Buy standard operating procedures for GMP site

GMP Quality Assurance and Compliance Procedures

QMS-005 How to Write Standard Operating Procedure........................................................................................................

QMS-010 All Documents - Classification, Definition and Approval Matrix.......................................................................

QMS-015 GMP Quality Documentation Management and Change Control...................................................................

QMS-020 Documentation Rule for GMP Documents..............................................................................................................

QMS-025 GMP Quality Documentation - Control, Tracking and Distribution.................................................................

QMS-030 Preparation, Maintenance and Change Control of Master Documents .....................................................

QMS-035 Pharmaceutical Deviation Report System..............................................................................................................

QMS-040 Shelf Life of Product.......................................................................................................................................................

QMS-045 Vendor Selection and Evaluation Procedure........................................................................................................

QMS-050 Vendor Certification Procedure..................................................................................................................................

QMS-055 Pharmaceutical Product Complaint Procedure...................................................................................................

QMS-060 Annual Product Review.................................................................................................................................................

QMS-065 Manufacturing Rework Procedure

QMS-070 Responsibility of Authorized Person .........................................................................................................................

QMS-075 Procedure for Product Identification and Traceability .....................................................................................

QMS-080 GMP Audit Procedures .................................................................................................................................................

QMS-085 Example of Checklist for Batch Documentation....................................................................................................

QMS-090 Evaluation of Batch Documentation and Release for Sale .............................................................................

QMS-095 GMP Training Procedure...............................................................................................................................................

QMS-100 How to Write GMP Training Materials ......................................................................................................................

QMS-105 House Keeping Audit Procedure................................................................................................................................

QMS-110 Management and Control of Contract Work..........................................................................................................

QMS-115 Criteria for Sourcing of Raw Materials, Packaging Components & Finished Goods................................

QMS-120 Quality Concern Investigation Process.....................................................................................................................

QMS-125 Change Management System......................................................................................................................................

QMS-130 Cross Functional Investigation.....................................................................................................................................

GMP Audit Training Manuals

Audit - 01 Auditing Principles for GMP Audit ...........................................................................................................................

Audit - 02 Understanding Worldwide Regulatory Requirements ......................................................................................

Audit - 03 Auditing a Personnel & Training System................................................................................................................

Audit - 04 Auditing a Deviation Management System............................................................................................................

Audit - 05 Auditing a Validation System......................................................................................................................................

Audit - 06 Auditing a Change Management System...............................................................................................................

Audit - 07 Auditing a Complaint System......................................................................................................................................

Audit - 08 Auditing a Documentation System............................................................................................................................

Audit - 09 Auditing a Calibration, Preventative Maintenance & Housekeeping System............................................

Audit - 10 Auditing Computerised Systems.................................................................................................................................

Audit - 11 Auditing Utilities System................................................................................................................................................

Audit - 12 Auditing Warehouse and Distribution System......................................................................................................

Audit - 13 Auditing Environmental Monitoring System...........................................................................................................

Audit - 14 Auditing Microbiology and Sterility Testing Laboratory......................................................................................

Audit - 15 Auditing an Analytical Quality & Stability Testing Laboratory.........................................................................

Audit - 16 Auditing a Material Handling System......................................................................................................................

Audit - 17 Auditing an Active API Manufacturer......................................................................................................................

Audit - 18 Auditing Packaging Material Vendors.....................................................................................................................

Audit - 19 Auditing a Packaging and Labeling Operation ..................................................................................................

Audit - 20 Auditing an Aseptic Sterile Area................................................................................................................................

Audit - 21 Auditing an Excipient Supplier..................................................................................................................................

Audit - 22 Auditing an Oral Solid Solution Area.......................................................................................................................

GMP Process/Cleaning/Method/Computer Validation

VAL-005 Validation - Concept and Procedure .........................................................................................................................

VAL-010 Revalidation Procedure...................................................................................................................................................

VAL-015 Method Validation Procedure.......................................................................................................................................

VAL-020 Procedure for Cleaning Validation..............................................................................................................................

VAL-025 Validation of Laboratory Instruments........................................................................................................................

VAL-030 Equipment Specification and Qualification.............................................................................................................

VAL-035 In-House Trial Procedure................................................................................................................................................

VAL-040 Computer System Validation..........................................................................................................................................

VAL-045 Impact Assessment for Computerised Systems.......................................................................................................

VAL-050 Functional Testing Guide for Computerised System..............................................................................................

VAL-055 Design Qualification Guidelines ..................................................................................................................................

VAL-060 Protecting Reliability of Electronic GMP Documents.............................................................................................

VAL-065 Cleaning, Derouging and Passivation of the Stainless Steel Parts WFI ........................................................

VAL-070 Cleaning Validation Analytical Methods ..................................................................................................................

