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2. Process analytical technology - Wikipedia

   en.wikipedia.org/wiki/Process_analytical_technology

   Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).

3. Validation (drug manufacture) - Wikipedia

   en.wikipedia.org/wiki/Validation_(drug_manufacture)

   The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide ...

4. Common Technical Document - Wikipedia

   en.wikipedia.org/wiki/Common_Technical_Document

   The Common Technical Document is divided into five modules: [4] Administrative and prescribing information; Overview and summary of modules 3 to 5; Quality (pharmaceutical documentation)

5. Chiral analysis - Wikipedia

   en.wikipedia.org/wiki/Chiral_analysis

   In pharmaceutical research and development stereochemical analytical methodology may be required to comprehend enantioselective drug action and disposition, chiral purity assessment, study stereochemical stability during formulation and production, assess dosage forms, enantiospecific bioavailability and bioequivalence investigations of chiral ...

6. Process performance qualification protocol - Wikipedia

   en.wikipedia.org/wiki/Process_Performance...

   A summation of relevant data and analysis from the protocol; An explanation of unexpected data and any other results not mandated by the protocol and its effects on production quality; Identify correlating effects and suggest changes to existing processes; Conclude if the process performance is adequately qualified to meet performance standards.

7. Investigator's brochure - Wikipedia

   en.wikipedia.org/wiki/Investigator's_brochure

   In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial.