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Standard Operating Procedures for Validation and Compliance

FDA requires various routine activities to follow written procedures. Healthcare professionals typically use Standard Operating Procedures (SOPs) to address this.
146 example SOPs from Labcompliance help to develop and maintain your own SOPs.
They help you to comply with FDA and equivalent international regulations: GLP, GCP, GMP, Part11/Annex 11, PIC/S, ISO 17025


Currently
172 SOPs are available for:

Pricing

  1. US$ 49.- for single SOP in PDF format.
  2. US$ 69.- for single SOP in MS Word™ format for easy editing.
  3. US$ 349.- for package of 10 in PDF format.
  4. US$ 399.- for package of 10 in MS Word™ format

Ordering

  1. Select one or more SOPs
  2. Check the box related to the SOP(s)
  3. Select the format (PDF or MS Word™)
  4. Complete the form with your name, address, method of payment etc

On December 1, 2014, we added 14 new SOPs

  • Going from GLP to GMP (S-120-01)
  • Going from GMP to GLP (120-02)
  • Elemental Impurity Control According to ICH Q3D (S-416)
  • Assessment Process for Potential Genotoxic Impurities (420)
  • Handling Deviations from Threshold of Toxicological Concern (TTC) (421)
  • Setting up a Quality System for Pharmaceutical Testing Laboratories (503)
  • Review of Analytical Methods and Procedures (605-02)
  • Development and Validation of Analytical Methods through Quality by Design )S-609)
  • Calibration and Qualification of SFCs (S-650)
  • Performance Testing of SFCs (S-651)

SOPs market with * are new additions

   

