SOP Guidelines

About Book

ISBN 987765654433
Presentation Hardbound, 664 Pages
Edition 3rd Edition 2018
Weight 1.25 Kg
Author DH Shah
Price USD 100
Availability In Stock

The definitive guide to standard operating procedures for the pharmaceutical industry, this new Third Edition 2018 is the most practical book, that is a must-have on the desk of any pharmaceutical manufacturing person and in the library of all pharmaceutical industry and pharmacy colleges. It contains actual usable SOPs that can be directly implemented in today’s manufacturing operations. The new revised edition is completely updated and contains over 50 percent more content than the previous edition. Over 400 SOPs are included spread over all major sections of pharmaceutical dosage form manufacture.

CONTENTS

 

Introduction

Introduction to the Second Edition

Preface to the First Edition

 

1                             DESIGNING EFFECTIVE SOPs

1.1                          Introduction and Purpose of SOPs

1.2                          Benefits of SOPs

1.3                          Types of SOPs

1.4                          Contents of a Typical SOP

1.5                          Level of Detail

1.6                          Writing Style

1.7                          SOP Development

1.7.1                       Create/Edit

1.7.2                       Review

1.7.3                       Approve

1.7.4                       Publish

1.7.5                       Distribute

1.7.6                       Archive

1.8                          SOP Format

1.8.1                       Title Page

1.8.2                       Table of Contents

1.8.3                       Text

1.9                          Transition to Electronic SOPs

1.9.1                       Too Many Documents

1.9.2                       Over-complex Documents

1.9.3                       Inappropriate Format

1.9.4                       Management Systems

1.10                        Advantages of Electronic SOPs

1.11                        System Requirements

1.12                        Structure of eSOP System

1.12.1                    Audit Critical Activities

1.12.2                    Authenticate Users

1.12.3                    Keep Track of Who Has Seen What

1.12.4                    Validation Support

1.13                        Future of eSOP

 

2                             ELECTRONIC MANUFACTURING – eMANUFACTURING

2.1                          Understanding the ‘e’ in the eManufacturing

2.1.1                       Electronic Records

2.1.2                       Requirements for Electronic Records

2.1.3                       Risk Based Approach to Future

2.2                          Purpose of eManufacturing

2.3                          Introduction to Electronic Batch Records (EBR)

2.4                          Benefits of Electronic Batch Records (EBR)

2.5                          Plant Efficiencies

2.5.1                       Impact of QC Lab on Batch Cycle Time

2.6                          Management of Manufacturing Data

2.7                          User Requirement Specification (URS)

2.8                          Vendor Selection

2.9                          Qualification and Validation of Software

2.10                        Evolution from Paper to EBR

2.11                        Features of cGMP Compliant EBR System

2.12                        Process Historian for Management of Manufacturing Data

2.13                        Enterprise Resource Planning for Pharmaceuticals

2.13.1                    Implementation

2.13.2                    ERP for Small and Medium Business (SMB)

2.13.3                    Pharmaceutical Applications of ERP

2.14                        IT Infrastructure for Pharmaceutical Industry

2.15                        SOP for Standard Operating Procedures

 

OSD                        ORAL SOLIDS MANUFACTURING SECTION

OSD-CM                 Cleaning and Maintenance

OSD-CM-01           Cleaning and Assembly of Compression Machine

OSD-CM-02           Cleaning and Assembly of Strip Sealing Machine

OSD-CM-03           Cleaning of Autoloader

OSD-CM-04           Cleaning of Capsule Inspection cum Polishing Machine

OSD-CM-05           Cleaning of Conventional Coating Pan

OSD-CM-06           Cleaning of Double Cone Blender

OSD-CM-07           Cleaning of Dry Syrup Powder Filling Machine

OSD-CM-08           Cleaning of Dust Exhausts

OSD-CM-09           Cleaning of Fluid Bed Dryer

OSD-CM-10           Cleaning of Manual Capsule Filling Machine

OSD-CM-11           Cleaning of Mass Mixer

OSD-CM-12           Cleaning of Multimill

OSD-CM-13           Cleaning of Octagonal Blender

OSD-CM-14           Cleaning of Planetary Mixer

OSD-CM-15           Cleaning of Polishing Pan

OSD-CM-16           Cleaning of Prefilter of Fluid Bed Drier

OSD-CM-17           Cleaning of Rapid Mixer Granulator

OSD-CM-18           Cleaning of Semi-Automatic Capsule Filling Machine

OSD-CM-19           Cleaning of Sifter

OSD-CM-20           Cleaning of Spray Gun

OSD-CM-21           Cleaning of Tablet Department

OSD-CM-22           Cleaning of Tray Dryer

OSD-CM-23           Cleaning of Vibratory Tablet De-Duster

OSD-CM-24           Cleaning of Wurster Coater Drier

OSD-CM-25           Validation of Cleaning Procedure

OSD-CM-26           Housekeeping – General

OSD-CM-27           Housekeeping - Pest Control and Disinfection

OSD-CM-28           Housekeeping - Storing Used Mop

OSD-CM-29           Housekeeping - Use of Floor Wiper

OSD-CM-30           Housekeeping - Vacuum Cleaner Operation and Cleaning

OSD-CM-31           Housekeeping Check Points for Capsule Department

OSD-CM-32           Housekeeping in Tablet Compression/Packaging Area

OSD-CM-33           Inspection of Punches and Dies

OSD-CM-34           Operation of Punch Polishing Machine

OSD-CM-35           Setup and Operation of Tablet Punch Polisher

 

OSD-OP                 Operations

OSD-OP-01           Operation of Autoloader

OSD-OP-02           Operation of Blister Packing Machine

OSD-OP-03           Operation of Capsule Inspection cum Polishing Machine

OSD-OP-04           Operation of Conventional Coating Pan

OSD-OP-05           Operation of Double Cone Blender

OSD-OP-06           Operation of Fluid Bed Dryer

OSD-OP-07           Operation of Multimill

OSD-OP-08           Operation of Octagonal Blender

OSD-OP-09           Operation of Paste Preparation Vessel

OSD-OP-10           Operation of Pouch Packing Machine

OSD-OP-11           Operation of Pre-Sifting

OSD-OP-12           Operation of Punch Polishing Machine

OSD-OP-13           Operation of Rapid Mixer Granulator

OSD-OP-14           Operation of Semi-Automatic Capsule Filling Machine

OSD-OP-15           Operation of Spheronizer

OSD-OP-16           Operation of Strip Packing Machine

OSD-OP-17           Operation of Tray Drier

OSD-OP-18           Operation of Wurster Coater Dryer

OSD-OP-19           Sifting of Powdered Excepient/Active Material

OSD-OP-20           Startup Tablet Process

OSD-OP-21           Strip Packing - Sealing Test

 

OSD-MG                Management

OSD-MG-01          Charge Hand Over Between the Shifts

OSD-MG-02          Destruction of Granules Bulk/Tablets

OSD-MG-03          Disposal Operation in Tablet Department

OSD-MG-04          Documentation - Authorization for Change

OSD-MG-05          Documentation - Cancellation of Batch Number

OSD-MG-06          Documentation - Maintenance of Records and Reports

OSD-MG-07          Documentation Controls

OSD-MG-08          Guidelines for Inspection Checkers

OSD-MG-09          Guidelines for Polishing of Punches & Dies

OSD-MG-10          In-Process Checks on the Packaging Line

OSD-MG-11          Issues and Receipts of Punch Set

OSD-MG-12          New Equipment

OSD-MG-13          New Punch Set

OSD-MG-14          Oil Application Procedure for Compression Tools and Machine

OSD-MG-15          Packing Slip on Final Pack (On Shipper)

OSD-MG-16          Policy on Replacement of Punches

OSD-MG-17          Procedure for Closing the Capsule/Tablet Department

OSD-MG-18          Procedure for Destruction of Blister Packs

OSD-MG-19          Procedure for Opening the Tablet/Capsule Department

OSD-MG-20          Proper Attire for Production Areas

OSD-MG-21          Raw Material Dispensing Procedure

OSD-MG-22          Reconciliation of Printed Packaging Materials

OSD-MG-23          Safety Appliances

OSD-MG-24          Sieve Analysis for Lubricated Granules

OSD-MG-25          Stopping the Operation in Coating Section

OSD-MG-26          Stopping the Operation in Compression Section

OSD-MG-27          Stopping the Operation of Granulation Section

OSD-MG-28          Storage Condition for Coating Raw Material

OSD-MG-29          Storage of In-Process Tablets and Granules

OSD-MG-30          Storage of Tablet Compression Machine When Not in Use

OSD-MG-31          Storage of Tablet Compression Tooling

OSD-MG-32          Tablet Compression - In Process Controls

OSD-MG-33          Tablet Compression - Tooling

OSD-MG-34          Tabletting Operations

OSD-MG-35          Washing of Feet

OSD-MG-36          Washing of New Finger Bag Made From Epitropic Cloth

OSD-MG-37          Work in Process Standards

OSD-MG-38          Working Procedure for Capsule Department

OSD-MG-39          Working Procedure for Packing Department

 

