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STANDARD OPERATING PROCEDURES
Manuals | Publication Order Form
A standard operating procedure (SOP) is a detailed set of instructions that inform an employee how
to perform a task.
SOPs are a cornerstone of compliance with ISO 9000 and an essential component of the proposed revised
GMP regulations.
CMA Inc has developed a comprehensive set of specific focused SOPs for the cleanrooom. This set
incorporates the current guidelines and standards.
WHY PURCHASE?
- Updated SOPs
- Audit against your internal SOPs
- Overlooked topics
- Lack of manpower to write SOPs
- Start-up facility
- Supply generic SOPs to a contract facility
WHO SHOULD PURCHASE?
- Medical Device Manufacturers
- Pharmaceutical Manufacturers
- Biotech Companies
- Contract Manufacturers
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STANDARD OPERATING PROCEDURES SETS
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MONITORING CMA-19
Air Monitoring
Airborne Particle Counting
Analytical Methods
External Influences
Fallout Plate
Monitoring Irregular Surfaces
Monitoring / Environmental
Power Failure
RCS Monitoring
Rodac Monitoring
Culture Media
Data Review & Action Plan
PRICE: $995.00
PERSONNELCMA-20
Gowning - Class 100
Gowning Class 10,000
Gowning Qualification
Gowning Monitoring
Employee Illness Policy
Training
PRICE: $500.00
VALIDATION CMA-21
Master Validation Plan
PRICE: $ 95.00
OPERATIONS CMA-22
Aseptic Technique
Equipment Maintenance
Equipment Transfer
Equipment Wipe Down
Machine Preparation
Material Transfer
Preventative Maintenance
Product & Material Flow
Safety Cabinets
Aseptic Operations
Tools - Admitting into Cleanrooms
PRICE: $ 750.00
CLEANING & SANITIZATION CMA-23
Cleaning & Disinfecting
Disinfectants
Fumigation
Hoods, Cleaning
Housekeeping Practices
Hoods, Sanitizing
Sanitizing Solutions
Support Area Housekeeping
Support Areas Cleaning
PRICE: $ 650.00
START- UP PROCEDURES CMA-24
Certification
Smoke Testing
Facility Start-up
Start-up RCS Monitoring
Start-up Rodac Testing
PRICE: $ 400.00
Complete Set : $ 2,500.00 CMA-25
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