CDJ,
The Link works. Incase you are unable to access, here is the information from the thread posted
Mr.A. Tingley. Thanks to his very detailed response. I hope he will approve reposting his response for the benefit of Cove users.
ASQ CPGP BOK References
Code of Federal Regulations 21CFR (including FDA Preamble [Fed Register Vol. 43 No. 190] ) documents
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm090016.htm
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm
• 210-211 Current Good Manufacturing Practice in Manufacture, Processing, Packing, or Holding Finished Pharmaceuticals
•
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=210
•
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=211
http://www.access.gpo.gov/nara/cfr/waisidx_03/21cfr210_03.html
http://www.access.gpo.gov/nara/cfr/waisidx_03/21cfr211_03.html
http://www.fda.gov/AboutFDA/CentersOffices/cder/ucm095412.htm
• Section 7 Recalls (Including Product Corrections)
•
http://www.accessdata.fda.gov/scrip...CFRPart=7&showFR=1&subpartNode=21:1.0.1.1.5.3
• Part 11 Electronic Records ; electronic signatures
•
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=11&showFR=1
• Part 58 Good Laboratory Practices for Non-clinical Laboratory Studies
•
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=58&showFR=1
• 1308.11-1308.15 requirement for storage of controlled substances
•
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=1308&showFR=1
• 205 Guidelines for State Licensing of Wholesale Prescription Drug Distributors
•
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=205&showFR=1
Food and Drug Administration (FDA) Guidances
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064971.htm
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/default.htm
• Changes to an Approved NDA or ANDA
•
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm077097.pdf
•
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070544.pdf
• Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
•
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM146076.pdf
• Container Closure Systems for Packaging Human Drugs and Biologics
•
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070551.pdf
• Current Good Manufacturing Practice for Combination Products
•
http://www.fda.gov/RegulatoryInformation/Guidances/ucm126198.htm
•
http://www.fda.gov/RegulatoryInformation/Guidances/ucm122047.htm
•
http://edocket.access.gpo.gov/2009/pdf/E9-22850.pdf
•
http://www.fda.gov/CombinationProducts/default.htm
• for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products
•
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072171.pdf
• General Principles of Software Validation
•
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126955.pdf
• Powder Blends and Finished Dosage Units--Stratified In-Process Dosage Unit Sampling and Assessment
•
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070314.pdf
• Product Recalls, Including Removals and Corrections
•
http://www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm
•
http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm
•
http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm
•
http://www.accessdata.fda.gov/scrip...CFRPart=7&showFR=1&subpartNode=21:1.0.1.1.5.3
• Q1A (R2) Stability Testing of New Drug Substances and Products
•
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128204.pdf
• Q1E Evaluation of Stability Data
•
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128122.pdf
• Q3B( R) Impurities in New Drug Products
•
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073389.pdf
• Quality Systems Approach to Pharmaceutical CGMP Regulations
•
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070337.pdf
• Sterile Drug Products Produced by Aseptic Processing
•
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070342.pdf
FDA Guide to Inspections
http://www.fda.gov/Cosmetics/Guidan...eGMPGuidelinesInspectionChecklist/default.htm
Inspection Checklist
http://www.fda.gov/downloads/Drugs/NewsEvents/UCM167322.pdf
Presentation: Conducting The FDA Inspection
http://www.fda.gov/ICECI/Inspections/InspectionGuides/default.htm
• Investigations Operations Manual (IOM) 2008
•
http://www.fda.gov/ICECI/Inspections/IOM/default.htm
• Microbiological Pharmaceutical Quality Control Laboratories
•
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074914.htm
• Pharmaceutical Quality Control Laboratories
•
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074918.htm
• Topical Drug Products
•
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074933.htm
• Validation of Cleaning Processes
•
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074922.htm
• High Purity Water Systems
•
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074905.htm
• Biotechnology inspection guide reference materials and training aids
