What's in the GMP - Quality - Up

GMP|Manufacturing SOP|Quality Assurance (QA) Management|Compliance Management|Quality Control (QC) Laboratory|Microbiology Laboratory (Sterility Testing)|Audit Training|Process, Cleaning, Method Validation|Standard Operating Procedures (SOP) for Pharmaceuticals.

Step by step  pre-written standard operating procedures and manuals in the area of GMP (Good Manufacturing Practice), Manufacturing, Quality Assurance Management, Quality Control Laboratory, Process & cleaning Validation, Regulatory auditing manuals for small and medium size pharmaceutical manufacturing environments.

All  manuals and procedures are written by area experts in example formats in order to comply with  cGMP, GLP, GDP, GAMP, workplace safety etc. and international regulatory requirements.

Our goal is to provide a complete GMP & GLP model with a set of ready procedures and manuals which are easy to understand and readily applicable. All procedures are written with practical instruction examples and linked with other relevent procedures to have the clear understanding. Pocedures are grouped into seperate categories and prepared to guide you through establishing a GMP Manufacturing Environment, Quality Assurance Management, Quality Control Laboratory Management, Process Validation System, Warehouse Management, Environmental Health and Safety Systems in your pharmaceutical manufacturing site.

Content  of our procedures are not only guidelines but a complete set of operating  Instructions, Forms and Templates that will help you to build up your systems from today.

Following is a list of manuals and procedures linked with sample pages from all categories. For full version of manuals and procedures, please read more by clicking the "subscribe" button on the left.
GMP - Quality - Up
An Online Resource of Quality Assurance Procedures

  Pharmaceutical Process/Cleaning/Method Validation Procedures

  Validation - Concept and Procedure
  Revalidation Procedure
  Method Validation Procedure
  Procedure for Cleaning Validation
  Validation of Laboratory Instruments
  Equipment Specification and Qualification
  In-House Trial Procedure

 
  Pharmaceutical Computer Validation Procedures
  Computer System Validation
  Impact Assessment for Computerised Systems
  Functional Testing Guide for Computerised System
  Design Qualification Guidelines
  Protecting Reliability of Electronic GMP Documents
  Example of Installation Qualification Computer


  Validation Templates

  Cleaning Validation-Rinsing Test Template
  Cleaning Validation-Swab Test Template
  Cleaning Validation-Comparative Analysis Template
  Example of Installation Qualification Report
  Example of Operational Qualification Report
  Example of Operational Qualification Test Protocol
  Example of Performance Qualification Test Protocol
  Example of Validation Plan
  Example of Validation Report
  Example of User Requirement Specification
  Example of Commissioning Plan
  Example of Design Qualification Protocol
  Example of Installation Qualification Equipment
  Example of Installation Qualification HVAC
  Example of Installation Qualification Operating Environment
  Example of Installation Qualification Pipework
  Example of Installation Qualification Utilities
  Example of Electrical Demand Specification
  Example of Instrumentation Demand Specification
  Example of Mechanical Demand Specification 
  Example of HAZOP Report
  Example of Traceability Matrix Report
  Example of Validation Discrepancy Form
  Example of Validation Report Combined OQ_PQ
  Example of  Project Definition Report
  Example of Project Evaluation and Closeout Report
  Example of Test Protocol Change Request Form

  Study Based GLP Quality Assurance Audit for Critical Phases
  Guideline for Development and Contents of Specifications
  R&D QA Audits for Suppliers and Vendors
  Manufacture Packing and Shipping of Materials Ahead of Full QA Clearance
  Determination of Storage Periods for APIs Excipients Intermediates and Raw Materials

  Validation Manuals

  The Preparation of Process Validation Master Plan
  Process Validation of Bulk Drug (API and Intermediate)
  Process Validation for Formulated Products
  Cleaning and Cleaning Validation of API Plant and Equipment
  Sterilization Process Validation
  Cleaning and Cleaning Validation For Formulated Products
  Analytical Laboratory Procedure Validation
  The Validation of Facilities and Systems
  Information Technology Infrastructure Qualification