OSD-CB                  Calibration

OSD-CB-01            Checking Punch Height

OSD-CB-02            Guidelines for Calibration of Equipment

 

OSD-TN                  Training

OSD-TN-01            Training Program for Supervisors

OSD-TN-02            Training Program for Workmen

 

ORL                        ORAL LIQUIDS MANUFACTURING SECTION

ORL-CM                 Cleaning and Maintenance

ORL-CM-01           Cleaning of Bottle Labeling Machine

ORL-CM-02           Cleaning of Filling Machine

ORL-CM-03           Cleaning of SS Water Transfer Pipe

ORL-CM-04           Cleaning of Tanks, Accessories, Utensils and Stirrers

ORL-CM-05           Cleaning Validation of Compounding Tank

ORL-CM-06           Cleaning Validation of SS Liquid Transfer Pipe

ORL-CM-07           Cleaning/Replacement of Filters for Window Air Conditioners

ORL-CM-08           Housekeeping in Liquid Oral Compounding Area

ORL-CM-09           Housekeeping in Liquid Oral Packing Area

 

ORL-OP                  Operations

ORL-OP-01            Leakage Test of Filled Bottles

ORL-OP-02            Operation and Cleaning of Filter Press

ORL-OP-03            Operation of Bottle Labeling Machine

ORL-OP-04            Operation of Colloid Mill

ORL-OP-05            Operation of Rotary Bottle Washing Machine

 

ORL-MG                 Management

ORL-MG-01           Destruction Certificate for In-Process Goods

ORL-MG-02           Fill Volume Determination

ORL-MG-03           Finished Goods Storage and Handling

ORL-MG-04           Finished Goods Verification

ORL-MG-05           In-Process Control for Liquid Orals

ORL-MG-06           Liquid Oral Filling

ORL-MG-07           Overprinting of Packaging Supplies

ORL-MG-08           Precautions for Compounding and Cleaning

ORL-MG-09           Reconciliation of Rejected and Excess Packing Materials

ORL-MG-10           Reprocessing of Products

 

ORL-CB                  Calibration

ORL-CB-01            Calibration of Compounding/Holding Vessels

 

SSD                         SEMI SOLIDS MANUFACTURING SECTION

SSD-CM                  Cleaning and Maintenance

SSD-CM-01            Cleaning and Assembly of Preparation Tank

SSD-CM-02            Cleaning and Assembly Procedure - Silverson Mixer

SSD-CM-03            Cleaning and Assembly Procedure - Tube Filling Machine

SSD-CM-04            Cleaning and Sanitization of Ointment Department

SSD-CM-05            Cleaning of Bulk Storage Drum

SSD-CM-06            Cleaning of Compounding Kettle

SSD-CM-07            Cleaning of Flooring and Wall Surfaces

SSD-CM-08            Cleaning of SS Melting Tank

SSD-CM-09            Cleaning of Utensils, Scrappers and Scoops

SSD-CM-10            Cleaning Validation of Equipment

SSD-CM-11            Housekeeping in Ointment Department

 

SSD-MG                 Management

SSD-MG-01           Controlling Microbial Contamination

SSD-MG-02           Destruction of Bulk from Tube Filling Machine

SSD-MG-03           Destruction of Rejected Goods and Packaging Materials

SSD-MG-04           In Process Controls - Manufacturing

SSD-MG-05           In Process Controls - Packaging

SSD-MG-06           In Process Fill Weight Determination

SSD-MG-07           Line Clearance

 

STR                         STERILE LIQUIDS MANUFACTURING SECTION

STR-CM                  Cleaning and Maintenance

STR-CM-01            Cleaning & Disinfection of Sterile Area Class 10,000 and Class 100

STR-CM-02            Cleaning & Disinfection of the Sterile Area Class 10000 after Media Filling

STR-CM-03            Cleaning and Assembly of Rubber Stopper Washing Machine

STR-CM-04            Cleaning and Maintenance of Autoclave

STR-CM-05            Cleaning and Storage of Equipment for Sterile Products

STR-CM-06            Cleaning of Area after Power Failure

STR-CM-07            Cleaning of Bronze Sintered Filter (for Compressed Air)

