Closures)<br />
(6) Ink and Printing<br />
(7) Package Insert<br />
Description<br />
Composition<br />
Size and dimension requirements (guage, thickness, etc.)<br />
with target value and acceptable tolerances<br />
Colour<br />
Processes necessary to make the article acceptable<br />
to pharmaceutical production (e.g, coating, washing,<br />
sterility <strong>of</strong> surfaces, etc.)<br />
Samples<br />
Colour<strong>of</strong>lnk<br />
Chemical Composition <strong>of</strong> Ink<br />
Description <strong>of</strong> Ink (colourfast, light resistant, rub<br />
resistant, reflectance, etc.)<br />
Other characteristics <strong>of</strong> Ink (odour, distribution, etc.)<br />
Printing - capacity to smear, smudge, sc<strong>of</strong>f or be<br />
removed during normal handling <strong>of</strong> the package<br />
Where applicable (Prescription <strong>Drug</strong>s)<br />
Standard <strong>Requirements</strong>
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