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All Products Quality Management Systems Manuals Analytical Microbiology Laboratory Manuals Process, Cleaning, Method Computer Validation Sterile Non Sterile Manufacturing Operation Manual

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All Products Quality Management Systems Manuals Analytical Microbiology Laboratory Manuals Process, Cleaning, Method Computer Validation Sterile Non Sterile Manufacturing Operation Manual

QMS MANUAL- 015 GMP Training System

QMS MANUAL- 052 Deviation Management

QMS MANUAL- 067 Electronic Records and Electronic Signatures

LAB MANUAL - 026 Out of Specification Results Investigation

LAB MANUAL - 001 Environmental Monitoring

QMS MANUAL- 002 Product Quality Complaint Handling

LAB MANUAL - 024 Trending of Stability Data

QMS MANUAL- 023 Receipt, Approval and Use of Labels and Labeling

VAL MANUAL- 013 Cleaning and Cleaning Validation of API Plant and Equipment

QMS MANUAL- 058 Calibration

VAL MANUAL- 001 The Preparation of Validation Master Plan

QMS MANUAL- 008 Quality Risk Management Application Critical Instrument Calibration

QMS MANUAL- 051 Quality Risk Management Application to Identify Deviations vs. Events

QMS MANUAL- 009 Quality Agreements - PART 1

QMS MANUAL- 012 Structured On-the-Job Training System

QMS MANUAL- 021 Annual Product Records Review - PART 1

QMS MANUAL- 056 Batch Confirmation Certification & Release by a Qualified Person within the EU

VAL MANUAL- 010 Batch Homogeneity Demonstration of Active Pharmaceutical Ingredient Preparation

LAB MANUAL - 002 Analytical Laboratory Management

QMS MANUAL- 010 Quality Agreements - PART 2

QMS MANUAL- 041 Risk Management in the Quality and Compliance Area

LAB MANUAL - 008 Transfer of Analytical Methods

QMS MANUAL- 037 Management and Documentation of Training

QMS MANUAL- 019 Quality Assurance Self-Appraisals

QMS MANUAL- 014 Auditor Training

QMS MANUAL- 032 Pest Control

VAL MANUAL- 044 Documenting IQ, OQ, PQ Protocol Test Results for Equipment, Facility and Computer

QMS MANUAL- 018 Quality and Compliance Auditing

QMS MANUAL- 042 Reduced Testing Program

QMS MANUAL- 024 Warehousing and Distribution of Commercial Products

QMS MANUAL- 011 Procedure for Quality Management of Contractors

QMS MANUAL- 060 Guideline for Development and Contents of Specifications

VAL MANUAL- 011 Documentation Models for Continuous Quality Verification

QMS MANUAL- 040 Use of a Risk-Based Approach To Establish External Quality Assurance Audit Frequency

VAL MANUAL- 036 Information Technology Infrastructure Qualification

LAB MANUAL - 015 Explanation of Repeat Testing and Retesting Utilized During

LAB MANUAL - 010 Preparation & Maintenance of Stability Protocols and Stability Master Plans

QMS MANUAL- 005 Retention and Disposal of GMP Documents and Retention Samples

LAB MANUAL - 023 Overview of Trending of Environmental Monitoring

VAL MANUAL- 006 Evaluation of Changes for Potential Impact on Process Validation

QMS MANUAL- 004 Application of Quality Risk Management to Periodic Review of SOPs

QMS MANUAL- 057 Cross Contamination Risk Evaluation Process for Commercial Compounds

QMS MANUAL- 006 Statistical Rationale for Raw Material Sampling

VAL MANUAL- 025 Periodic Review Process of Validated Equipment and Computer Systems in Pharmaceutical Industry

MFG MANUAL - 007 Maintenance and Calibration of GMP Critical Item

LAB MANUAL - 017 Reference & Retention Samples

MFG MANUAL - 005 Storage, Handling and Cleaning of Hoses Used in Pharmaceutical Production

