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USFDA Guideline (Chemistry, Manufacturing, and Controls (CMC))

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


USFDA Guidances List 10-1-14




Validation of Chromatographic Methods — Reviewer’s Guidance (I)

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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