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1、 Bethesda: 1 April 2009Pharmaceutical Development SectionValidation Master PlanFirst Draft (For review)1 April 2009Begin NIH Review2 April 2009Signature AdoptionEffective DatePharmacy Department 10 Center Drive, Room 1N257Bethesda, Maryland 20892-1196This Page Intentionally Left Blank.National Insti
2、tutes of Health, Inc.Pharmaceutical Development SectionSignature PageDocument:Validation Master PlanRevision Identification: OriginalOrigination 1 Apr 2009Facility:National Institutes of HealthDepartment of PharmacyPharmaceutical Development SectionLocation:Pharmacy Department 10 Center Drive, Room
3、1N257Bethesda, Maryland 20892-1196This Revision Date:Complete Title:Validation Master PlanObjective:The objective of this Validation Master Plan is to define the Facility, Equipment, and Process Validation requirements, methodologies, and acceptance criteria for qualification of the Pharmacy PDS liq
4、uid and solid dose manufacturing area.DocumentWritten By: Narlin BeatyTitle: Contractor - Qualification Process Solutions, LLCSignature: Date: DocumentApproved By: _Title: _Signature: Date: DocumentApproved By: _Title: _Signature: Date: DocumentApproved By: _Title: _Signature: Date: This Page Intent
5、ionally Left BlankTABLE OF CONTENTS BY SECTIONS1.INTRODUCTION, POLICY AND SCOPE82.CONCEPT OF QUALIFICATION / VALIDATION123.ORGANIZATIONAL RESPONSIBILITIES FOR VALIDATION285.CALIBRATION PROGRAM446.PREVENTATIVE MAINTENANCE PROGRAM507.KEY STANDARD OPERATING PROCEDURES REQUIRING VALIDATION548.GUIDELINES
6、 FOR SPECIFIC EQUIPMENT AND SYSTEMS609.PROCESS VALIDATIONS8810.ENVIRONMENTAL MONITORING PROGRAM I PHYSICAL TESTS12611.MICROBIOLOGICAL TESTING145This Page Intentionally Left BlankNATIONAL INSTITUTES OF HEALTHTitle: Validation Master Plan for Drug Manufacturing OperationsDocument Number:Effective Date
7、: Supersedes / Date: Section 1Page 10 of 163Contents1.Introduction, Policy and Scope21.1.Project Description21.2.Scope21.3.Definition of the Term Validation41.4.Living Document41. Introduction, Policy and Scope1.1. Project DescriptionThe objective of this Validation Master Plan is to define the Faci
8、lity, Equipment, and Process Validation requirements, methodologies, and acceptance criteria for qualification of the Pharmacy located at the National Institutes of Health Pharmacy Department (NIH/PHAR) 9000 Rockville Pike Building 10, Pharmacy, Bethesda, MD 20892.Where appropriate this document mak
9、es reference to suitable internal policies and procedures, identified by document number. Every attempt is made to generate a consistent uniform policy, however due to the revision lag that occurs when this document is updated, conflicts may occur from time to time (such as in issuing updated SOPs t
10、o reflect new policy). Where conflicts exist, the most recent document that has undergone signature review must prevail.1.2. ScopeThe Validation Master Plan (VMP) covers all of the FDA regulated cGMP items that need to be validated in order to comply with Part 21: 211 of the Code of Federal Regulati
11、ons. The VMP is not intended to be an exact prescription for the validation of processes or equipment. Instead it serves as an internal guidance document that lays out the policies of NIH/PHAR as they apply to validation.This Master Plan is limited to the NIH/PHAR and its Drug Manufacturing Operatio
12、ns, its manufacturing equipment, and dedicated or shared utility systems. The following systems / equipment / processes are addressed by this plan:Equipment NumberEquipment Name201HPLC Unit(s)202Mass Spectrometer203Polarimeter204DSC differential scanning calorimeter205CZE capillary zone electrophore
13、sis206IR infra-red spectrophotometer207Dissolution Testing Apparatus208UV ultra-violet spectrophotometer401Vial Washer402Autoclave403Depyrogenation Oven404Pass Thru405Lyophilizer406Bio-Safety Cabinet407Laminar Flow Hood408Dishwasher409Glatt, fluid bed dryer410Bio-Safety Cabinet411Dishwasher412Capsul
14、e Machine413V Blender414Tablet PressHVAC WFIPure SteamRODICompressed AirNitrogenChilled WaterIn addition to the IQ/ OQ / PQ of equipment, the plan includes processes that must be validated. These are processes that are performed by NIH/PHAR personnel and for which the validation is proving not only