VAL-075 Validation Deviation Management ............................................................................................................................

VAL-080 Validation Master Plan

VAL-085 Process Validation Guideline.........................................................................................................................................

VAL-090 Equipment Validation Guideline..................................................................................................................................

VAL-095 Facility and Utility Validation Guideline.....................................................................................................................

VAL-100 Process Validation Sampling.........................................................................................................................................

VAL-105 Raw Material Evaluation Process................................................................................................................................

VAL-110 Computer Validation Guideline....................................................................................................................................

VAL-115 Process Validation for Liquid and Solid Dosage Manufacturing.....................................................................

VAL-120 Cleaning Validation Guideline......................................................................................................................................

VAL-125 Guideline for the development of a Validation Project Plan..............................................................................

VAL-130 Guideline For The Development of A Computer Validation Project Plan.......................................................

VAL-135 Risk Assessment for Computer Validation Systems...............................................................................................

VAL-140 Development of a User and Functional Requirement Specification...............................................................

VAL-145 Development of A Functional Requirement Specification for Computer Systems......................................

VAL-150 Conducting an Electronic Record and Signature Assessment.........................................................................

VAL-155 Handling of Material Used for Trials...........................................................................................................................

VAL-160 Periodic Review of Systems and Processes..............................................................................................................

VAL-165 Packaging Trials.................................................................................................................................................................

Quality Control Analytical Laboratory Procedures

LAB-005 Retest Dating of Raw Materials....................................................................................................................................

LAB-010 Calibration Policies for Laboratory Instruments.....................................................................................................

LAB-015 Archiving Laboratory Documentation........................................................................................................................

LAB-020 Management of Reference Substances....................................................................................................................

LAB-025 Laboratory Workbook......................................................................................................................................................

LAB-030 Creation of Certificate of Analysis................................................................................................................................

LAB-035 Managing Analytical Reagents....................................................................................................................................

LAB-040 Laboratory Waste Management..................................................................................................................................

LAB-045 Retention Samples Management in Laboratory.....................................................................................................

LAB-050 Laboratory Supplier Approval.......................................................................................................................................

LAB-055 Laboratory Results Out of Specification Investigation..........................................................................................

LAB-060 Laboratory Testing and Documentation of Raw Materials.................................................................................

LAB-065 Laboratory Testing and Documentation of Finished Products..........................................................................

LAB-070 Preparation and Maintenance of Stability Protocols for pharmaceuticals Products...............................

LAB-075 Stability and Trial Testing Procedure for pharmaceuticals Products.............................................................

LAB-080 Preparation of Disinfactant solution IPA..................................................................................................................

LAB-085 Laboratory Analytical Determinations.......................................................................................................................

LAB-090 HPLC Reproducibility, Column Performance and Testing Guidelines............................................................

LAB-095 HPLC Method Development & Validation Procedure...........................................................................................

LAB-100 Laboratory In Process and Finished Product Quality Control..........................................................................

LAB-105 Laboratory Housekeeping and Glassware Cleaning............................................................................................

LAB-110 Safety Procedure in Laboratory...................................................................................................................................

LAB-115 Use and Control of laboratory Chemical Materials...............................................................................................

LAB-120 Qualification of Laboratory Instruments...................................................................................................................

LAB-125 Sampling of Raw Materials, In-process and Bulk Finished Product..............................................................

LAB-130 Stability Management Procedure................................................................................................................................

LAB-135 Validation of Analytical Test Procedure....................................................................................................................

Microbiology Laboratory|Sterility Testing Procedures

MICLAB-005 Entry Procedure for Sterile Filling Areas............................................................................................................

MICLAB-010 Validation of Aseptic Gowning Procedures......................................................................................................

MICLAB-015 Microbiological Data Recording Procedure.....................................................................................................

MICLAB-020 Destruction of Biological Waste in Microbiology Laboratory......................................................................

MICLAB-025 Depyrogenation of Glassware in Microbiology Laboratory Oven..............................................................

MICLAB-030 Media Preparation in Microbiology Laboratory..............................................................................................

MICLAB-035 Aseptic Media Filling and Microbiology Integrity Leak (Soup) Testing Procedure..............................

MICLAB-040 Aseptic Media Filling and Soup Test Guideline...............................................................................................

MICLAB-045 Environmental and Plant Hygiene Monitoring Procedure...........................................................................

MICLAB 050 Microbial Limit Testing Procedure by Using Laminar Flow Cabinets.......................................................

MICLAB-055 Microbiological Monitoring of Plant Water Systems.......................................................................................

MICLAB-060 Micro Laboratory Procedure for Sterility Testing.............................................................................................

MICLAB-065 Determination of Heat Resistance of Spore Forming Organisms..............................................................

MICLAB-070 Identification of Microorganisms to Genus and Species Level..................................................................

