Sterile Compounding Standard Operating Procedur e Templates

Sterile Compounding Standard Operating Procedure Templates

Table of Contents

Section

Name of Standard Operating Procedure/Form

Section 1

Facility and Personnel Specifications

General Requirements

Good Pharmacy Documentation Practices

Document Number SOP-102

SOP-104

? Signature Log Developing Standard Operating Procedures, Forms and an Effective Change Control System ? Master Table of Contents

F-104.a SOP-106 F-106.a

? SOP Template

F-106.b

? Vertical Form Template

F-106.c

? Horizontal Form Template

F-106.d

? SOP/Form Change Request Template

F-106.e

Inspections and Communications with External Agencies

SOP-108

? Inspection Guide and Inspection Report

F-108.a

General Facility and Pharmacy Pest Control

SOP-110

Section 2 Facility and Personnel

Monitoring

Management and Oversight of Outsourced Services

Quality Management Considerations in Environmental Monitoring and Personnel Sampling ? Sample Environmental Viable Sampling Plan Diagram

SOP-112 SOP-204 F-204.a

Viable Air Sampling

SOP-200

? Viable Air Sampling Log

F-200.a

Surface Sampling

SOP-202

? Surface Sampling Log

Airflow Considerations and Pressure Differential Monitoring ? Pressure Differential Log

Temperature and Humidity Monitoring in Compounding and Controlled Storage Areas ? Temperature and Humidity Monitoring Log

F-202.a SOP-208 F-208.a SOP-210 F-210.a

? Temperature and Humidity Correction Action Log

F-210.b

Incubation and Inspection of Solid and Liquid Media for Microbial Growth

SOP-212

Investigation and Remediation in the Event Sampling Exceeds Alert or Action Levels

SOP-205

?1997-2020 CriticalPoint, LLC and its affiliates - All rights reserved

Page 1 of 5; F-106.a; 10/28/19

Sterile Compounding Standard Operating Procedure Templates

Table of Contents

Section

Name of Standard Operating Procedure/Form

Section 2 Facility and Personnel

Monitoring

Section 3 Sterile Compounding Facility Management

? Facility and Personnel Sampling Action Report

? Matrix of Actions for First OOL Occurrence ? Matric of Actions for Consecutive and Repeat OOL

Occurrence Facility Management Overview Certification and Preventative Maintenance of Controlled Environments and Related Equipment ? Prefilter Maintenance Log

Document Number F-205.a F-205.b

F-025.c

SOP-300 SOP-302 F-302.a

Total Particle Count Testing

Sanitization of the Controlled Sterile Compounding Environments ? Cleaning Solution Preparation Log for Agents

Requiring Dilution ? Daily/Monthly Cleaning Log for Controlled

Compounding Sterile Compounding Environments and Adjacent Areas ? Three-Time Cleaning Log for Sterile Compounding Controlled Environments ? Job Aid: Daily and Monthly Sanitization of Nonhazardous Sterile Compounding Environments

Material Handling

SOP-303 SOP-304 F-304.a

F-304.b

F-304.c F-304.d SOP-305

Section 4 Training, Conduct and Competency of Sterile

Compounding Personnel

Maintenance and Use of RABS (CAIs and CACIs)

Actions in the Event of Unexpected or Planned Power Loss in a Sterile Compounding Facility

? Facility Power Up Log

Hand Hygiene and Garbing for Nonhazardous Sterile to Sterile Compounding ? Job Aid: Steps for Best Practice Garbing for Sterile to

Sterile Nonhazardous Garbing Sink on Clean Side of Ante-room ? Job Aid: Steps for Best Practice Garbing for Sterile to Sterile Nonhazardous Garbing Sink on Dirty Side of Ante-room ? Job Aid: Steps for Best Practice Garbing for Sterile to Sterile Nonhazardous Garbing Sink Outside Anteroom in Adjacent Space ? Job Aid: Steps for Best Practice Garbing for Sterile to Sterile Nonhazardous Garbing in Segregated

SOP-306 SOP-308 F-308.a SOP-404 F-404.a

F-404.b

F-404.c F-404.d

?1997-2020 CriticalPoint, LLC and its affiliates - All rights reserved

Page 2 of 5; F-106.a; 10/28/19

Sterile Compounding Standard Operating Procedure Templates

Table of Contents

Section

Section 4 Training, Conduct and Competency of Sterile

Compounding Personnel

Name of Standard Operating Procedure/Form

Compounding Area (SCA) with Sink in SCA Outside Perimeter Line ? Job Aid: Steps for Best Practice Garbing for Sterile to Sterile Nonhazardous Garbing in Segregated Compounding Area (SCA) with Sink Outside of an SCA that is a separate room Orientation, Training and Competency Evaluation of Compounding Personnel

? Training Roster

? Competency Assessment: Hand Hygiene and Garbing for Nonhazardous Sterile Compounding Sink on Clean Side of Ante-room

? Competency Assessment: Hand Hygiene and Garbing for Nonhazardous Sterile Compounding Sink on Dirty Side of Ante-room