STR-CM-08            Cleaning of Compounding/Filtration Tanks and Homogenizer

STR-CM-09            Cleaning of Holding Vessels

STR-CM-10            Cleaning of Labeling Machines

STR-CM-11            Cleaning of Membrane Filter Holder

STR-CM-12            Cleaning of Micro Metallic SS Spargers/Filters

STR-CM-13            Cleaning of Non Sterile Manufacturing Areas

STR-CM-14            Cleaning of the Autoclave Chamber

STR-CM-15            Cleaning of the Header Tank (DM Water Reservoir)

STR-CM-16            Cleaning of the Stirrer

STR-CM-17            Cleaning of Vial Sealing Machine

STR-CM-18            Cleaning of Vial/Ampoule Inspection Machine

STR-CM-19            Cleaning Procedure for Ampoule Filling and Sealing Machine

STR-CM-20            Cleaning Procedure for Distilled Water Storage Tank

STR-CM-21            Cleaning Procedure for DM Water Surge Tank

STR-CM-22            Cleaning Procedure for Vials /Ampoules Washing Machine

STR-CM-23            Cleaning Validation for Equipment

STR-CM-24            DM Water Filter Cleaning

STR-CM-25            Inspection, Cleaning and Maintenance of Sterilizing Ovens

STR-CM-26            Routine Washing of Micro Metallic Spargers

STR-CM-27            Rubber Stopper Treatment

STR-CM-28            Washing and Assembly of Membrane Filter Holder

STR-CM-29            Washing of the Batch Filtration Tubing

STR-CM-30            Washing of Vial /Ampoule Filling Assemblies and Accessories

STR-CM-31            Washing, Assembly and Sterilization of Filling Assemblies and Accessories (Regular and after Media Filling)

STR-CM-32            Washing, Assembly & Sterilization of Filling Assemblies and Accessories

STR-CM-33            Washing, Wrapping and Sterilization of Gloves

 

STR-OP                   Operations

STR-OP-01             Air Sampling Using Centrifugal Air Sampler

STR-OP-02             Aseptic Fill Validation

STR-OP-03             Aseptic Filling

STR-OP-04             Measurement of Dissolved Oxygen Content

STR-OP-05             Measurement of Head Space Oxygen

STR-OP-06             Operation of Ampoule Filling Machine

STR-OP-07             Operation of Ampoule Inspection Machine

STR-OP-08             Operation of Autoclave

STR-OP-09             Operation of Labeling Machine

STR-OP-10             Operation of Particle Counter

STR-OP-11             Operation of the Distillation Still

STR-OP-12             Operation of UV Intensity Meter

STR-OP-13             Operation of Vial Filling Machine

STR-OP-14             Operation of Vial Inspection Machine

STR-OP-15             Operation of Vial Labeling Machine

STR-OP-16             Oxygen Level Determination in Filling Tank

STR-OP-17             Preparation of Disinfectant Solution for Sterile Area Cleaning

STR-OP-18             Preparation of Gum for Labeling Vials and Ampoules

STR-OP-19             Preparation of Solution for pH Adjustment

 

STR-MG                  Management

STR-MG-01            Assigning Expiry Date to Drug Products

STR-MG-02            Assigning Expiry Dates to Sterilized Items

STR-MG-03            Check List of Jobs before Start-up and After Shutdown

STR-MG-04            Checking of Vial Sealing

STR-MG-05            Clean Room - Condition Monitoring (Air Changes)

STR-MG-06            Clean Room Procedures - General Guidelines

STR-MG-07            Control and Placement Plans of Biological Monitors

STR-MG-08            De-Ionized / Distilled Water Control Record

STR-MG-09            Destruction Guidelines of Vials/Ampoules at Various Stages of Production

STR-MG-10            Destruction of Batch - Sterile Products

STR-MG-11            Destruction of Rejected In-Process Goods and Packaging Materials

STR-MG-12            Destruction of Rejected Vials/Ampoules

STR-MG-13            Disposal of Rejected and Left Over Printed Packing Material

STR-MG-14            DM Water Line - Use of UV Bank

STR-MG-15            DM Water Plant Regeneration

STR-MG-16            DM Water Re-Circulation

STR-MG-17            Electronic Weighing Machine

STR-MG-18            Finished Goods at Bonded Store Room

STR-MG-19            Fumigation of Sterile Area

STR-MG-20            Good Manufacturing Practices

STR-MG-21            Handling of Terminally Sterilized and Non Sterilized Ampoules

