Scientist-At-Work: SOP's For Pharma Industry(Source:http://www.gmpqualityup.com)

GMP Quality Guidance

Product Quality Complaint Handling

Application of Quality Risk Management to Periodic Review of SOPs

Statistical Rationale for Raw Material Sampling

Quality Risk Management Application Critical Instrument Calibration

Structured On-the-Job Training System

Training system for Aseptic and Preparation for Aseptic Operators and Support Staff

Disposal of Rejected and Waste Materials

Quality Assurance Self-Appraisals

Material Status Indication

Annual Product Records Review

Receipt, Approval and Use of Labels and Labeling

Weighing and Measuring Practices In Manufacturing Operations

Material Supplier Approval

Storage & Distribution of Drug Products, Medical Devices and Related Materials

Control of Manufacturing and Packaging Defects Non Sterile

Pest Control

Raw Materials and Packaging Materials Receipt

Sampling of Production Materials and Finished Goods

Water Purification, Storage and Distribution For Pharmaceutical Production

Use of a Risk-Based Approach To Establish External Quality Assurance Audit Frequency

Reduced Testing Program

GMP Training System

Stability Testing

Quality Risk Management Application to Identify Deviations vs. Events

Implementation of Real Time Release

Preventive Maintenance

Calibration

Evaluation Process Supporting Elimination of Defined Shipment Temperature Range

Determining Testing Patterns and Acceptance Criteria for Analytical Method Transfers

Quality Risk Management to Establishment of Weighing Device Performance Testing Intervals

Analytical Laboratory Management

Microbiology Laboratory Management

Transfer of Analytical Methods

Quality Agreements

Aseptic Processing Area Guidance

Alternatives to Formaldehyde Fogging of Clean Rooms

Clean Steam Systems

Cleaning and Sterilization of Aseptic Manufacturing Equipment

Container Closure Integrity for Sterile Drug Products

Controlling the Microbiological Quality of Solid Oral Dosage Forms

Defining Worst Case Conditions for Aseptic Process Simulations

Explanation of Repeat Testing and Retesting Utilized During Microbiological OOS Investigations

Gamma Radiation Sterilization

Lyophilization

Lyophilizer Loading and Unloading Recommendations

Microbial Attributes Testing of Non-Sterile Solid Oral Dosage Forms and Materials

Microbiological Testing in Cleaning Validation for APIs and Drug Products

Packaging System Integrity for Sterile Medical Devices

Preventing Cross Contamination

Prevention and Control of Fungal Contamination in Tablets

Sanitant Rotation in a Routine Sanitization Program

Sterilization or Depyrogenation Validation - Non Product

Unplanned Cleanroom Power Outage Time Limit and Recovery Determinations for Aseptic Processing Areas

Use of Sterilized Goggles Within the Aseptic Processing Area

Water Activity - What Is It and How Does It Apply To Pharmaceutical Manufacturing

Good Working Practice

Good Practice - Facilities and Equipments

Equipment Cleaning for Drug Products

Identification of Equipment Areas and Processes

Equipment Cleaning for Active Pharmaceutical Ingredients (APIs)

Calibration

Preventative Maintenance

Cleaning and Sterilization of Aseptic Manufacturing Equipment

Areas and Facilities Cleaning and Maintenance

Pest Control

Water Purification, Storage, and Distribution for Pharmaceutical Production

Air Handling Systems & Air Classifications for Aseptic Operations

Clean Steam Systems

Aseptic Area Environmental Control

Good Practice - Materials

Reevaluation of Stored Materials

Disposal of rejected and waste material

Material Status Indication

Material Supplier Approval

Raw Materials and Packaging Materials - Receipt

Sampling of Production Materials and Finished Goods

Storage and Distribution of Drug Products, Medical Devices, and Related Materials

Subdividing Dispensing & Transferring Materials to Production Areas

Quarantine Shipment

Good Practice - Labeling and Packaging

Instructions for Filling, Labeling and Packaging Pharmaceutical Drug Products and API's for Commercial Purposes

