Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products
Analytical Procedures and Methods Validation for Drugs and Biologics
Changes to an Approved NDA or ANDA (Revised) (I)
Changes to an Approved NDA or ANDA Questions and Answers (I)
CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports
Comparability Protocols – Chemistry, Manufacturing, and Controls Information (I)
Container Closure Systems for Packaging Human Drugs and Biologics (I)
Environmental Assessment of Human Drug and Biological Aplication
Environmental Assessment Question and Answer
Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for
INDs for Phase 2 and 3 Studies; Chemistry, Manufacturing, and Controls Information (I)
Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products — Chemistry,
NDAs Impurities in Drug Substances (I)
Non-Penicillin Beta-Lactam Risk Assessment A CGMP Framework
Orally Disintegrating Tablets (I)
PAC-ALTS Postapproval Changes – Analytical Testing Laboratory Sites (I)
Residual Solvents in Drug Products Marketed in the United States
Scale-Up and Post-Approval Changes Manufacturing Equipment Addendum
Submitting Documentation for the Manufacturing of and Controls for Drug Products (I)
Submitting Samples and Analytical Data for Methods Validation (I)
SUPAC Manufacturing Equipment Addendum
SUPAC MR Modified Release Solid Oral Dosage Forms Scale Up and Postapproval Changes
SUPAC-IR and MR Immediate Release and Modified Release Solid Oral Dosage Forms
SUPAC-IR Immediate-Release Solid Oral Dosage Forms Scale-Up and Post-Approval
SUPAC-MR Modified Release Solid Oral dosage from
SUPAC-SS – Nonsterile Semisolid Dosage Forms; Scale-Up and Postapproval Changes
VALIDATION OF ANALYTICAL PROCEDURES and Methodology
Validation of Chromatographic Methods — Reviewer’s Guidance (I)
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