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All Products Quality Assurance and Compliance SOPs Process, Cleaning, Method Computer Validation SOP Warehouse Management SOPs Manufacturing, Packaging Operation SOPs Quality Control Laboratory SOPs Microbiology Laboratory SOPs Environmental Health and Safety SOP

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All Products Quality Assurance and Compliance SOPs Process, Cleaning, Method Computer Validation SOP Warehouse Management SOPs Manufacturing, Packaging Operation SOPs Quality Control Laboratory SOPs Microbiology Laboratory SOPs Environmental Health and Safety SOP

QMS-135 Quality Risk Management Techniques

QMS-045 Vendor Selection and Evaluation Procedure

QMS-005 How to Write Standard Operating Procedure

QMS-035 Pharmaceutical Deviation Report System

QMS-015 GMP Quality Documentation Management and Change Control

VAL-020 Procedure for Cleaning Validation

QMS-090 Evaluation of Batch Documentation and Release for Sale

QMS-095 GMP Training Procedure

QMS-080 GMP Audit Procedures

QMS-055 Pharmaceutical Product Complaint Procedure

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

WAR-005 Procedure for Receipt of Incoming Goods

QMS-050 Vendor Certification Procedure

VAL-040 Computer System Validation

VAL-005 Validation - Concept and Procedure

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

QMS-085 Example of Checklist for Batch Documentation

QMS-120 Quality Concern Investigation Process

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

QMS-020 Documentation Rule for GMP Documents

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

QMS-060 Annual Product Review

VAL-080 Validation Master Plan

QMS-075 Procedure for Product Identification and Traceability

MAN-015 Factory Cleaning Procedure

QMS-125 Change Management System

WAR-025 Warehouse Inventory Management Procedure

LAB-055 Laboratory Results Out of Specification Investigation

VAL-030 Equipment Specification and Qualification

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

VAL-015 Method Validation Procedure

QMS-110 Management and Control of Contract Work

MAN-020 Manufacturing Pest Control Procedure

MAN-010 Cleaning Responsibilities and Methods for Employees

LAB-030 Creation of Certificate of Analysis

WAR-015 Warehouse Processing Issues, Returns and Rejects

QMS-105 House Keeping Audit Procedure

LAB-075 Stability and Trial Testing Procedure for pharmaceuticals Products

VAL-045 Impact Assessment for Computerised Systems

QMS-065 Manufacturing Rework Procedure

QMS-100 How to Write GMP Training Materials

LAB-010 Calibration Policies for Laboratory Instruments

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

LAB-065 Laboratory Testing and Documentation of Finished Products

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

MAN-005 Clothing Requirements Inside the Factory Area

LAB-060 Laboratory Testing and Documentation of Raw Materials

LAB-005 Retest Dating of Raw Materials

WAR-045 Sampling Procedure of Raw Materials

QMS-070 Responsibility of Authorized Person

LAB-045 Retention Samples Management in Laboratory

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

VAL-085 Process Validation Guideline

MICLAB-045 Environmental and Plant Hygiene Monitoring Procedure

WAR-020 Dispatch of Goods From Warehouse

VAL-025 Validation of Laboratory Instruments

VAL-090 Equipment Validation Guideline

VAL-010 Revalidation Procedure

LAB-130 Stability Management Procedure

LAB-020 Management of Reference Substances

VAL-120 Cleaning Validation Guideline

WAR-040 Finished Goods Transfer to Quarantine and Distribution Warehouse

LAB-025 Laboratory Workbook

LAB-035 Managing Analytical Reagents

VAL-055 Design Qualification Guidelines

VAL-135 Risk Assessment for Computer Validation Systems

VAL-110 Computer Validation Guideline

VAL-050 Functional Testing Guide for Computerised System

WAR-030 Design of Warehouse Locations and Storage Area

VAL-160 Periodic Review of Systems and Processes

LAB-135 Validation of Analytical Test Procedure

WAR-050 Sampling of Components and Printed Materials

MAN-060 Reconciliation Procedure of Component and Product

VAL-070 Cleaning Validation Analytical Methods

VAL-095 Facility and Utility Validation Guideline

MAN-100 Weighing Equipment - Checking and Calibration

EHS-010 Environmental, Health and Safety Risk Management

MAN-030 Management of Production Logbook

LAB-040 Laboratory Waste Management

VAL-115 Process Validation for Liquid and Solid Dosage Manufacturing

VAL-060 Protecting Reliability of Electronic GMP Documents

MAN-085 Mop Cleaning Procedure

LAB-015 Archiving Laboratory Documentation

LAB-120 Qualification of Laboratory Instruments

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

