GMP SOP Shop

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

Tags

Share

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

QMS MANUAL- 052 Deviation Management

QMS MANUAL- 015 GMP Training System

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- 001 The Preparation of Validation Master Plan

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

QMS MANUAL- 058 Calibration

QMS MANUAL- 008 Quality Risk Management Application Critical Instrument Calibration

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

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

QMS MANUAL- 021 Annual Product Records Review - PART 1

QMS MANUAL- 009 Quality Agreements - 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

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

LAB MANUAL - 002 Analytical Laboratory Management

QMS MANUAL- 010 Quality Agreements - PART 2

QMS MANUAL- 037 Management and Documentation of Training

LAB MANUAL - 008 Transfer of Analytical Methods

QMS MANUAL- 019 Quality Assurance Self-Appraisals

QMS MANUAL- 014 Auditor Training

QMS MANUAL- 018 Quality and Compliance Auditing

QMS MANUAL- 024 Warehousing and Distribution of Commercial Products

QMS MANUAL- 032 Pest Control

QMS MANUAL- 042 Reduced Testing Program

QMS MANUAL- 011 Procedure for Quality Management of Contractors

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

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

LAB MANUAL - 023 Overview of Trending of Environmental Monitoring

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

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

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

QMS MANUAL- 062 Certificate of Analysis & Certificate of Manufacture

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

QMS MANUAL- 043 Stability Testing

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

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

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

MFG MANUAL - 007 Maintenance and Calibration of GMP Critical Item

VAL MANUAL- 016 Sterilization Process Validation

QMS MANUAL- 046 Supplier Auditing for GMP Facility

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

QMS MANUAL- 017 Guidelines for Regulatory Inspections

QMS MANUAL- 030 Archiving, Disposal and Record Management

LAB MANUAL - 027 Analytical Procedures and Validation

LAB MANUAL - 017 Reference & Retention Samples

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

QMS MANUAL- 022 Annual Product Reviews - PART 2

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

QMS MANUAL- 055 Preventive Maintenance

LAB MANUAL - 013 Commercial Stability Studies at Contractors

MFG MANUAL - 003 Manufacturing Documentation

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

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

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

QMS MANUAL- 047 Management of Master GMP Document

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

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

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

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

MFG MANUAL - 017 Preventing Cross Contamination

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

QMS MANUAL- 026 Material Supplier Approval

LAB MANUAL - 022 Commercial Stability Testing For Formulated Products

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

LAB MANUAL - 005 Sterility Testing

QMS MANUAL- 029 Compliance Improvements Plans

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

VAL MANUAL- 050 Systems Validation

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

VAL MANUAL- 023 Performance Qualification versus Process Validation

QMS MANUAL- 038 Definition and Documentation of Raw Data

LAB MANUAL - 016 Microbiological Testing for Non Sterile Drug Product

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

QMS MANUAL- 050 Computerized Systems Risk Management

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

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

MFG MANUAL - 008 Clean Steam Systems

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

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

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

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

MFG MANUAL - 022 Returned Goods

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

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

LAB MANUAL - 019 Laboratory Equipment Qualification - PART 2

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

VAL MANUAL- 009 Process Validation for Formulated Products

VAL MANUAL- 002 Clean Equipment Hold Times Establishment and Practices

QMS MANUAL- 016 Disposal of Rejected and Waste Materials

VAL MANUAL- 038 Validation Considerations for Transportation of Biopharmaceutical Materials

QMS MANUAL- 028 Facility Based R&D QA Audit

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

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

VAL MANUAL- 043 Cycle Validation for Freeze Drying

VAL MANUAL- 024 General Outline of Analytical Procedure Validation

VAL MANUAL- 028 The validation of facilities and system

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

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

QMS MANUAL- 044 Internal Quality Assurance Agreements

LAB MANUAL - 009 Storage and Expiry Dating of Analytical Reagents

QMS MANUAL- 035 Raw Materials and Packaging Materials Receipt

LAB MANUAL - 004 Microbiology Laboratory Management

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

VAL MANUAL- 039 System Level Impact Assessment for Information Systems

VAL MANUAL- 031 Validation Activities during Technology Transfers

LAB MANUAL - 003 Water Quality Standard

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

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

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

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 - 024 Receipt Handling and Storage of Starting & Packaging Materials

MFG MANUAL - 013 Validation of Lyophilization Processes

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- 042 Component Level Impact Assessment for Information System Application

VAL MANUAL- 047 Packaging Process Documentation Transfer for Drug Products

LAB MANUAL - 006 Endotoxin Testing

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

VAL MANUAL- 033 Validation Documentation

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

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

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

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

QMS MANUAL- 034 Conducting Investigations in a GMP Site

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

QMS MANUAL- 025 Weighing and Measuring Practices In Manufacturing Operations

QMS MANUAL- 036 Sampling of Production Materials and Finished Goods

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

MFG MANUAL - 026 Control of Packaging Operation

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

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

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

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

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

VAL MANUAL- 051 Implementation of Process Analytical Technology

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

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

QMS MANUAL- 045 Audit of a Distribution Site

QMS MANUAL- 054 Implementation of Real Time Release

MFG MANUAL - 032 Sterile & Non Sterile Vial Capping Operations

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

QMS MANUAL- 033 Utility Standards

MFG MANUAL - 030 Cold Chain Management of Biopharmaceutical Materials

MFG MANUAL - 012 Gamma Radiation Sterilization

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 - 020 Sanitant Rotation in a Routine Sanitization Program

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- 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

VAL MANUAL- 046 Material of Construction Documentation

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

Contact Us

Powered by FatFreeShop