Creation, Revision, and Approval for Artwork Used on Packaging Components

Receipt, Approval, and Use of Labels and Labeling

Container Closure Integrity for Sterile Drug Products

Packaging System Integrity for Sterile Medical Devices

Good Practice - Operations

Inspecting for Manufacturing and Packaging Defects-Aseptic

Instructions for Manufacture of APIs and Drug Products

Uniform Practices for Manufacturing Operations

Personnel Qualification Program for Aseptic Processing Areas and Preparation for Aseptic Areas

Aseptic Processing Facility Environmental Monitoring

Use and Recovery of Solvents in API Manufacturing

Metal Detection

Weighing and Measuring Practices in Manufacturing Operations

Gamma Radiation Sterilization

Preventing Cross Contamination

Control of Manufacturing and Packaging Defects Non-Sterile

Sterilization/Depyrogenation Validation: Non-Product

Gowning Practices for Aseptic Processing Areas and Preparation for Aseptic Areas

Cleaning Depyrogenation and Sterilization of Containers and Closures

Sterilizing Filters and Filtration Systems

Moist Heat Terminal Sterilization of Aqueous Parenteral Products

Media Fills for Sterile Drug Products and Aseptically Processed Medical Devices

Batch and Lot Identification

Aseptic Manufacturing Practices

GMP Quality Assurance and Compliance Procedures

How to Write Standard Operating Procedure

All Documents - Classification, Definition and Approval Matrix

GMP Quality Documentation Management and Change Control

Documentation Rule for GMP Documents

GMP Quality Documentation - Control, Tracking and Distribution

Preparation, Maintenance and Change Control of Master Documents

Pharmaceutical Deviation Report System

Shelf Life of Product

Vendor Selection and Evaluation Procedure

Vendor Certification Procedure

Pharmaceutical Product Complaint Procedure

Annual Product Review

Manufacturing Rework Procedure

Responsibility of Authorized Person

Procedure for Product Identification and Traceability

GMP Audit Procedures

Example of Checklist for Batch Documentation

Evaluation of Batch Documentation and Release for Sale

GMP Training Procedure

How to Write GMP Training Materials

House Keeping Audit Procedure

Management and Control of Contract Work

Criteria for Sourcing of Raw Materials, Critical Packaging Components and Imported Finished Goods

