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"If an experiment does not hold out the possibility of causing one to revise one's views, it is hard to see why it should be done at all."

-Peter Medawar
1960 Nobel Laureate

"If you don't have time to do it right, when will you have time to do it over?"

-John Wooden
Basketball Coach

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-John Wooden
Basketball Coach

"Intellectuals solve problems, geniuses prevent them."

-Albert Einstein

"Strive not to be a success, but rather to be of value."

-Albert Einstein

"The whole of science is nothing more than a refinement of everyday thinking."

-Albert Einstein

"Whoever is careless with the truth in small matters can not be trusted with important matters."

-Albert Einstein

"I start where the last man left off."

-Thomas A. Edison

"Hard work doesn't guarantee success, but improves its chances."

-Thomas A. Edison

"Success is dependent on effort"

-Sophocles (496-406)

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-Thomas A. Edison

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-Thomas A. Edison

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"He who asks a question is a fool for five minutes; he who does not ask a question remains a fool forever."

-Chinese Proverb

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"Nobody is right all the time and even a broken clock is right two times a day."

-Bill Clinton on need to work together to solve problems DNC 2012

"Good science doesn't happen when people are keeping their heads down.  You need a raucous, rowdy discussion"

- Anonymous

"The great tragedy of Science is the slaying of a beautiful hypothesis by an ugly fact."

Thomas H. Huxley, "Biogenesis and Abiogenisis"

"Many consultants can 'turn the crank' but only few know 'when to crank, which crank to turn, which direction to crank, or how many turns."

- Anonymous

"Success is the ability to move from failure to failure with no loss of enthusiasm."

Winston Churchill

 

 

 

 

 

The following is a list of all eCTD template sections for Drug Substance and Drug Product (Module 3 Quality).  General content information is provided in each section as guide along with references to relevant ICH guidance's.  For Phase 1-3 specific required content see CMC Phase 1-3 Guidances.

3.2.S. Drug Substance

3.2.S.1.1 GENERAL INFORMATION (Nomenclature)

3.2.S.1.2 GENERAL INFORMATION (Structure)

3.2.S.1.3 GENERAL INFORMATION (General Properties)

3.2.S.2.1 MANUFACTURE (Manufacturers)

3.2.S.2.2 MANUFACTURE (Description of Manufacturing and Manufacturing Controls)

3.2.S.2.3 MANUFACTURE (Control of Materials)

3.2.S.2.4 MANUFACTURE (Control of Critical Steps and Intermediates)

3.2.S.2.5 MANUFACTURE (Process Validation and-or Evaluation)

3.2.S.3.1 CHARACTERIZATION (Elucidation of Structure and other Characteristics)

3.2.S.3.2 CHARACTERIZATION (Impurities)

3.2.S.4.1 CONTROL OF DRUG SUBSTANCE (Specifications)

3.2.S.4.2 CONTROL OF DRUG SUBSTANCE (Analytical Procedures)

3.2.S.4.3 CONTROL OF DRUG SUBSTANCE (Validation of Analytical Procedures)

3.2.S.4.4 CONTROL OF DRUG SUBSTANCE (Batch Analyses)

3.2.S.4.5 CONTROL OF DRUG SUBSTANCE (Justification of Specification)

3.2.S.5 REFERENCE STANDARDS

3.2.S.6 CONTAINER CLOSURE

3.2.S.7.1 STABILITY (Summary and Conclusions)

3.2.S.7.2 STABILITY (Post Approval Stability Protocol and Stability Commitment)

3.2.S.7.3 STABILITY (Stability Data)

3.2.P. Drug Product 

3.2.P.1 DESCRIPTION AND COMPOSITION OF DRUG PRODUCT

3.2.P.2.1 COMPONENTS OF THE DRUG PRODUCT (Drug Substance, Excipients)

3.2.P.2.2 DRUG PRODUCT (Formulation Development, Overages, Physiochemical and Biological Properties)

3.2.P.2.3 MANUFACTURING PROCESS DEVELOPMENT

3.2.P.2.4 CONTAINER CLOSURE SYSTEM

3.2.P.2.5 MICROBIOLOGICAL ATTRIBUTES

3.2.P.2.6 COMPATIBILITY

3.2.P.3.1 MANUFACTURERS

3.2.P.3.2 BATCH FORMULA

3.2.P.3.3 DESCRIPTION OF MANUFACTURING PROCESS AND PROCESS CONTROLS

3.2.P.3.4 CONTROLS OF CRITICAL STEPS AND INTERMEDIATES

3.2.P.3.5 PROCESS VALIDATION AND-OR EVALUATION

3.2.P.4.1 CONTROL OF EXCIPIENTS (Specifications)

3.2.P.4.2 CONTROL OF EXCIPIENTS (Analytical Procedures)

3.2.P.4.3 CONTROL OF EXCIPIENTS (Validation of Analytical Procedures)

3.2.P.4.4 CONTROL OF EXCIPIENTS (Justification of Specifications)

3.2.P.4.5 CONTROL OF EXCIPIENTS (Excipients of Human or Animal Origin)

3.2.P.4.6 CONTROL OF EXCIPIENTS (Novel Excipients)

3.2.P.5.1 SPECIFICATIONS

3.2.P.5.2 ANALYTICAL PROCEDURES

3.2.P.5.3 VALIDATION OF ANALYTICAL PROCEDURES

3.2.P.5.4 BATCH ANALYSES

3.2.P.5.5 CHARACTERIZATION OF IMPURITIES

3.2.P.5.6 JUSTIFICATION OF SPECIFICATIONS

3.2.P.6 REFERENCE STANDARDS OR MATERIALS

3.2.P.7 CONTAINER CLOSURE

3.2.P.8.1 STABILITY SUMMARY AND CONCLUSIONS

3.2.P.8.2 POSTAPPROVAL STABILITY PROTOCOL AND STABILITY COMMITMENT

3.2.P.8.3 STABILITY DATA

 

3.2.A Appendices 

3.2.A.1 FACILITIES AND EQUIPMENT

3.2.A.2 ADVENTITIOUS AGENTS SAFETY EVALUATION

3.2.A.3 NOVEL EXCIPIENTS

 

3.2.R Regional  

3.2.R.1 REGIONAL INFORMATION

3.2.R.2 METHODS VALIDATION PACKAGE

 

2.3 Example Quality Overall Summery 

Example MK Overall Quality Summery

 

 

 

 
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