QMS MANUAL- 061 R&D QA Audits for Suppliers and Vendors

QMS MANUAL- 062 Certificate of Analysis & Certificate of Manufacture

QMS MANUAL- 043 Stability Testing

LAB MANUAL - 007 Guideline for Stability Testing for R&D

VAL MANUAL- 054 Procedure for Identification and Sampling of Swab and Visual Inspection Locations for Medicinal Products and API Equipment

QMS MANUAL- 046 Supplier Auditing for GMP Facility

VAL MANUAL- 016 Sterilization Process Validation

QMS MANUAL- 030 Archiving, Disposal and Record Management

QMS MANUAL- 022 Annual Product Reviews - PART 2

QMS MANUAL- 047 Management of Master GMP Document

MFG MANUAL - 003 Manufacturing Documentation

QMS MANUAL- 017 Guidelines for Regulatory Inspections

QMS MANUAL- 055 Preventive Maintenance

LAB MANUAL - 027 Analytical Procedures and Validation

VAL MANUAL- 008 In-Process and Bulk Drug Product Holding Times

QMS MANUAL- 048 Artwork Creation & Control of Printed Packaging Components

LAB MANUAL - 013 Commercial Stability Studies at Contractors

VAL MANUAL- 004 Evaluating Non-Cleaned Equipment Hold Times for Cleaning Validation Medicinal Products

VAL MANUAL- 020 Process Validation Sampling Practices for Non-Sterile Liquid and Semi Solid Drug Products

MFG MANUAL - 033 Use and Recovery of Solvents in API Manufacturing

QMS MANUAL- 059 Evaluation Process Supporting Elimination of Defined Shipment Temperature Range

QMS MANUAL- 007 Certificate of Materials Supplied to Receiving Site

QMS MANUAL- 013 Training system for Aseptic and Preparation forAseptic Operators and Support Staff

VAL MANUAL- 019 Cleaning and Cleaning Validation For Formulated Products

MFG MANUAL - 017 Preventing Cross Contamination

VAL MANUAL- 022 Process Validation Sampling for Non-Sterile Solid Dose Drug Products

QMS MANUAL- 050 Computerized Systems Risk Management

MFG MANUAL - 009 Cleaning and Sterilization of Aseptic Manufacturing Equipment

VAL MANUAL- 005 Process Validation of Bulk Drug (API and Intermediate)

QMS MANUAL- 064 Manufacture Packing and Shipping of Materials Ahead of Full QA Clearance

LAB MANUAL - 018 Laboratory Equipment Qualification - PART 1

LAB MANUAL - 022 Commercial Stability Testing For Formulated Products

QMS MANUAL- 001 Release For Commercial Use of Drug Product and API Pre-Validation and Validation Batches

QMS MANUAL- 026 Material Supplier Approval

VAL MANUAL- 023 Performance Qualification versus Process Validation

VAL MANUAL- 017 Matrices and Bracketing of Medicinal Products in Process Validation

MFG MANUAL - 011 Defining Worst Case Conditions for Aseptic Process Simulations

QMS MANUAL- 029 Compliance Improvements Plans

LAB MANUAL - 005 Sterility Testing

VAL MANUAL- 050 Systems Validation

LAB MANUAL - 014 R&D GLP QA Record Retention Procedure

VAL MANUAL- 041 Clean Pure Steam System Commissioning and Qualification Approaches & Sampling Plans

LAB MANUAL - 016 Microbiological Testing for Non Sterile Drug Product

QMS MANUAL- 038 Definition and Documentation of Raw Data

VAL MANUAL- 048 Purified Water and Water for Injection System Commissioning and Qualification Sampling Plans

QMS MANUAL- 065 Determination of Storage Periods for API Excipients Intermediates and Raw Materials

MFG MANUAL - 008 Clean Steam Systems

LAB MANUAL - 012 Commercial Stability Testing of API (Pure Bulk Drug)

VAL MANUAL- 045 Access by Regulatory Authorities and Auditors to Electronic Records

VAL MANUAL- 058 Documentation and Records for Cleaning Activities and Evaluation

VAL MANUAL- 059 Identifying Critical Process Parameters for Manufacturing of Medicinal Products