Quality Concern Investigation Process

Pharmaceutical Audit Training Manuals

Auditing Principles for GMP Audit

Understanding Worldwide Regulatory Requirements

Auditing a Personnel & Training System

Auditing a Deviation Management System

Auditing a Validation System

Auditing a Change Management System

Auditing a Complaint System

Auditing a Documentation System

Auditing a Calibration, Preventative Maintenance & Housekeeping System

Auditing Computerised Systems

Auditing Utilities System

Auditing Warehouse and Distribution System

Auditing Environmental Monitoring System

Auditing Microbiology and Sterility Testing Laboratory

Auditing an Analytical Quality & Stability Testing Laboratory

Auditing a Material Handling System

Auditing an Active API Manufacturer

Auditing Packaging Material Vendors

Auditing a Packaging and Labeling Operation

Auditing an Aseptic Sterile Area

Auditing an Excipient Supplier

Auditing an Oral Solid Solution Area

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

Cleaning Validation Interim Report Template

Cleaning Validation Campaign Length Increase Protocol

Cleaning Validation Protocol Template

Cleaning Validation Report Template

Installation and Operational Qualification Protocol Template

Installation and Operational Qualification Report Template

Packaging Validation Protocol Template

Packaging Validation Report Template

Process Validation Protocol template

Process Validation Report Template

Product Transfer Protocol Template

Electronic Records and Signatures Compliance Assessment

Impact Assessment Template for Equipment, Utility and Computer

Quality Control Analytical Laboratory Procedures

Retest Dating of Raw Materials

Calibration Policies for Laboratory Instruments

Archiving Laboratory Documentation

Management of Reference Substances

Laboratory Workbook

Creation of Certificate of Analysis

Managing Analytical Reagents

Laboratory Waste Management

Retention Samples Management in Laboratory

Laboratory Supplier Approval

Laboratory Results Out of Specification Investigation

Laboratory Testing and Documentation of Raw Materials

Laboratory Testing and Documentation of Finished Products

Preparation and Maintenance of Stability Protocols for pharmaceuticals Products

Stability and Trial Testing Procedure for pharmaceuticals Products

Microbiology Laboratory|Sterility Testing Procedures

Entry Procedure for Sterile Filling Areas

Validation of Aseptic Gowning Procedures

Microbiological Data Recording Procedure

Destruction of Biological Waste in Microbiology Laboratory

Depyrogenation of Glassware in Microbiology Laboratory Oven

Media Preparation in Microbiology Laboratory

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

Aseptic Media Filling and Soup Test Guideline

Environmental and Plant Hygiene Monitoring Procedure

Microbiological Monitoring of Plant Water Systems

Micro Laboratory Procedure for Sterility Testing

Determination of Heat Resistance of Spore Forming Organisms

Identification of Microorganisms to Genus and Species Level

Micro Evaluation on Bioburden, Non sterile and Raw Materials

Bacterial EndoToxin Testing (LAL) - Gel Clot Method

Bacterial EndoToxin Testing kCA Method

Stock Suspensions of Micro Organisms

Sterile Sampling Procedure for Microbiology Laboratory

Gel Clot Validation Method

Laboratory Investigation and Retest Procedure for Atypical and Out of Specification Results