STR-MG-22            In Process Controls

STR-MG-23            Inspection of Garments Used in the Sterile Filling Room

STR-MG-24            Inspection of Injectables for Human Use

STR-MG-25            Inspection of Sterile Preparations

STR-MG-26            Master Monitor for Sterile Area Operations

STR-MG-27            Monitoring of Flow Direction in Sterile Area

STR-MG-28            Monitoring of HEPA Filters

STR-MG-29            Monitoring of Positive Pressure, Air Temperature and Relative Humidity

STR-MG-30            Nitrogen Retention Test in Holding Vessel/Filling Vessel

STR-MG-31            Packing Start Up

STR-MG-32            Policy for Changing Filters in Non Sterile Area

STR-MG-33            Policy for HEPA Filter Changes

STR-MG-34            Procedure for Entry of Major Equipment in Sterile Area

STR-MG-35            Procedure for Entry through Dry Heat Sterilizer

STR-MG-36            Procedure for Entry to Sterile Area - Gowning

STR-MG-37            Procedure for Integrity and Pressure Hold Test of Membrane Filter

STR-MG-38            Procedure for Integrity Testing of Membrane Filters Used for Gases

STR-MG-39            Procedure for Leak Rate Test - Autoclave

STR-MG-40            Procedure for Leak Testing of Filled Ampoules

STR-MG-41            Procedure for Line Clearance

STR-MG-42            Procedure for Line Clearance - Labeling

STR-MG-43            Procedure for Material Entry into Sterile Area

STR-MG-44            Procedure for Packing (Sterile Products)

STR-MG-45            Procedure for Swab Test

STR-MG-46            Procedure for Vial / Ampoule Preparation

STR-MG-47            Reconciliation of Printed Packing Materials

STR-MG-48            Remedies for High Microbial Counts

STR-MG-49            Self Inspection

STR-MG-50            Servicing Policy - Clean Air Systems & Devices Monitoring

STR-MG-51            Sterile Room - Precautions and Restrictions

STR-MG-52            Sterility Testing of Products

STR-MG-53            Sterilization Cycles - Autoclave

STR-MG-54            Sterilization Cycles - Dry Heat Sterilizer

STR-MG-55            Storage Conditions for In-Process Goods

STR-MG-56            Unloading of Sterile Charge of Autoclave

STR-MG-57            Unloading of Sterile Charge of Dry Heat Sterilizer

STR-MG-58            Validation of Dry Heat Sterilizer

STR-MG-59            Validation of the Autoclave

STR-MG-60            Yield and Reconciliation Controls

 

STR-CB                   Calibration

STR-CB-01             Calibration and Validation Program

STR-CB-02             Calibration of 12 Point Temperature Indicator

STR-CB-03             Calibration of Dial Type Hygrometer

STR-CB-04             Calibration of Instruments Installed on Autoclave

STR-CB-05             Calibration of Magnehelic Gauge

STR-CB-06             Calibration of Oxygen Analyzer

STR-CB-07             Calibration of Pressure Gauge Used for Membrane Integrity Test

STR-CB-08             Calibration of Thermocouple of Temperature Measuring Devices for Autoclave

STR-CB-09             Calibration of Thermocouple of Temperature Measuring Devices of Dry Heat Sterilizer

STR-CB-10             Calibration of Volume of Compounding Tanks

 

STR-TN                   Training

STR-TN-01             Training Program - Design and Format

STR-TN-02             Training Program for Autoclave

STR-TN-03             Training Program for Dry Heat Sterilizer

STR-TN-04             Training Program for Janitors

STR-TN-05             Training Program for Laminar Air-Flow

STR-TN-06             Training Program for Membrane Filter Holder

STR-TN-07             Training Program for Personal Hygiene

STR-TN-08             Training Program for Production Supervisor

STR-TN-09             Training Program for Sterile Stoppering

STR-TN-10             Training Program for the Workmen

STR-TN-11             Training Program for Vial Sealing

 

QCL                        QUALITY CONTROL LABORATORY SECTION

QCL-CM                 Cleaning and Maintenance

QCL-CM-01           Cleaning of Glassware for Analytical Work

QCL-CM-02           Cleaning Procedure for Microbiology Lab

QCL-CM-03           Servicing of Fume Chamber in QC Department

 

