SUGGESTED  SOP  TITLES

 


Any titles may be semi-customized and ordered below.

STANDARD OPERATING PROCEDURES TABLE OF CONTENTS

0100-SERIES: GENERAL PROVISIONS

...101 Definitions: US FDA's 21 CFR Part 820 -- Q S Regulation

0200-SERIES: QUALITY SYSTEM REQUIREMENTS

...201 Quality Policy

...202 Company Organization [available as a custom written SOP only]

...203 Internal Quality System Audit Program

...204 Outside Regulatory Audit Policy / Procedures

...205 Personnel & Training

0300-SERIES: DESIGN CONTROLS

...301 Project Management, New Product Development, Design Control, and the DHF

...302 Verification and Validations (V & V) Protocols

...303 Lab Notebooks

...304 Product Hazard / Risk Analysis

...305 Software V&V - Risk Based

0400-SERIES: DOCUMENT CONTROLS

...401 Standard Operating Procedure (SOP) System

...402 Deviations & Change Orders (CO/ECO's)

0500-SERIES: PURCHASING CONTROLS

...501 Vendor Audit Program

...502 Supplier / Component Controls (and Continuing Guarantee)

0600-SERIES: IDENTIFICATION AND TRACEABILITY

...601 Lot and/or Serial Numbering System

...602 Line Clearance and Start-up Instructions

0700-SERIES: PRODUCTION AND PROCESS CONTROLS

...701 Component Assembly [available as a custom written SOP only]

...702 Final Assembly [available as a custom written SOP only]

...703 Calibration and 'NCI' Programs

...704 Tooling/Fixturing and Equipment Traceability/Control

...705 Facilities and Environmental Controls

...706 Personnel Cleanliness

...707 Equipment Maintenance Program

0800-SERIES: ACCEPTANCE ACTIVITIES

...801 Material/Component Receiving and Inspection

...802 In-process Inspection

...803 Final Inspection and Product Release

0900-SERIES: NONCONFORMING PRODUCT

...901 Non-Conforming Materials / Components

...902  Dispositioning    

...903 Rework / Reprocessing Procedure

...904 Product Recall Procedures

1000-SERIES: CORRECTIVE AND PREVENTATIVE ACTION

..1001 Data Trending

..1002 Corrective and Preventative Action (CAPA)

..1003 Complaints / MDR Reporting

..1004 Failure Investigation and Root Cause Analysis 

1100-SERIES: LABELING AND PACKAGING CONTROL

..1101 Labeling System

1200-SERIES: HANDLING, STORAGE, DISTRIBUTION AND INSTALLATIONt

..1201 Handling, Storage and Distribution Systems

..1202 Product Installation [available as a custom writen SOP only]

1300-SERIES: RECORDS

..1301 Device Master Record (DMR)

..1302 Device History Record (DHR)

..1303 Complaint/MDR Systems

1400-SERIES: SERVICING

..1401 Returned Goods Authorization (RGA) System

..1402 Servicing [available as a custom written SOP only]

1500-SERIES: STATISTICAL TECHNIQUES

..1501 Six-sigma Principles

..1502 Sampling Statistics

..1503 Control Charts -- X-bar and R


Compare our low costs...

These are simple, "bare bones", "no frills" SOPs which have passed several US FDA audits of small and mid-sized firms.  Some have been written for and reviewed / accepted by regulatory investigators of large multinational firms as well.

Suitable as a framework to which a company's unique requirements can readily be added by the user.

Include a minimal training component for "train-the-trainer".

Grouped per US FDA 21 CFR Part 820 (Medical Devices); 

also available on similar subjects for 21 CFR 210, 211 (Pharmaceuticals; and Dietary Supplements / Nutraceuticals)


Order a semi-customized SOP on any title listed above


SEMI-CUSTOMIZED SOPS:  

We adapt the desired SOP template(s) to your heading / format, 

and will make reasonable content adjustments for your existing systems. 

Unique SOPs, or complete customizations, are available as a consulting project.

Sent as an e-mail attachment (specify format, e.g., MS-Word, WP...);

and available in hard copy , or floppy or CD-ROM, at no additonal charge.

$199.00 each; sales tax (UT, if applicable) and S/H are included in price.

 

Enter SOP Number

ORDER THE COMPLETE SET OF GENERIC SOP TEMPLATES

(also available in semi-custom formats;  suitable for further customization 

to your specific requirements):

     Specify: 

        Series 1-6   (approx. 15 SOPs)                 $1990.00 (USD)

        Series 7-11  (approx. 15 SOPs)                 $1990.00 (USD)

        Series 12-15 and Quality Manual (approx. 8 and QM that references

            all above SOPs)                      $1990.00  (USD) (also includes on-line overview training on each SOP and a certificate)

Note:  Does not include company- / process- / product-specific or bracketed SOPs.  

Generic bracketed SOPs require some customization and are only available  at the single SOP price.  Ask for quotes on company- / product- / process-specific SOPs.

SOPs:

SPECIAL PROJECTS

Contact us about scope and pricing.

 

Types

Check out our SOP website at www.gmp-sops.com for more information about our service.

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                                                                                                                  Last updated on 06/20/2014.