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1、G:5831dft.doc 10/27/03 Guidance for Industry Powder Blends and Finished Dosage Units Stratified In-Process Dosage Unit Sampling and Assessment DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submit
2、ted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with th
3、e docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document contact Jon E. Clark, 301-594-5613 or Mike Gavini, 301-827-9053. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluati
4、on and Research (CDER) October 2003 Pharmaceutical CGMPs G:5831dft.doc 10/27/03 Guidance for Industry Powder Blends and Finished Dosage Units Stratified In-Process Dosage Unit Sampling and Assessment Additional copies are available from: Office of Training and Communication Division of Drug Informat
5、ion, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 http:/www.fda.gov/cder/guidance/index.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER
6、) Office of Pharmaceutical Science (OPS) Office of Compliance (OC) October 2003 Pharmaceutical CGMPs Contains Nonbinding Recommendations Draft Not for Implementation G:5831dft.doc 10/27/03 TABLE OF CONTENTS I.INTRODUCTION. 1 II.BACKGROUND. 1 III. SCOPE. 2 IV. CORRELATION OF IN-PROCESS STRATIFIED SAM
7、PLING WITH POWDER MIX AND FINISHED PRODUCT 4 A.Assessment of Powder Mix Uniformity4 B.Correlation of Powder Mix Uniformity with Stratified In-Process Dosage Unit Data5 C.Correlation of Stratified In-Process Samples with the Finished Product.6 V.EXHIBIT/VALIDATATION BATCH POWDER MIX HOMOGENEITY. 6 VI
8、. VERIFICATION OF MANUFACTURING CRITERIA . 7 A.In-Process Dosage Unit Sampling and Analysis7 B.Criteria to Meet the Readily Pass Classification .8 C.Criteria to Meet the Marginally Pass Classification .8 D.Sample Locations for Routine Manufacturing9 VII. ROUTINE MANUFACTURING BATCH TESTING METHODS 9
9、 A.Standard Criteria Method (SCM)9 1. Stage 1 Test10 2. Stage 2 Test10 B.Marginal Criteria Method (MCM) 10 C.Switching to Standard Test Method from Marginal Test Method11 VIII.REPORTING THE USE OF STRATIFIED SAMPLING 11 A.Applications Not Yet Approved11 B.Postapproval Change.12 GLOSSARY. 13 ATTACHME
10、NT 1: VERIFICATION OF MANUFACTURING CRITERIA 14 ATTACHMENT 2: ROUTINE MANUFACTURING BATCH TESTING 15 Contains Nonbinding Recommendations Draft Not for Implementation G:5831dft.doc 10/27/03 1 Guidance for Industry11 2 Powder Blends and Finished Dosage Units Stratified In-Process3 Dosage Unit Sampling
11、 and Assessment4 5 6 This draft guidance, when finalized, will represent the Food and Drug Administrations (FDAs) current7 thinking on this topic. It does not create or confer any rights for or on any person and does not operate to8 bind FDA or the public. You can use an alternative approach if the
12、approach satisfies the requirements of9 the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA10 staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call11 the appropriate number listed on the title pag
13、e of this guidance. 12 .13 14 15 I.INTRODUCTION 16 17 This guidance is intended to assist manufacturers of human drug products in meeting the18 requirements of 21 CFR 211.110 for demonstrating the adequacy of mixing to ensure uniformity19 of in-process powder blends and finished dosage units. This g
14、uidance describes the procedures20 for assessing powder mix adequacy, correlating in-process dosage unit test results with powder21 mix test results, and establishing the initial criteria for control procedures used in routine22 manufacturing.23 24 FDAs guidance documents, including this guidance, d
15、o not establish legally enforceable25 responsibilities. Instead, guidances describe the Agencys current thinking on a topic and should26 be viewed only as recommendations, unless specific regulatory or statutory requirements are27 cited. The use of the word should in Agency guidances means that some
16、thing is suggested or28 recommended, but not required. 29 30 31 II.BACKGROUND32 33 This guidance is the result of an Agency effort to achieve a science-based policy and regulatory34 enforcement. Experts from industry, academia, and the FDA developed the principles35 underlying this guidance after extensive public discussion. A brief history of the evolution of36 this guidance is provided in the following paragraphs.37 1 This guidance has been prepared by the Office of Pharmace