Operation and Calibration of Sievers 820 TOC Analyser

GMP Manufacturing Procedures for Tablet Packing

Clothing Requirements Inside the Factory Area

Cleaning Responsibilities and Methods for Employees

Factory Cleaning Procedure

Manufacturing Pest Control Procedure

Tours of Factory

Management of Production Logbook

Examples of Packaging Configuration for Production Line

Checking Requirements of Components Prior to Use

Safety Tag Out Procedure

Procedures for Line Clearance, Line Opening and Line Cleaning

Reconciliation Procedure of Component and Product

Example-IBC Operation and Cleaning

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

Example of Manufacturing Instruction for Tablet Packing

Mop Cleaning Procedure

Scheduling of Production Lines

Vacuum Leak Testing Procedure forFinished Goods

Weighing Equipment - Checking and Calibration

Example of Operation of automatic Checkweigher for Finished Packs

Machine Start up Challenges and In-Process Testing Procedures

Finished Pack Sampling by Production Personnel

Warehouse Management Procedures

Generation of Purchase Order For Inventory and Consumables

Procedure for Receipt of Incoming Goods

Incoming Raw Materials and Components-Handling by QC Sampler

Warehouse Processing Issues, Returns and Rejects

Dispatch of Goods From Warehouse

Warehouse Inventory Management Procedure

Design of Warehouse Locations and Storage Area

Finished Goods Transfer to Quarantine and Distribution Warehouse

Sampling Procedure of Raw Materials

Sampling of Components and Printed Materials

Work in progress (WIP) Area

Safety Procedure of Warehouse Racking

Forklift Operation in Warehouse

Example of Tablet Dispensary Procedure

Example of Tablet Sampling Procedure as Raw Material

Environmental Health and Safety Procedures

Hazardous Chemical Substance Management

Environmental, Health and Safety Risk Management

Waste Removal Process

Identifying EHS Issues

EHS Incident Management Procedure

First Aid Procedure

GMP Manufacturing & Quality Assurance Manuals

Quality Assurance Manuals

Evaluation of Contaminant Options for Packing of Solid Dosage Forms

Retention and Disposal of GMP Documents and Retention Samples

Certificate of Materials Supplied to Receiving Manufacturing Site

Quality Assurance Agreements

Procedure for Quality Assurance Management of Contractors

Guidelines for Regulatory Inspections

Quality and Compliance Auditing

Auditor Training

Facility Based R&D Quality Assurance Audit

GMP Compliance Improvements Plans

Archiving, Disposal and Record Management

Internal Quality Assurance Agreements

Audit of a Distribution Site

Supplier Auditing

Management of Master GMP Document

Artwork Creation & Control of Printed Packaging Components

Release of API Bulk Formulated Products & Part Finished Packs

Computerized Systems Risk Management

Batch Confirmation Certification & Release by a Qualified Person within the EU

Cross Contamination Risk Evaluation Process for Commercial Compounds

Certificate of Analysis & Certificate of Manufacture

Pharmaceutical Product Reviews

Warehousing and Distribution of Commercial Products

Utility Standards

Conducting Investigations

Management and Documentation of Training

Definition and Documentation of Raw Data

Risk Management in the Quality Assurance and Compliance Area

Manufacturing Deviation Management

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

Guidelines for Generating Manufacturing Documentations

Electronic Records and Electronic Signatures

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

Management of Change in Computerised System

Access by Regulatory Authorities and Auditors to Electronic Records

Technology Transfer of Established Medicine from One Commercial Site to Other

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

Out of Specifications Results Investigation Procedure

Analytical Procedures and Validation

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

Retreatment and Blending of API and Formulated Products

Quality Assurance Templates

Raw Material Specification and Test Report Template

Internal Audit Report Template

Training Report Template

Form Template

SOP Template

Quality Assurance Agreement Template

Third Party Manufacture Dispatch Report Template

In-House Manual Template

Protocol Rework- Manufactured Finished Goods

Vendor Audit Report Template

Protocol Rework- In Process Manufactured Goods

Position Paper Template

Control Method Template

Formulation Template

Finished Product Specification and Test Report Template

Packaging Material Specification and Test Report

Bill of Materials Template

GMP Links

US Food and Drug Administration

International Conference on Harmonization

The Pharmaceutical Inspection Convention

American Association of Pharmaceutical Scientist

Drug Information Association

European Medicines Agency

European GMP Guide

International Federation for Animal Health

National Institute of Health USA (NIH)

National Library of Medicine USA

World Health Organization (GMP Production)

MHRA

Japan Medical Association

Australian Therapeutic Goods Administration

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

GMP Validation Guidance

Method Validation

Analytical Test Method Validation - General Guidence

Analytical Test Method Validation - Risk Assessment and Prioritization

Analytical Test Method Validation - System Suitability

Analytical Test Method Validation - Precision and Accuracy

Analytical Test Method Validation - Quantitation and Detection Limit

Analytical Test Method Validation - Linearity, Range and Specificity

Analytical Test Method Validation - Robustness

Cleaning Validation

Cleaning Validation - Calculations of Residue Limits For Drug Products for Equipment Cleaning

Cleaning Validation - Product and Equipment Grouping and Worst - Case Product Selection

Cleaning Validation – Rinsate and Swab Sample,Test Method Development and Validation

Cleaning Validation – Visual Inspection and Quantitation

Cleaning Verification – Investigating Unknown Peaks in Chromatography

Cleaning Evaluation Documentation and Instruction - Records for Cleaning Activities

Critical Process Parameters for Drug Product

Other Validation

Process Validation for Drug Products and Medical Devices

Equipment Cleaning Validation For Active Pharmaceutical Ingredients

Equivalence Criteria of Impurities for API Process Validation

Equivalency Comparison of Drug Product Validation Batch Data to Reference Batches

Establishing and Extending Clean Equipment Hold Times

Evaluating Non-Cleaned Equipment Hold Times for Cleaning Validation of APIs and Drug Products

Evaluation of Changes for Potential Impact on Process Validation

General Guidance for Process Validation Sampling

In-Process and Bulk Drug Product Holding Times

Demonstration of Active Pharmaceutical Ingredient (API) Batch Homogeneity

Documentation Example for Continuous Quality Verification

Scientist-At-Work

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SOP's For Pharma Industry(Source:http://www.gmpqualityup.com)