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 146 SOPs are available for:

• Management and Procedures  
• Good Laboratory/Good Manufacturing/Good Clinical Practices
• Qualification and Validation  
• Electronic Records Management  
• General Laboratory Compliance  
• Qualification/Validation in Laboratories  
• Qualification/Validation in Manufacturing

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

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-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

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

General Laboratory Compliance
S-411	Stability Testing of Drug Products
S-412	Stability Testing of Drug Substances
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-512	Review and Approval of Analytical Test Results
S-513	Training for Laboratory Personnel
S-514	Purchasing and Receipt of Supplies for Laboratories
S-515	Quality Assessment of Laboratory Suppliers
S-516	Auditing Suppliers of Laboratory Supplies
S-519	Risk Assessment for Laboratory Systems
S-520	Laboratory Complaint Handling
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-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-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-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

Order by mail

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LabCompliance Mail Order
Christoph Huber
Obere Alm 27
77704 Oberkirch
Germany