QCL-OP                  Operations

QCL-OP-01            Operation and Calibration of Bacteriological Incubator

QCL-OP-02            Operation and Calibration of Balance (Electronic)

QCL-OP-03            Operation and Calibration of Balance (Platform)

QCL-OP-04            Operation and Calibration of Balance (Single Pan)

QCL-OP-05            Operation and Calibration of BOD Incubator

QCL-OP-06            Operation and Calibration of Bursting Strength Tester

QCL-OP-07            Operation and Calibration of Colony Counter

QCL-OP-08            Operation and Calibration of Compound Microscope

QCL-OP-09            Operation and Calibration of Disintegration Test Apparatus

QCL-OP-10            Operation and Calibration of Dissolution Test Apparatus

QCL-OP-11            Operation and Calibration of FTIR Apparatus

QCL-OP-12            Operation and Calibration of Friability Test Apparatus

QCL-OP-13            Operation and Calibration of IR Moisture Balance

QCL-OP-14            Operation and Calibration of Melting Point Apparatus

QCL-OP-15            Operation and Calibration of Oven

QCL-OP-16            Operation and Calibration of pH Meter

QCL-OP-17            Operation and Calibration of Photo-Fluorometer

QCL-OP-18            Operation and Calibration of Polarimeter

QCL-OP-19            Operation and Calibration of Refractometer

QCL-OP-20            Operation and Calibration of Spectrophotometer

QCL-OP-21            Operation and Calibration of Vernier Caliper

QCL-OP-22            Operation and Calibration of Zone Reader

QCL-OP-23            Operation and Validation of Autoclave

QCL-OP-24            Operation and Validation of Laminar Flow

QCL-OP-25            Operation of Bulk Density Apparatus

QCL-OP-26            Operation of Centrifuge Machine

QCL-OP-27            Operation of Hardness Tester

QCL-OP-28            Operation of Molybdenum Kit

QCL-OP-29            Operation of UV Cabinet

QCL-OP-30            Operation of Vacuum Oven

QCL-OP-31            Operation and Cleaning of Milli-Q Gradient Water Purification System  

QCL-OP-32            Operation and Cleaning of Alltech Model 3000 Solvent Recycler

QCL-OP-33            Operation, Cleaning and Calibration of MS/MS Detector Model Micromass Quattro Ultima

QCL-OP-34            Operation, Cleaning and Calibration of Rotary Shaker

QCL-OP-35            Operation and Performance Verification of Heto Ultra Deep Freezer

QCL-OP-36            Operation and Calibration of Ultrasonic Cleaner

QCL-OP-37            Operation and Calibration of Electro-Lab Dissolution Tester with Auto Sampler

QCL-OP-38            Procedure for Documentation of Analytical Data

QCL-OP-39            Operation and Performance Verification of Kompakt UV Cabinet

QCL-OP-40            Operation and Performance Verification of Panalytical X-Ray Diffractometer

QCL-OP-41            Operation and Calibration of Halogen Moisture Analyzer Model: HR83, Mettler Toledo

QCL-OP-42            Operation of Milli-Q Gradient Water Purification System ELIX-10

QCL-OP-43            Operation and Performance Verification of Retsch Mixer Miller Model MM 200

QCL-OP-44            Operation and Calibration of Lab India Dissolution Tester

QCL-OP-45            Operation and Calibration of Pierce Reacti-Vap III Evaporator

QCL-OP-46            Operation and Performance Verification of Cooling Incubator

QCL-OP-47            Operation and Performance Verification of HPLC System

QCL-OP-48            Qualification of Analysts in Laboratory

QCL-OP-49            Operation and Performance Verification of Hot Air Oven

QCL-OP-50            Operation and Performance Verification of VK Bio-Dis Extended Release Tester With Dissolution Sampling Station

QCL-OP-51            Operation and Performance Verification of Gas Chromatograph with Headspace Sampler and Auto Injector

QCL-OP-52            Operation and Calibration of Karl Fischer Auto Titrator

QCL-OP-53            Operation and Calibration of Photostability Chamber

QCL-OP-54            Cleaning and Drying of HPLC/GC Vials and Caps

QCL-OP-55            Operation and Calibration of Ultrasonic Bath

QCL-OP-56            Operation and Calibration of Dissolved Oxygen Meter

QCL-OP-57            Handling of Cleaning Validation Samples for Microbial Analysis