? Competency Assessment: Hand Hygiene and Garbing for Nonhazardous Sterile Compounding Sink Outside Ante-room in Adjacent Space

? Competency Assessment: Hand Hygiene and Garbing for Nonhazardous Sterile Compounding in Segregated Compounding Area (SCA) with Sink in SCA Outside Perimeter Line

? Competency Assessment: Hand Hygiene and Garbing for Nonhazardous Sterile Compounding in Segregated Compounding Area (SCA) with Sink Outside of SCA that is a Separate Room

? Competency Assessment: Aseptic Technique

? Competency Assessment: Sanitization of Nonhazardous Sterile Compounding Areas

? Competency Assessment: Material Handling

Document Number

F-404.e SOP-410 F-410.d F-410.a F-410.r F-410.s

F-410.t

F-410.u F-410.b F-410.c F-410.e

? Competency Assessment: Environmental Sampling

F-410.f

? Competency Assessment: Secondary Engineering Controls

F-410.g

? Competency Assessment: Use of Biological Safety Cabinets (BSCs)

F-410.h

? Competency Assessment: Use of Restricted Access Barrier Systems (RABS) (CAIs and CACIs)

F-410.i

? Competency Assessment: Use of Laminar Airflow Workbenches(LAFWs)

F-410.j

? Competency Assessment: Final Release Tests (Sterility Testing - Membrane Filtration) Retired 10/28/19

F-410.k

?1997-2020 CriticalPoint, LLC and its affiliates - All rights reserved

Page 3 of 5; F-106.a; 10/28/19

Sterile Compounding Standard Operating Procedure Templates

Table of Contents

Section

Section 4 Training, Conduct and Competency of Sterile

Compounding Personnel

Name of Standard Operating Procedure/Form

? Competency Assessment: Final Release Tests (Pyrogen Testing) Retired 10/28/19

? Competency Assessment: Filter Integrity Testing (Bubble Point Test)

? Competency Assessment: Automated Compounding Devices and IV Work Flow Devices

? Competency Assessment: Assigned and Authorized Evaluator

? Competency Assessment: Reading Liquid and Solid Media for Contamination

? Competency Assessment: Use of Non Compounding Equipment

Gloved Fingertip Sampling

Document Number F-410.l F-410.m F-410.n F-410.o F-410.p F-410.q SOP-408

? Job Aid: Personnel Sampling

Personnel Aseptic Media-Fill Testing and Process Verification ? Personnel Sampling Log

F-408.a SOP-402 F-402.a

Section 5 Component Inventory

and CSP Handling

Section 6 General Sterile Compounding Process

? Process Verification Sampling Log Conduct of Personnel in Compounding Areas and Aseptic Technique Overview Inventory Storage, Handling and Disposal Procedure

? Component Disposal Log CSP Handling, Storing, Packaging, Shipping, and Transporting ? CSP Delivery Verification Form

CSP Stability and Assignment of Beyond Use Dating ? CSP Stability and Beyond Use Dating Documentation

Form Documentation of Compounding

F-402.b SOP-412 SOP-502 F-502.a SOP-508 F-508.a SOP-602 F-602.a SOP-603

Use of Conventionally Manufactured Products and CSPs

SOP-604

Use of Compounding Related Equipment

SOP-605

Non-Automated Pooling Processes

SOP-606

Elastomeric Compounding

SOP-608

CSP Labeling

SOP-610

Considerations for Nonsterile to Sterile Compounding

SOP-612

?1997-2020 CriticalPoint, LLC and its affiliates - All rights reserved

Page 4 of 5; F-106.a; 10/28/19

Sterile Compounding Standard Operating Procedure Templates

Table of Contents

Section

Name of Standard Operating Procedure/Form Visual Inspection of Compounded Medications

Document Number

SOP-614

Section 7 Hazardous Drug Compounding

Hazardous Drug Employee Training and Safety Program ? Hazardous Drug Acknowledgement of Risk ? HD Inventory and Receiving Competency

SOP-700 F-700.a F-700.b

? Donning and Doffing HD PPE Competency

F-700.c

? HD Compounding Competency ? HD Decontamination, Cleaning and Disinfection

Competency ? HD Spill Management Competency

F-700.d F-700.e F-700.f

Section 8 Quality Management

? HD Assessment of Risk Template

Hazardous Drug Handling, Receiving, Storage, Labeling Packaging and Transport Hazardous Drug Garbing and Compounding Techniques Hazardous Drug Decontamination Spill and Waste Management ? Hazardous Drug Spill Report Form Template

Quality Management Program for Facilities Compounding Sterile Preparations ? Corrective and Preventitive Action Plan Form

F-700.g SOP-702 SOP-704 SOP-706 F-706.a SOP-802 F-802.a

Handling Customer Complaints

SOP-804

? Customer Complaint Form

F-804.a

Reporting Adverse Events

SOP-806

Recalls and Quarantine

SOP-808

?1997-2020 CriticalPoint, LLC and its affiliates - All rights reserved

Page 5 of 5; F-106.a; 10/28/19

 ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download