REGULASI US FDA


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21 CFR PART 210 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING PROCESSING, PACKAGING, OR HOLDING OF DRUGS: GENERAL
21 CFR PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
– (2016) Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry
– (2015) Analytical Procedures and Methods Validation for Drugs and  biologics
– (2015) Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules

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