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Handbook of p vol 2 uncompressed solid products

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Handbook of p vol 2 uncompressed solid products

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... of the supplier’s test results through appropriate validation of the supplier’s test results at appropriate intervals When appropriate, components shall be microscopically examined Each lot of. .. Targeted-Release Capsules Procarbazine Hydrochloride Capsules Prochlorperazine Sustained-Release Capsules Propoxyphene Hydrochloride, Caffeine, and Aspirin Capsules Propoxyphene Hydrochloride Capsules Propranolol... Itraconazole Capsules Ketoprofen and Misoprostol Capsules © 20 04 by CRC Press LLC Ketoprofen Capsules Lansoprazole Capsules Lansoprazole Delayed-Release Capsules Lincomycin Capsules Linezolid Oral Suspension

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Xem thêm: Handbook of p vol 2 uncompressed solid products , Chapter 1. Global Good Manufacturing Practices Compliance, G. PACKAGING AND LABELING CONTROLS, Chapter 2. Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections, XVIII. CLINICAL TEST SUPPLIES AND PLACEBOS, Amoxicillin and Clavulanic Acid Powder for Suspension, 125 mg and 31.25 mg per 5 ml

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  • 1747_fm

    • Handbook of Pharmaceutical Manufacturing Formulations: Uncompressed Solid Products

      • Dedication

      • Preface to the Series

      • Preface to the Volume

      • About the Author

      • Table of Contents

      • 1747_C01

        • Handbook of Pharmaceutical Manufacturing Formulations: Uncompressed Solid Products

          • Part I. Regulatory and Manufacturing Guidelines

            • Contents

            • Chapter 1. Global Good Manufacturing Practices Compliance

              • I. INTRODUCTION

                • A. GENERAL PROVISIONS

                • B. ORGANIZATION AND PERSONNEL

                • C. BUILDINGS AND FACILITIES

                • D. E QUIPMENT

                • E. CONTROL OF COMPONENTS AND DRUG PRODUCT CONTAINERS AND CLOSURES

                • F. PRODUCTION AND PROCESS CONTROLS

                • G. PACKAGING AND LABELING CONTROLS

                • H. HOLDING AND DISTRIBUTION

                • I. LABORATORY CONTROLS

                • J. RECORDS AND REPORTS

                • K. RETURNED AND SALVAGED DRUG PRODUCTS

                • 1747_C02

                  • Handbook of Pharmaceutical Manufacturing Formulations: Uncompressed Solid Products

                    • Table of Contents

                    • Chapter 2. Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections

                      • I. BACKGROUND

                      • II. IMPLEMENTATION

                        • A. OBJECTIVES

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