 

QCL-MG                 Management

QCL-MG-01           Analytical Method Validation

QCL-MG-02           Approval of Artwork

QCL-MG-03           Cross Functional Investigation

QCL-MG-04           Destruction of Samples Sent to Lab for Analysis

QCL-MG-05           Entry into Microbiology Lab

QCL-MG-06           Master formula Record

QCL-MG-07           Preparing for Audit

QCL-MG-08           Reference Working Standards

QCL-MG-09           Sampling and Inspection Procedure for Packing Materials

QCL-MG-10           SOP for Area Colony Test

QCL-MG-11           SOP for Changeover Analysis

QCL-MG-12           SOP for Control Samples

QCL-MG-13           SOP for Fumigation Test

QCL-MG-14           Standardization of Volumetric Solutions and Reagents

QCL-MG-15           Supervision of Analysis

 

QCL-CB                  Calibration

QCL-CB-01            Calibration of Glass Measuring Cylinders

QCL-CB-02            Calibration Program

 

QAS                        QUALITY ASSURANCE

QAS-001                Cleaning of Dispensing Equipment

QAS-002                Cleaning of Raw, Packing and Finished Goods Stores

QAS-003                Cross Contamination Control

QAS-004                Dehumidifier in Dispensing Room

QAS-005                Dispensing Procedure

QAS-006                Good Documentation Practices

QAS-007                Handling and Storage of Compressed Gas Cylinders

QAS-008                Machine Logbooks

QAS-009                Master Formula Record

QAS-010                Medical Facilities

QAS-011                Packing Material Storage and Issuing

QAS-012                Preventive Maintenance

QAS-013                Production Requirement Sheet

QAS-014                Raw Material Storage and Issuing

QAS-015                Receiving, Storage and Handling of Materials

QAS-016                Rejection or Release of Material

QAS-017                Return Goods Policy

QAS-018                Warehousing of Raw and Packing Material

QAS-019                Submission of Samples and Documents to Regulatory Affairs Department

QAS-020                Investigation of Deficiencies in Raw and Packing Materials After Release by Quality Control

QAS-021                Transfer of Rejected Batch from Production to Finished Goods Warehouse

QAS-022                Receiving, Review, Release and Storage of Analytical Documents, Method Validation / Transfer Documents

QAS-023                Training and Evaluation of QA

QAS-024                Process Validation Program of Tablet Products

QAS-025                Optimizing the Machine Speed of Blister Packing Machine

QAS-026                Preparation, Approval and Control of Record of Analysis / Analysis Report

QAS-027                Responsibilities of Quality Assurance Department

QAS-028                Preparation, Approval, Review and Control of Master Production Records (MPR)

QAS-029                Plant Quality Management Systems Review Meeting

QAS-030                Design and Management of Stability Studies

QAS-031                Monitoring and Cleaning of the Stability Chambers

QAS-032                Performance Verification and Calibration of Sensors of Walk-In Humidity Chamber

QAS-033                Cleaning of Sampling Aids

QAS-034                Precautions for Handling Potent Drug Substances

QAS-035                Handling Inspections by International Regulatory Agencies

QAS-036                Certification of Contract Laboratories and Agencies for Calibration and Validation Services

QAS-037                Operation and Calibration of Sartorius Precision Balance

QAS-038                Reporting, Investigation and Disposition of Incidents

 

QAS-039                Self Inspection

QAS-040                Packaging of Multiple Semi Finished Batches Into a Single Finished Goods Batch of Same Product

QAS-041                Product Inspection for Physical Defects

QAS-042                Collecting Unit Dose Blend Samples

QAS-043                Evaluation of Effect of Physical Conditions, Temperature on Consignments During Transport

QAS-044                Handling of Product Recalls

QAS-045                Change Control

QAS-046                Vendor Qualification

QAS-047                Investigation of Out-of-Specification (OOS) Results

QAS-048                Annual Product Review

QAS-049                Rounding Rules for Mathematical Calculations

QAS-050                Validation of Standard Cleaning Procedures

QAS-051                Cleaning of Sampling Aids

QAS-052                Master Cleaning Validation Plan, Cleaning Validation Matrix, Protocol and Report

QAS-053                Equipment Equivalency Review and Certification

QAS-054                Operation of Data Logger

QAS-055                Preventive Maintenance of Facility

QAS-056                Cleaning and Sanitation of Toilets

QAS-057                Check List for Facility Maintenance


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