•
http://www.fda.gov/ICECI/Inspections/InspectionGuides/UCM074181.htm
http://www.fda.gov/ICECI/Inspections/InspectionGuides/InspectionTechnicalGuides/default.htm
Inspection Technical Guides
FDA Guidelines
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/default.htm
• Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs
•
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071597.pdf
• Validation of the Limulus Amebocyte Lysate Test
•
http://www.fda.gov/downloads/Biolog...toryInformation/Guidances/Blood/UCM080966.pdf
• Inspections of Sterile Drug Substance Manufacturers
•
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074930.htm
• Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development and Validation
•
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074928.htm
• Investigating Out of Specification Test Results
•
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm090016.htm
• Above leads to a central page which deadends
•
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070287.pdf
• General Principles of Process Validation
•
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070336.pdf
•
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124720.htm
FDA Policy Guides (Compliance Policy Guides (CPG))
http://www.fda.gov/ICECI/ComplianceManuals/ComplianceProgramManual/default.htm
• Preapproval Inspections 7346.832
•
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm095503.htm
•
http://www.fda.gov/downloads/Drugs/...ufacturingPracticescGMPforDrugs/UCM071871.pdf
• Sterile Drug Process Inspections Program 7356.002A
•
http://www.fda.gov/downloads/ICECI/ComplianceManuals/ComplianceProgramManual/ucm125422.pdf
• Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections Program 7356.002
•
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm095598.htm
• Compliance Program Guidance Manual 7356.002F Active Pharmaceutical Ingredient (API) Process Inspection
•
http://www.fda.gov/downloads/ICECI/ComplianceManuals/ComplianceProgramManual/ucm125420.pdf
Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S)
http://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2004/picsqs.aspx
http://www.21cfrpart11.com/files/library/reg_guid_docs/pics_guid.pdf
http://www.picscheme.org/
• PE 008-2 Explanatory Notes for Industry on the Preparation of a Site Master File
•
http://www.picscheme.org/publication.php?id=15
• PE 010-3 PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments
•
http://www.picscheme.org/publication.php?id=8
• Pl 006-3 Recommendations on Validation Master Plan Installation and Operational Qualification Non-Sterile Process Validation Cleaning Validation
•
http://www.picscheme.org/publication.php?id=8
• Pl 007-4 Recommendation on the Validation of Aseptic Processes
•
http://www.picscheme.org/publication.php?id=8
• Pl 009-3 Aide-Memoire on Inspection of Utilities
•
http://www.picscheme.org/publication.php?id=14
• Pl 010-3 Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects
•
http://www.picscheme.org/publication.php?id=17
• Pl 011-3 Good Practices for computerized systems in regulated “GXP” environments
•
http://www.picscheme.org/publication.php?id=8
• Pl 012-3 Recommendation on Sterility Testing
•
http://www.picscheme.org/publication.php?id=8
• Pl 014-3 Recommendation on Isolators Used for Aseptic Processing and Sterility Testing
•
http://www.picscheme.org/publication.php?id=8
American National Standards Institute (ANSI)/International Organization for Standards (ISO)
• ANSI/ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories
•
http://www.hartscientific.com/publications/17025.htm
• ISO 19011:2002 Guidelines for Quality and Environmental Management Systems Auditing
• ISO 19011:2002 provides guidance on the principles of auditing, managing audit programmes, conducting quality management system audits and environmental management system audits, as well as guidance on the competence of quality and environmental management system auditors.
It is applicable to all organizations needing to conduct internal or external audits of quality and/or environmental management systems or to manage an audit programme.
The application of ISO 19011 to other types of audits is possible in principle provided that special consideration is paid to identifying the competence needed by the audit team members in such cases.
•
http://staratel.com/iso/ISO19011/Doc/ISO190112002/ISO19011_eng.pdf
•
http://www.iso.org/iso/catalogue_detail?csnumber=31169
• ISO 9001-2000 Quality Management Systems Requirements
•
http://www.ksc.nasa.gov/procurement/kics/docs/iso9001.pdf
ISO 9001:2000 specifies requirements for a quality management system where an organization
1. needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and
2. aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.
