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USFDA GUIDELINES(Current Good Manufacturing Practices/Compliance)

Current Good Manufacturing Practice for Phase 1 Investigational Drugs (I)


Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production (I)


Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography


PET Drugs — Current Good Manufacturing Practice (CGMP)


Pharmaceutical Components at Risk for Melamine Contamination (I)


Process Analytical Technology — A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance (I)


Process Validation: General Principles and Practices


Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (I)


Sterile Drug Products Produced by Aseptic Processing (I)


The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Good Manufacturing Practice (CGMP) (I)


Current Good Manufacturing Practices for Combination Products (I) (Draft)


Current Good Manufacturing Practices for Medical Gases (3rd Revision) (I) (Draft)


Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide (Draft)


Manufacturing, Processing or Holding of Active Pharmaceutical Ingredients (I) (Draft)


Powder Blends and Finished Dosage Units–Stratified In-Process Dosage Unit Sampling and Assessment (I) (Draft)








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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