QMS MANUAL- 063 Determining Testing Patterns and Acceptance Criteria for Analytical Method Transfers

QMS MANUAL- 016 Disposal of Rejected and Waste Materials

QMS MANUAL- 031 Control of Manufacturing and Packaging Defects Non Sterile

LAB MANUAL - 019 Laboratory Equipment Qualification - PART 2

MFG MANUAL - 022 Returned Goods

VAL MANUAL- 021 Principle and Precedures of Analytical Test Method Validation for GMP Regulated Industry

VAL MANUAL- 028 The validation of facilities and system

VAL MANUAL- 009 Process Validation for Formulated Products

VAL MANUAL- 002 Clean Equipment Hold Times Establishment and Practices

VAL MANUAL- 038 Validation Considerations for Transportation of Biopharmaceutical Materials

VAL MANUAL- 049 Quality Considerations for Direct Impact Compressed Air and Nitrogen Systems

MFG MANUAL - 014 Retreatment and Blending of API & Formulated Product

QMS MANUAL- 028 Facility Based R&D QA Audit

VAL MANUAL- 018 Potential Critical Packaging Process Parameters and Validation Practices

VAL MANUAL- 043 Cycle Validation for Freeze Drying

LAB MANUAL - 004 Microbiology Laboratory Management

LAB MANUAL - 009 Storage and Expiry Dating of Analytical Reagents

QMS MANUAL- 044 Internal Quality Assurance Agreements

VAL MANUAL- 024 General Outline of Analytical Procedure Validation

VAL MANUAL- 040 Management of Change in Computerised System

LAB MANUAL - 011 Controlling the Microbiological Quality of Solid Oral Dosage Forms

VAL MANUAL- 030 Identification and Investigation of Test Deviations During Validation

QMS MANUAL- 035 Raw Materials and Packaging Materials Receipt

QMS MANUAL- 066 Risk Management Application to Establishment of Weighing Device Performance Testing Intervals

MFG MANUAL - 018 In-Process Testing, Checks and Sampling

VAL MANUAL- 031 Validation Activities during Technology Transfers

VAL MANUAL- 039 System Level Impact Assessment for Information Systems

VAL MANUAL- 027 Potential Critical Parameters for ProcessIinvolves in Formulating Solid Oral Dosage Forms

LAB MANUAL - 003 Water Quality Standard

VAL MANUAL- 053 Calculations of Residue Limits for Medicinal Product for Equipment Cleaning During Cleaning Validation

MFG MANUAL - 016 Packaging System Integrity for Sterile Medical Devices

VAL MANUAL- 007 Swab and Visual Inspection Sampling Locations Guidance for Process Equipment

VAL MANUAL- 056 Rinsate and Swab Sampling Procedure in Test Method Development and Validation

QMS MANUAL- 020 Material Status Indication

VAL MANUAL- 037 How to Investigate Unknown Chromatographic Peaks during Cleaning Validation Activity

MFG MANUAL - 010 Container Closure Integrity for Sterile Drug Products

MFG MANUAL - 013 Validation of Lyophilization Processes

MFG MANUAL - 024 Receipt Handling and Storage of Starting & Packaging Materials

VAL MANUAL- 033 Validation Documentation

QMS MANUAL- 027 Storage & Distribution of Drug Products and Medical Devices

VAL MANUAL- 014 Guidance on Selection Criteria of Dose and Toxicity Data

VAL MANUAL- 047 Packaging Process Documentation Transfer for Drug Products

LAB MANUAL - 006 Endotoxin Testing

VAL MANUAL- 042 Component Level Impact Assessment for Information System Application

LAB MANUAL - 025 Stability Considerations for Planned or Unplanned API Process Changes

LAB MANUAL - 021 Microbiological Testing in Cleaning Validation for APIs and Drug Products

VAL MANUAL- 015 Inspection Attributes in Packaging Validation of Non-Sterile Drug Products

QMS MANUAL- 039 Water Purification, Storage and Distribution For Pharmaceutical Production

