Ctd Module 3

Only available on StudyMode
  • Topic: Packaging and labeling, Gelatin, Unit load
  • Pages : 110 (25905 words )
  • Download(s) : 641
  • Published : April 24, 2012
Open Document
Text Preview
COMMON TECHNICAL DOCUMENT

CEFTEN
(CEFTIBUTEN CAPSULES 400 MG)

MODULE 3

QUALITY

3.1 MODULE 3 TABLE OF CONTENT

Sr. No.| Contents| Page No.|
3.1| MODULE 3 TABLE OF CONTENT| 2|
3.2| BODY OF DATA| 4|
3.2.S| Drug Substance | 4|
3.2.P| Drug Product| 5|
3.2.P.1| Description and Composition of the Drug Product| 5| 3.2.P.2| Pharmaceutical Development| 6|
3.2.P.2.1| Components of the Drug Product| 8|
3.2.P.2.1.1| Drug Substance | 8|
3.2.P.2.1.2| Excipients| 10|
3.2.P.2.2| Drug Product| 11|
3.2.P.2.2.1| Formulation Development| 11|
3.2.P.2.2.2| Overages| 13|
3.2.P.2.2.3| Physicochemical and Biological Properties| 14| 3.2.P.2.3| Manufacturing Process Development| 16|
3.2.P.2.4| Container Closure System| 18|
3.2.P.2.5| Microbiological Attributes| 19|
3.2.P.2.6| Compatibility| 20|
3.2.P.3| Manufacture| 21|
3.2.P.3.1| Manufacturer(s)| 21|
3.2.P.3.2| Batch Formula| 23|
3.2.P.3.3| Description of Manufacturing Process and Process Controls| 24| 3.2.P.3.4| Controls of Critical Steps and Intermediates| 29| 3.2.P.3.5| Process Validation and/or Evaluation| 30|

3.2.P.4| Control of Excipients| 42|
3.2.P.4.1| Specifications| 43|
3.2.P.4.2| Analytical Procedures| 51|
3.2.P.4.3| Validation of Analytical Procedures| 68|
3.2.P.4.4| Justification of Specifications| 69|
3.2.P.4.5| Excipients of Human or Animal Origin| 70|
3.2.P.4.6| Novel Excipients| 71|
3.2.P.5| Control of Drug Product| 72|
3.2.P.5.1| Specification(s)| 72|
3.2.P.5.2| Analytical Procedures| 73|
3.2.P.5.3| Validation of Analytical Procedures| 77|
3.2.P.5.4| Batch Analyses| 89|
3.2.P.5.5| Characterization of Impurities| 96|
3.2.P.5.6| Justification of Specification(s)| 98|
3.2.P.6| Reference Standards or Materials| 100|
3.2.P.7| Container Closure System| 105|
3.2.P.8| Stability| 112|
3.2.P.8.1| Stability Summary and Conclusion | 112|
3.2.P.8.2| Post-approval Stability Protocol and Stability Commitment | 115| 3.2.P.8.3| Stability Data | 116|
3.3| LITERATURE REFERENCES| 129|

3.2 BODY OF DATA

3.2.S DRUG SUBSTANCE

For “BODY OF DATA” of “DRUG SUBSTANCE” “CEFTIBUTEN DIHYDRATE” refer “ANNEXURE-I” (Drug Master File).

3.2.P DRUG PRODUCT CEFTEN (CEFTIBUTEN CAPSULES 400 MG)

3.2.P.1 DESCRIPTION AND COMPOSITION OF THE DRUG PRODUCT CEFTEN (CEFTIBUTEN CAPSULES 400 MG)

Description: A white, opaque (cap & body), size ‘0’ unprinted hard gelatin capsules containing white to off white powder.

Composition: Each capsule contains:
Ceftibuten Dihydrate equivalent to Ceftibuten ………. 400 mg Excipients: Q.S.

Composition of each capsule is as per follows:

Sr. No.| Ingredient| Quantity / Capsule| Overages| Use| 1.| *Ceftibuten Dihydrate IH| 435.20 mg| Nil| Active|
2.| Magnesium Stearate BP| 15.00 mg| Nil| Lubricant|
3.| Lactose Anhydrous BP| 99.80 mg| Nil| Diluent|
4.| Purified Talc BP| 30.00 mg| Nil| Lubricant|
5.| White opaque (cap & body), size ‘0’, unprinted, empty hard gelatin capsule shell| 01 No.| Nil| Container for incorporation of drugs|

*1.088 mg of Ceftibuten Dihydrate equivalent to 1.0 mg of Ceftibuten.

3.2.P.2 PHARMACEUTICAL DEVELOPMENT OF CEFTEN (CEFTIBUTEN CAPSULES 400 MG)

Vendors are identified and the samples were analyzed from three different vendors as per the specification. All the packing materials were sourced from certified vendors and duly tests for integrity. Active raw material was tested as per specification and the stability and spectral studies including Elemental Analysis, IR, NMR, UV etc. were performed.

The formulation development was done by using different excipients and different manufacturing techniques. Different manufacturing techniques were used. The critical process parameters of the manufacturing method were...
tracking img