MICLAB-075 Micro Evaluation on Bioburden, Non sterile and Raw Materials.............................................................

MICLAB-080 Bacterial EndoToxin Testing (LAL) - Gel Clot Method.....................................................................................

MICLAB-085 Bacterial EndoToxin Testing kCA Method..........................................................................................................

MICLAB-090 Stock Suspensions of Micro Organisms.............................................................................................................

MICLAB-095 Sterile Sampling Procedure for Microbiology Laboratory............................................................................

MICLAB 100 Microbiological Testing of Compressed Gasses .............................................................................................

MICLAB-105 Gel Clot Validation Method.....................................................................................................................................

MICLAB-110 Laboratory Investigation and Retest Procedure for Atypical and OOS Results..................................

MICLAB-115 Operation and Calibration of Sievers 820 TOC Analyser.............................................................................

MICLAB 120 IPA Contamination Testing Procedure...............................................................................................................

MICLAB-125 Control of Microbiology Test Methods.................................................................................................................

MICLAB-130 Handling of Test Sample in Microbiology Laboratory...................................................................................

MICLAB-135 Documentation Requirement For Micro Test Method Validation.............................................................

MICLAB-140 Maintenance of Culture Collection......................................................................................................................

SOP for Packaging Operation

MAN-005 Clothing Requirements Inside the Factory Area...................................................................................................

MAN-010 Cleaning Responsibilities and Methods for Employees......................................................................................

MAN-015 Factory Cleaning Procedure........................................................................................................................................

MAN-020 Manufacturing Pest Control Procedure...................................................................................................................

MAN-025 Tours of Factory................................................................................................................................................................

MAN-030 Management of Production Logbook........................................................................................................................

MAN-035 Examples of Packaging Configuration for Production Line...............................................................................

MAN-045 Checking Requirements of Components Prior to Use..........................................................................................

MAN-050 Safety Tag Out Procedure.............................................................................................................................................

MAN-055 Procedures for Line Clearance, Line Opening and Line Cleaning.................................................................

MAN-060 Reconciliation Procedure of Component and Product.......................................................................................

MAN-065 Example-Operation of Barcode Reader....................................................................................................................

MAN-070 Example-IBC Operation and Cleaning......................................................................................................................

MAN-075 Example of a Tablet Packing Machine -Construction, Operation and Cleaning.......................................

MAN-080 Example of Manufacturing Instruction for Tablet Packing...............................................................................

MAN-085 Mop Cleaning Procedure..............................................................................................................................................

MAN-090 Scheduling of Production Lines..................................................................................................................................

MAN-095 Vacuum Leak Testing Procedure forFinished Goods..........................................................................................

MAN-100 Weighing Equipment - Checking and Calibration................................................................................................

MAN-110 Example of Operation of automatic Checkweigher for Finished Packs........................................................

MAN-115 Machine Start up Challenges and In-Process Testing Procedures................................................................

MAN-120 Finished Pack Sampling by Production Personnel..............................................................................................

Warehouse Management Procedures

PUR-005 Material Purchasing Information Record and Source List ...............................................................................

PUR-010 Generation of Purchase Order For Inventory and Consumables....................................................................

WAR-005 Procedure for Receipt of Incoming Goods..............................................................................................................

WAR-010 Incoming Raw Materials and Components-Handling by QC Sampler..........................................................

WAR-015 Warehouse Processing Issues, Returns and Rejects..........................................................................................

WAR-020 Dispatch of Goods From Warehouse........................................................................................................................

WAR-025 Warehouse Inventory Management Procedure...................................................................................................

WAR-030 Design of Warehouse Locations and Storage Area.............................................................................................

WAR-040 Finished Goods Transfer to Quarantine and Distribution Warehouse.........................................................

WAR-045 Sampling Procedure of Raw Materials....................................................................................................................

WAR-050 Sampling of Components and Printed Materials.................................................................................................

WAR-055 Work in Progress Area...................................................................................................................................................

WAR-060 Safety Procedure of Warehouse Racking...............................................................................................................

WAR-065 Forklift Operation in Warehouse................................................................................................................................

WAR-075 Example of Tablet Dispensary Procedure...............................................................................................................

WAR-080 Example of Tablet Sampling Procedure as Raw Material.................................................................................

Environmental Health and Safety Procedures

EHS-005 Hazardous Chemical Substance Management......................................................................................................

EHS-010 Environmental, Health and Safety Risk Management.........................................................................................

EHS-015 Waste Removal Process..................................................................................................................................................

EHS-020 Identifying EHS Issues......................................................................................................................................................

EHS-025 EHS Incident Management Procedure......................................................................................................................

EHS-030 First Aid Procedure ..........................................................................................................................................................

Click on the category links below

GMP SOPs