VAL MANUAL- 055 How to Group Product and Equipment and Select the Worst Case Product in Cleaning Validation

VAL MANUAL- 057 Method of Visual Inspection and Quantitation in Cleaning Validation

VAL MANUAL- 060 Process Validation Approaches for Formulated Medicinal Products and Medical Devices

MFG MANUAL - 029 Assessment of Shipping Processes for Drug Products

VAL MANUAL- 035 Non-Sterile API Manufacturing Area Environmental Control

QMS MANUAL- 034 Conducting Investigations in a GMP Site

QMS MANUAL- 025 Weighing and Measuring Practices In Manufacturing Operations

QMS MANUAL- 036 Sampling of Production Materials and Finished Goods

MFG MANUAL - 028 Requirements for Facilities For Sterile and Non-sterile Drug Manufacture

MFG MANUAL - 026 Control of Packaging Operation

MFG MANUAL - 019 Prevention and Control of Fungal Contamination in Tablets

VAL MANUAL- 026 Critical Parameters for Process Involves in Formulating Semi-Solid Dosage Forms

VAL MANUAL- 032 Validation Considerations for Re-work and Re-process of API

MFG MANUAL - 004 Installation, Use and Maintenance of Metal Detectors in Pharmaceutical

MFG MANUAL - 023 Unplanned Cleanroom Power Outage Time Limit and Recovery

MFG MANUAL - 002 Management of Non-Sterile Active Pharmaceutical Ingredient Manufacturing Area

QMS MANUAL- 049 Release of API Bulk Formulated Products & Part Finished Packs

VAL MANUAL- 051 Implementation of Process Analytical Technology

MFG MANUAL - 021 Sterilization or Depyrogenation Validation for Non Product Components

MFG MANUAL - 034 Principles and Responsibilities for The Management of Change in Operations

QMS MANUAL- 033 Utility Standards

QMS MANUAL- 054 Implementation of Real Time Release

QMS MANUAL- 045 Audit of a Distribution Site

LAB MANUAL - 020 Manufacture and Microbiological Testing of Sterile API & Drug Product Within R&D

MFG MANUAL - 032 Sterile & Non Sterile Vial Capping Operations

MFG MANUAL - 012 Gamma Radiation Sterilization

MFG MANUAL - 030 Cold Chain Management of Biopharmaceutical Materials

MFG MANUAL - 020 Sanitant Rotation in a Routine Sanitization Program

VAL MANUAL- 052 Validation of Process Analytical Technology System

QMS MANUAL- 003 Evaluation of Contaminant Options for Packing of Solid Dosage Forms

VAL MANUAL- 012 Documentation to Foster Continuous Quality Verification

QMS MANUAL- 053 Study Based GLP QA Audit for Critical Phases

MFG MANUAL - 015 Lyophilizer Loading and Unloading Recommendations

MFG MANUAL - 031 Labeling and Packaging of Investigational Medicinal Products and APIs in R&D

LAB MANUAL - 028 Microbial Attributes of Non Sterile Solid Materials Testing

VAL MANUAL- 046 Material of Construction Documentation

VAL MANUAL- 029 Examples and Approaches of Solvent Recovery Validation

MFG MANUAL - 006 Alternatives to Formaldehyde Fogging of Clean Rooms

VAL MANUAL- 003 Equivalency Comparison of Medicinal Product Validation Batch Data to Reference Batches

VAL MANUAL- 034 Demonstration and Calculation of Equivalence Criteria of Impurities for API Process Validation

MFG MANUAL - 001 Considerations for Selecting Packaging Lot Sizes During Packaging

MFG MANUAL - 027 Water Activity Fundamentals and Applications in Pharmaceutical Operations

MFG MANUAL - 025 Use of Sterilized Goggles Within the Aseptic Processing Area

VAL MANUAL- 062 Use of Process Analytical Technology in Process Validation

VAL MANUAL- 061 Cleaning Validation and Verification of Equipments Used for Manufacturing Active Pharmaceutical Ingredients

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