  GLP | R &D Manuals

  Water Quality Standard
  Sterility Testing Procedure
  Endotoxin Testing Procedure
  Guideline for Stability Testing for R&D
  Storage and Expiry Dating of Analytical Reagents in Laboratory
  Preparation & Maintenance of Stability Protocols and Stability Master Plans
  Commercial Stability Testing of API (Pure Bulk Drug)
  Commercial Stability Studies at Contractors
  R&D Laboratory Quality Assurance Record Retention Procedure
  Microbiological Testing for Non Sterile Drug Product
  Reference & Retention Samples
  Laboratory Equipment Qualification
  Manufacture and Microbiological Testing of Sterile API & Drug Product Within R&D
  Commercial Stability Testing  For Formulated Products
  Environmental Monitoring
  Trending of Stability Data
  Laboratory Out of Specification Results Investigation

  Operation Manuals

  Manufacturing Documentation
  Maintenance and Calibration of GMP Critical Items in Manufacturing Operations and R&D
  Retreatment and Blending of API & Formulated Product
  In-Process Testing, Checks and Sampling
  Management of Returned Goods
  Receipt Handling and Storage of Starting & Packaging Materials
  Control of Packaging Operation
  Requirements of Facilities For Sterile and Non-sterile  Drug Manufacturing
  Labeling and Packaging of Investigational Medicinal Products and APIs in R&D
  Principles and Responsibilities for The Management of Change in Manufacturing Operations