Management and Procedures
S-104 Generation and Maintenance of SOPs
S-105 Document Management and Control
S-106 Handling Deviations from Standard Operating Procedures
S-107 Writing and Distribution of Electronic SOPs
S-108 Internal Audits - Preparation, Conduct, Follow-up
S-109 Internal Audits for Part 111 Compliance
Preparation – Conduct – Follow-up
S-111 Conducting Management Reviews
 S-114 Corrective and Preventive Actions
S-115 Handling Out-of-Specification Results
S-116 Handling Out-of-Trend Situations
S-117 Out-of-Specification Data Trending
S-118 Investigating Manufacturing Incidents
S-120_01 Going from GLP to GMP
S-120_02  *Going from GMP to GLP
S-121 GLP Facilities and Environmental Control
S-123 Training for GLP Compliance
S-124 Training for GMP Compliance
S-125 Training for GxP, 21 CFR Part 11 and Computer Validation
S-126 Building a GMP System for International Environments
S-128 Auditing Suppliers
S-134 Risk Assessment for Systems Used in GxP Environments
S-137 21 CFR Part 11 - Scope and Controls
S-141 FDA Inspections – Preparation, Conduct, Follow up
S-142 International GMP Inspections – Preparation, Conduct, Follow up
S-143 Responding to 483 Inspectional Observations
S-144 Responding to FDA Warning Letters
S-145 Requirements, Responsibilities and Tasks of the Qualified Person
Good Laboratory/Clinical/Manufacturing Practice Regulations
S-148 Reporting and Handling of GLP Study Deviations
S-149 Recording of GLP Raw Data
S-150 Historical SOP File for GLP Regulation
S-151 Archiving GLP Data and Other Documents
 S-161 Recording of GMP Raw Data
S-162 Archiving of GMP Data and Other Documents
S-163 Recording of GCP Source Data
S-164 Archiving and Retrieval of GCP Data and Other Documents
S-165 Responsibilities of Sponsors and Clinical Sites for Computerized Systems
Qualification and Validation
S-231-01 Auditing a Supplier’s Equipment Master Validation Plan
S-236 Supplier Assessment According to ASTM E2500
S-237 Development and Maintenance of Test Scripts for Equipment Hardware, Software and Systems
S-238 Handling Deviations during Equipment and Computer System Testing
S-239 Equipment and System Verification According to ASTM E2500
S-240 Qualification of Equipment
S-241 Maintenance of Equipment
S-242 Change Control of Equipment
S-244 Requalification of Equipment
S-246 Development of User Requirement Specifications for Equipment
S-248 Testing File Integrity of E-Mail Attachments
S-249 Developing a Gap Analysis for Software and Computer System Validation
S-251_01 Developing an effective Supplier Program to Assists Regulated Users
S-251_02 *Selecting the Right Software and Equipment Supplier for Compliance
S-252 Risk Based Validation of Computer Systems
S-253 Development of Requirement Specifications for Computer Systems
S-258 Periodic Evaluation and Review of Computerized Systems
S-259 Configuration Management and Version Control of Software
S-260 Revalidation of Software and Computer Systems
S-261 Retirement of Computer Systems
S-262 Change Control of Software and Computer systems
S-263 Validation of Macro Programs and Other Application Software
S-264 Validation Of Spreadsheet Applications
S-265 Using Macros and Spreadsheets in a Regulated Environment
S-266 Development and Use of Spreadsheets in Part 11 and GxP Environments
S-267 Validation of Electronic Laboratory Notebooks
S-268 Using Electronic Laboratory Notebooks in an FDA Regulated Environment
S-269 Retrospective Validation of Computerized Systems
S-270 Validation of Electronic Document Management Systems
S-271 Validation of Commercial Off-the-shelf (COTS) Computer Systems
S-272 Auditing Computer Systems
S-273 Auditing Software Suppliers: Preparation, Conduct, Follow-up
S-274 Quality Assessment of Software and Computer System Suppliers
S-277 Responsibilities for Computer System Validation
S-283 Change Control for Networks and Systems - Planned Changes
S-284 Change Control for Networks and Systems - Unplanned Changes
S-285 Risk Based Qualification of Network Infrastructure
S-286 Validation of Web-Based Applications
S-287 Using the Internet in Regulated Environments
S-288 Handling Security Patches
S-289 Qualification of PC Clients
S-290 Qualification of Data Centers
S-291 Qualification of Servers
S-292 *Qualification of Virtual Networks
S-293  *Using Cloud Computing in Regulated Environments
Electronic Records Management
S-315 Retention and Archiving of Electronic Records
S-316 Scanning of Paper Records for GxP Compliant Archiving
S-317 Data Back up and Restore
S-318 Handling Contingency Situations for Computer Systems
S-319 Disaster Recovery of Computer Systems
S-320 Access Rights to Computer Systems and Data
S-322 Electronic Audit Trail
Specifications, Implementation and Validation
S-323 *Review of Electronic Audit Trail
S-324 *Integrity and Security of Electronic Records
S-325 *Using Electronic Signatures in Regulated Environments
General Laboratory Compliance
S-411 Stability Testing of Drug Products
S-412 Stability Testing of Drug Substances
S-416 *Elemental Impurity Control According to ICH Q3D
S-420 Assessment Process for Potential Genotoxic Impurities
S-421 Handling Deviations from Threshold of Toxicological Concern (TTC)
S-503 Setting up a Quality System for Pharmaceutical Testing Laboratories
S-504 Generation and Maintenance of SOPs for Laboratories
S-507 Internal Audits for ISO 17025
S-508 Gap Analysis for ISO 17025
S-509 Change Control of Analytical Equipment
S-510 Conducting Laboratory Management Reviews
S-511 Auditing Analytical Laboratories
S-511_02 *Auditing Laboratories for ISO 17025 Compliance
S-511-03 Auditing Quality Control Laboratories
S-512 Review and Approval of Analytical Test Results
S-513 Training for Laboratory Personnel
S-514 Purchasing and Receipt of Supplies for Laboratories
S-514_02 *Purchasing of Services for Laboratories
S-515 Quality Assessment of Laboratory Suppliers
S-515_02 *Quality Assessment of Laboratory Service Providers
S-516 Auditing Suppliers of Laboratory Supplies
S-519 Risk Assessment for Laboratory Systems
S-520 Laboratory Complaint Handling
S-520_01 *Laboratory Complaint Handling for ISO 17025
S-520_11 *Improving the Effectiveness of the Laboratory Management System
S-520_16 *Laboratory Facilities and Environmental Control
S-521 Review of Requests, Tenders and Contracts
S-522 Subcontracting of Testing and Calibration
S-524  Providing Services to Customers
S-525 Control of Non-Conforming Testing and/or Calibration Work
S-526 Identification and Control of Laboratory Records
S-527 Recording and Archiving of Records for ISO 17025
S-530 Laboratory Failure Investigations
S-531 Sampling for Analytical Testing
S-532 Preparation of Laboratory Working Standards
S-534 Handling of Laboratory Test Samples
S-535 Reserve Samples in Laboratories
S-536 Measurement Uncertainty in Chemical Analysis 
S-537 Measurement Traceability in Chemical Analysis 
S-541 Maintenance of Laboratory Equipment
Qualification/Validation in Laboratories
S-605 *Selection of Analytical Methods and Procedures
S-605_02 Review of Analytical Methods and Procedures
S-609 Development and Validation of Analytical Methods through Quality by Design
S-610 Bioanalytical Method Validation
S-611 Validation of HPLC Methods
S-612 Validation of Analytical Methods
S-613 Validation of Chromatographic Methods
S-614 Transfer of Analytical Methods
S-615 Verification of Compendial Methods
S-617 Change versus Adjustment of Compendial Methods
S-618 Change versus Adjustment of Analytical Methods
S-619 Validation of Stability Indicating Methods
S-620 Validation of Analytical Methods for Elemental Impurities
S-621  On-going Performance Control of Analytical Equipment
S-622 System Suitability Testing in Chromatography
S-623 Verification of Standard Methods
S-625 Handling (Certified) Reference Material
S-628 Development of User Requirement Specifications for Analytical Equipment
S-629 Allocating Analytical Instruments to USP <1058> Categories
S-630 Procedures and Deliverables for Qualification of USP <1058> Instrument Categories
S-631 Analytical Instrument Qualification According
to USP <1058>
S-632 Qualification of Analytical Equipment
S-633 Requalification of Analytical Equipment
S-635 Developing and Maintenance of Test Scripts for Analytical Systems
S-641 Calibration of Analytical Balances
S-644 Qualification of Refrigerators
S-648 Calibration and Qualification of HPLCs
S-649 Performance Testing of HPLCs
S-650 Calibration and Qualification of SFCs
S-651 Performance Testing of SFCs
S-652 Calibration and Qualification of Stability Chambers
S-653 Performance Testing of Stability Chambers
S-656 Validation of Laboratory Computer Systems
S-662 Risk Based Validation of Laboratory Computer Systems
S-663 Risk Based Validation of Laboratory Computer Systems
S-672 Reporting Analytical Data for FDA and ISO 17025 Compliance
S-690 Validation of Software and Computer Systems for ISO 17025
S-691 Using Software and Computer Systems for ISO 17025
Qualification/Validation in Manufacturing
S-915 Installation Qualification Protocol for Manufacturing Equipment
S-916 Operational Qualification Protocol for Manufacturing Equipment
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Pricing

  1. US$ 49.- for single SOP in PDF format.
  2. US$ 69.- for single SOP in MS Word™ format for easy editing.
  3. US$ 349.- for package of 10 in PDF format.
  4. US$ 399.- for package of 10 in MS Word™ forma

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LabCompliance Mail Order
Christoph Huber
Obere Alm 27
77704 Oberkirch
Germany