•
http://www.iso.org/iso/catalogue_detail?csnumber=21823
Directives
http://ec.europa.eu/enterprise/sectors/pharmaceuticals/human-use/package_en.htm
• Directive 2001/82/EC on the Community Code Relating to Veterinary Medicinal Products
•
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-5/dir_2004_28/dir_2004_28_en.pdf
•
http://www.emea.europa.eu/htms/general/direct/legislation/background.htm
• Directive 2003/94/EC Laying Down the Principles and Guidelines of Good Manufacturing Practice in Respect of Medicinal Products for Human and Investigational Medicinal Products for Human Use as amended
•
• Directive 2001/83/EC on the Community Code Relating to human medicinal products
•
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/dir_2001_83/dir_2001_83_en.pdf
European Good Manufacturing Practice
http://ec.europa.eu/enterprise/sect.../quality/manufacturing-practices/index_en.htm
http://www.emea.europa.eu/
• Eudralex Volume 4, Parts I and II and Annexes
•
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol4_en.htm
•
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf
Health Canada Guidelines
• 0069 Guidelines for Temperature Control of Drug Products During Storage and Transportation
•
http://www.hc-sc.gc.ca/dhp-mps/comp...oducts_storage_transportation_ltr-doc-eng.php
• Good Manufacturing Practices Guidelines
•
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0001-eng.php
•
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui_23_tc-tm-eng.php
International Conference on Harmonization (ICH) Documents
http://www.ich.org/cache/compo/276-254-1.html
http://www.fda.gov/RegulatoryInformation/Guidances/ucm122049.htm
• ICH Q10 Harmonized Tripartite Guideline--Pharmaceutical Quality System
•
• ICH Q7 Good Manufacturing Guide for Active Pharmaceutical Ingredients
•
http://www.ich.org/LOB/media/MEDIA433.pdf
• ICH Q9 Quality Risk Management
•
http://www.ich.org/LOB/media/MEDIA1957.pdf
• ICH Q10 Pharmaceutical Quality System
•
http://www.ich.org/LOB/media/MEDIA3917.pdf
• ICH Q2A Text on Validation of Analytical Procedures
•
http://www.ich.org/LOB/media/MEDIA417.pdf
• ICH Q2B Validation of Analytical Procedures: Methodology
•
http://www.ich.org/LOB/media/MEDIA417.pdf
• ICH Q3A Impurities in New Drug Substances
•
http://www.ich.org/LOB/media/MEDIA422.pdf
• ICH Q3C Impurities: Guideline for Residual Solvents
•
http://www.ich.org/LOB/media/MEDIA5254.pdf
• ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
•
http://www.ich.org/LOB/media/MEDIA430.pdf
• ICH Q8 Pharmaceutical Development
•
http://www.ich.org/LOB/media/MEDIA4986.pdf
International Society for Pharmaceutical Engineering (ISPE) Guidelines
http://www.ispe.org/
• ISPE GAMP IV and V (Good Automated Manufacturing Practice) Guide for Validation of Automated Systems
•
U.S. Drug Enforcement Agency (DEA)
• 21 USC Sec. 812: L.91-513 Controlled substances act
•
http://www.fda.gov/RegulatoryInformation/Legislation/ucm148726.htm
Parenteral Drug Association (PDA) Technical Reports
• Report No. 1 Validation of Steam Sterilization Cycles
•
Japan
• Pharmaceutical Administration, Regulation and Drug Development in Japan
•
http://www.jpma.or.jp/english/isuues/practice.html
•
http://www.jpma.or.jp/english/
•
http://www.jpma.or.jp/english/parj/0903.html
European Pharmacopeia
• 2.2.44 Total Organic Carbon in Water for Pharmaceutical Use
•
• 2.2.46 Chromatographic Separation Techniques
•
• 2.6.7 Mycoplasmas
•
Australian Guidelines
TGA - safeguarding public health & safety in Australia by regulating medicines, medical devices, blood & tissues
http://www.tga.gov.au/docs/html/gmpcodau.htm
http://www.tga.gov.au/
• TGA Guidelines for Sterility Testing of Therapeutic Goods
•
http://www.tga.gov.au/docs/pdf/sterilit.pdf
• TGA Amended EU (EMEA/410/01) Guideline Note for Guidance on Minimizing the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products
•
http://www.tga.gov.au/docs/html/euguidsup.htm
•
http://www.tga.gov.au/about/about.htm
United States Pharmacopeia (USP)
• General chapters related to pharmaceutical analytical methods and practices
•
http://www.usp.org/pdf/EN/meetings/asMeetingIndia/verificationPrograms.pdf
•
http://www.usp.org/pdf/EN/eventsEducation/asMeeting/2007Tampa/presentations/track1session4.pdf
•
World Health Organization (WHO) documents
http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
• Good Manufacturing Practices (A Compendium of Guidelines and Related Materials Volume 2: Good Manufacturing Practices and Inspection)
•
http://whqlibdoc.who.int/publications/2007/9789241547161_eng.pdf
•
http://www.who.int/medicines/areas/quality_safety/quality_assurance/IntPhSkMarch2006.pdf
•
http://whqlibdoc.who.int/publications/2004/9241546190_introduction.pdf
•
http://whqlibdoc.who.int/publications/2004/9241546190.pdf
•
http://www.who.int/medicines/services/expertcommittees/pharmprep/GMP-Sterile_QAS09295.pdf
•
http://www.who.int/medicines/servic...ep/CleanRev-290709-GMPHazardous_QAS08_256.pdf
• QAS/04.068/Rev. 2 Good Distribution Practices for Pharmaceutical Products
•
http://whqlibdoc.who.int/hq/2004/a86270_glossaire.pdf
•
http://www.who.int/topics/pharmaceutical_products/en/
• Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials, 2004 WHO
•
http://www.who.int/medicines/public...nt/medicines/publications/brochure_pharma.pdf
•
http://www.who.int/medicines/services/expertcommittees/pharmprep/TermListcategory.pdf
•
http://www.who.int/medicines/areas/quality_safety/quality_assurance/IntPhSkMarch2006.pdf
•
http://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf
FDA Center for Biologics Evaluation & Research (CBER) Guidances
http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074345.pdf
• Bioanalytical Method Validation
•
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073285.pdf
•
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070107.pdf
• Biological Indicator (BI) Premarket Notification [510(k)] Submissions
•
http://www.fda.gov/downloads/Biolog...toryInformation/Guidances/Blood/ucm062955.pdf
•
http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/510kProcess/default.htm
• Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components
•
http://www.fda.gov/downloads/Biolog...ryInformation/Guidances/General/UCM163923.pdf
• Characterization and Qualification of Cell Substrates and Other Biological Starting Mat’ls Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
•
http://www.fda.gov/downloads/Biolog...yInformation/Guidances/Vaccines/ucm092122.pdf
• Points to Consider (PTC) in the Characterization of Cell Lines Used to Produce Biologicals
•
http://www.fda.gov/downloads/Biolog...RecommendationsforManufacturers/UCM062745.pdf
•
http://www.fda.gov/ohrms/dockets/ac/00/backgrd/3616b1b.pdf
• Q5A Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
•
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073454.pdf
•
http://www.fda.gov/ohrms/dockets/ac...02-FDA-Cherney _files/frame.htm#slide0125.htm
• Q5E Comparability of Biotechnological/Biological Product Subject to Changes in their Manufacturing Process
•
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128076.pdf
9CFR and 21CFR documents (related to biologics)
• 9 CFR Parts related to Animal Biologics Quality Requirements in Manufacturing
•
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128031.pdf
• 21 CFR 601 Licensing
•
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=601&showFR=1
• 21 CFR 600 Biological Products: General
•
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=600&showFR=1
• 21 CFR 610 selected sections critical to biologic drugs
•
http://www.fda.gov/BiologicsBloodVa...oblem/BiologicalProductDeviations/default.htm http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=610&showFR=1
Compliance Policy Guides (CPGs)
• CPG 7345.848 Inspection of Biological Drug Products
http://www.fda.gov/BiologicsBloodVa...es/Enforcement/CompliancePrograms/default.htm
http://www.fda.gov/BiologicsBloodVaccines/ResourcesforYou/Industry/default.htm
The Center for Biologics Evaluation and Research (CBER) has established a Manufacturers Assistance and Technical Training Branch to provide assistance and training to industry, including large and small manufacturers and trade associations, and to respond to requests for information regarding CBER policies and procedures. Manufacturers assistance is available in numerous areas including: clinical investigator information, adverse event reporting procedures, electronic submissions guidance and requirements, and information on how to submit an Investigational New Drug Application (IND) to administer an investigational product to humans.
Laws, Regulations, Guidances and Other Information
• Biologics Guidances
• Guidances
• Memoranda to Blood Establishments
• Biologics Procedures (SOPPs)
• Biologics Rules
• Rules & Regulations
• FDA Federal Registers (FR)
• Federal Food, Drug, and Cosmetic Act (FD&C Act)
• Other Laws Affecting FDA
• Dockets Management
Establishment Registration
• Blood Establishment Registration and Product Listing
• Tissue Establishment Registration
Product Development
• Investigational New Drug (IND) or Device Exemption (IDE) Process (CBER)
• Clinical Investigator Information
Product Application and Approval
• Biologics License Applications (BLA) Process (CBER)
• Premarket Approval (PMA) Process (CBER)
• New Drug Application (NDA) Process (CBER)
• 510(k) Process (CBER)
• Advertising & Labeling (Biologics)
• Manufacturers Assistance (CBER)
Postmarketing, Compliance and Enforcement
• Biologics Post-Market Activities
• Biologic Product Security
• Biologic Product Shortages
• Compliance Programs (CBER)
• Impact of Severe Weather Conditions on Biological Products
• Importing & Exporting (Biologics)
• Lot Distribution Database (LDD)
• Product Surveillance (CBER)
• Recalls (Biologics)
• Report a Problem to the Center for Biologics Evaluation & Research
• Direct Recall Classification Program (Blood and Plasma)
• Safety & Availability (Biologics)
• Untitled Letters (CBER)
• Guide to Inspections of Lyophilization of Parenterals
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074909.htm
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm095598.htm
Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections Program 7356.002
Regards,
Govind.