 
  All Quality Forms

  Form-005 Non Component Run Sheet
  Form-010 Sample Request Form
  Form-015 Warehouse Information Form
  Form-020 Bin Sheet
  Form-025 Return to Bulk Store
  Form-030 Issue for Production
  Form-035 Example-Bulk Tablet Sampling Form
  Form-040 Physical Inventory Count Form
  Form-045 Warehouse Bin Sheet Reconciliation Form
  Form-050 Warehouse Periodic Inventory Count Sheet
  Form-055 Material Transfer Order Form
  Form-060 Material Transfer Order-Interim Production Form
  Form-065 Material Transfer Order-Reject Form
  Form-070 Material Transfer Order-Return form
  Form-075 Goods Receipt Slip
  Form-080 In-House Identification Label
  Form-085 Released Stickers
  Form-090 Sampled Stickers
  Form-095 Rejected Stickers
  Form-100 Sampled Partial Stickers
  Form-105 Sampling Label
  Form-110 Pallet Racking Damage Log form
  Form-115 Warehouse Racking Checklist
  Form-120 Printed Material Sample Sheet
  Form-125 Example-Batch Reconciliation Sheet for Tablet Packing
  Form-135 Pest Sightings Reports
  Form-140 Visitor Entry Into The Factory
  Form-145 IBC Cleaning Tag
  Form-150 Example-Logbook for Tablet Batch Documents
  Form-155 Checkweigher Weight Record
  Form-160 Example- Line Clearance, Opening and Cleaning form for Tablet Packing
  Form-165 Pallet ID Form
  Form-170 Shipper Label Format
  Form-175 Vacuum Leak Test - Hourly Form
  Form-180 Vacuum Leak Test - New Foil and PVC Roll Form
  Form-185 Balance Calibration Logbook
  Form-190 Dispensary Label Form
  Form-195 InProcess Check - Shipper Form
  Form-200 InProcess Check-Blister and Carton form
  Form-205 Employee Log Form
  Form-210 Goods Booking Slip
  Form-215 Partial Shipper Stickers
  Form-220 Material Purchasing Information Record
  Form-225 Purchase Order Form
  Form-235 Monthly Production Schedule Form
  Form-240 Finished Goods Batch With Impending Expiry
  Form-245 Laboratory Master File of Instruments
  Form-250 Finished Goods Register
  Form-255 Raw Material Register
  Form-260 Finished Goods Trend Card
  Form-265 Raw Material Trend Card
  Form-270 Laboratory and QA Document Log Sheet and Box Labels
  Form-275 Workbook Checklis
  Form-280 Reagent Storage Location Form
  Form-285 Prepared Reagent Label Form
  Form-290 Chemical Waste Disposal
  Form-295 Raw Material Retention Sample Register Log
  Form-300 Finished Goods Retention Sample Register Log
  Form-305 Laboratory Investigation and Report form
  Form-310 Raw Material Out of Specification Investigation form
  Form-315 Stability or Trial Card
  Form-320 Template of Certificate of Analysis
  Form-325 Secondary RM Reference Substance (SRMRS) Summery Sheet
  Form-330 Primary and Impurity Substance Summery Sheet
  Form-335 Expired Raw Material Form
  Form-340 Trial Checklist
  Form-345 Primery Reagent Ref. Substance (PRRS) Summery Sheet
  Form-350 SRMRS Label
  Form-355 In-Process SRMRS Label
  Form-360 PRRS Label
  Form-365 Master Document Change Control Form
  Form-370 Validation Discrepancy Form
  Form-375 Validation Project Log Form
  Form-380 IBC Identification Label
  Form-385 Vendor Audit Questionnaire
  Form-390 New Supplier Assessment Form
  Form-395 SOP Ready for Signing
  Form-400 Employee Signature Register
  Form-405 Complaint Investigation Report
  Form-410 Document Location in Satellite File
  Form-415 Library Log Form
  Form-420 Request for New Chemical Approval
  Form-425 Housekeeping Audit Checksheet for Laboratory
  Form-430 Housekeeping Audit Checksheet for Production Services
  Form-435 Housekeeping Audit Checksheet for Electrical & Mechanical Workshop
  Form-440 Housekeeping Audit Checksheet for Warehouse
  Form-445 EHS Workplace Instruction Checklist
  Form-450 Deviation Report Form
  Form-455 Incident or Investigation Report Form
  Form-460 Register of Contracts
  Form-465 Complaints Details Form
  Form-470 New Chemical Approval Certificate
  Form-475 Housekeeping Audit Checksheet for Dispensary
  Form-480 New Chemical Rejection Advice
  Form-485 Housekeeping Audit Checksheet for Tablet Prodcution
  Form-490 Laboratory Testing Form For Customer Complaint Enquiry
  Form-495 Form Ready for Signing
  Form-500 Training Participant Log
  Form-505 Document Creation or Change Request
  Form-510 Product To Be Reworked
  Form-515 Goods Return for Rework Form
  Form-520 Material Transfer Order Form
  Form-525 Hazardous Chemical Assessment Checklist
  Form-530 Reading Compliance Form
  Form-535 GMP Agreement Log
  Form-540 Pallet Booking Information
  Form-545 Raw Material Sampling Log
  Form-550 Finished Goods Shipping Form
  Form-555 Example-Batch Documentation Checklist for Tablet Packing
  Form-560 Test and Retention Sample Log Book
  Form-565 QA Inspection Sheet
  Form-570 Process Data Collection Form
  Form-575 Incident Investigation Form
  Form-580 Incident Communication Form
  Form-585 Contents of First Aid Emergency Kits
  Form-590 verification of Assay Result Sheet
  Form-595 Bacterial Endotoxin Test Data
  Form-600 Maximum Valid Dilution and endotoxin Limit Calculations
  Form-605 BET Gel Clot Validation - Final inhibition and Enhancement Test
  Form-610 BET Gel Clot Validation - Preliminary inhibition and Enhancement test
  Form-615 TOC Analyser Calibration Worksheet
  Form-620 Validation For Bacterial Endotoxin Using Kinetic Chromogenic Analysis (KCA)
  Form-625 Sterile Area Sample Identification Checklist
  Form-630 Non Steaming Machine Record For Micro Lab
  Form-635 Daily Personnel Monitoring Logs for Sterile Areas
  Form-640 Sample Identification Checklist For Terminally Sterilised Products
  Form-645 Sterile Chart Log For Microbiology Laboratory
  Form-650 Checklist for Procedure for Entry into Sterile
  Form-655 Validation Record For Sterile Gowning Procedure
  Form-660 Daily Store Room Temperatures
  Form-665 Microbiological Integrity (Soup) Test
  Form-670 Aseptic Media Fill Information Sheet
  Form-675 Plant Water - Isolate Identification Record
  Form-680 Sterility Test Failure Investigation Form
  Form-685 Lal Gel-Clot Test Session Results
  Form-690 Microbiology Out of Specification (OOS) Investigation and Report Form
  Form-695 EHS Risk Profile
  Form-700 Labelling of Settle (Fallout) Plates
  Form-705 Impact Assessment Form Computerised System
  Form-710 Record Reliability Controls

Thank you for your interest in GMP-Quality-Up and Good luck to your business

GMP|Manufacturing|Quality Assurance (QA) Management|Compliance Management|Quality Control (QC) Laboratory|Microbiology Laboratory (Sterility Testing)|Audit Training|Process, Cleaning, Method Validation|Standard Operating Procedures and Manuals for Pharmaceuticals
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