EHS-005 Hazardous Chemical Substance Management

QMS-130 Cross Functional Investigation

EHS-015 Waste Removal Process

PUR-010 Generation of Purchase Order For Inventory and Consumables

VAL-140 Development of a User and Functional Requirement Specification

LAB-100 Laboratory In Process and Finished Product Quality Control

VAL-100 Process Validation Sampling

MICLAB-070 Identification of Microorganisms to Genus and Species Level

MICLAB-010 Validation of Aseptic Gowning Procedures

MICLAB-055 Microbiological Monitoring of Plant Water Systems

VAL-075 Validation Deviation Management

LAB-105 Laboratory Housekeeping and Glassware Cleaning

MICLAB-060 Micro Laboratory Procedure for Sterility Testing

MAN-045 Checking Requirements of Components Prior to Use

MAN-120 Finished Pack Sampling by Production Personnel

MAN-035 Examples of Packaging Configuration for Production Line

VAL-105 Raw Material Evaluation Process

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

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

LAB-095 HPLC Method Development & Validation Procedure

WAR-055 Work in Progress Area

WAR-060 Safety Procedure of Warehouse Racking

LAB-085 Laboratory Analytical Determinations

LAB-110 Safety Procedure in Laboratory

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

VAL-150 Conducting an Electronic Record and Signature Assessment

EHS-025 EHS Incident Management Procedure

LAB-090 HPLC Reproducibility, Column Performance and Testing Guidelines

LAB-115 Use and Control of laboratory Chemical Materials

WAR-065 Forklift Operation in Warehouse

MAN-025 Tours of Factory

EHS-030 First Aid Procedure

MAN-050 Safety Tag Out Procedure

MICLAB-005 Entry Procedure for Sterile Filling Areas

VAL-065 Cleaning, Derouging and Passivation of the Stainless Steel Parts of the Purified Water System

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

MICLAB-015 Microbiological Data Recording Procedure

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

LAB-050 Laboratory Supplier Approval

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

MAN-080 Example of Manufacturing Instruction for Tablet Packing

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

MAN-090 Scheduling of Production Lines

VAL-035 In-House Trial Procedure

MICLAB-030 Media Preparation in Microbiology Laboratory

MICLAB-100 Microbiological Testing of Compressed Gasses

MICLAB-020 Destruction of Biological Waste in Microbiology Laboratory

MICLAB-095 Sterile Sampling Procedure for Microbiology Laboratory

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

MICLAB-105 Gel Clot Validation Method

MAN-095 Vacuum Leak Testing Procedure forFinished Goods

EHS-020 Identifying EHS Issues

MICLAB-090 Stock Suspensions of Micro Organisms

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

EHS-045 Building Cleaning Procedure

MICLAB-040 Aseptic Media Filling and Soup Test Guideline

VAL-165 Packaging Trials

MAN-125 Component Return Procedure From Packaging Floor

EHS-095 Pest Control

MICLAB-120 IPA Contamination Testing Procedure

MAN-070 Example-IBC Operation and Cleaning

MICLAB-135 Documentation Requirement For Micro Test Method Validation

MICLAB-140 Maintenance of Culture Collection

LAB-080 Preparation of Disinfactant solution IPA

MICLAB-085 Bacterial EndoToxin Testing kCA Method

WAR-075 Example of Tablet Dispensary Procedure

VAL-155 Handling of Material Used for Trials

MAN-065 Example-Operation of Barcode Reader

MICLAB-065 Determination of Heat Resistance of Spore Forming Organisms

EHS-085 General Security Procedure for Manufacturing Area

MICLAB-130 Handling of Test Sample in Microbiology Laboratory

EHS-130 EHS Risk Assessment Methodology

MICLAB-125 Control of Microbiology Test Methods

MICLAB-115 Operation and Calibration of Sievers 820 TOC Analyser

MICLAB-025 Depyrogenation of Glassware in Microbiology Laboratory Oven

EHS-100 Personal Protective Equipments (PPE) policy

EHS-050 Environmental Management System Plan

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

EHS-125 Selection of Personal Protective Equipments (PPE)

EHS-070 Hazard Identification and Incident Investigation Reports

EHS-110 Laboraotry Spill Response

EHS-115 Process Safety

EHS-075 First Aid Procedure

EHS-040 Blood Borne Pathogen Exposure

EHS-080 Industrial Hygiene Sampling for Airborne Contaminants

EHS-035 Blood and Body Fluid Spill Management

EHS-060 Fire Protection Impairment Handling

EHS-065 Hot Work Permit Procedure

EHS-055 Environmental Aspect Register

EHS-090 Occupational Medical Support Procedure

EHS-120 Industrial Hygiene Sampling

WAR-080 Raw Material Tablet Sampling by Dispensary

EHS-105 Environmental Health and Safety Training

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