Standard Operating Procedures

A series of SOP templates and a Quality Manual to help
you comply with the regulatory requirements
for Quality and Standard Operating Procedures.

 

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Complete Set
Quality Manual and complete set of SOPs

$2,497.00 Add to Cart
Quality Manual
The Quality Manual sets forth quality policies, objectives, and management responsibilities.
$197.00 Add to Cart

Master SOP
This SOP is written to document and define the formal procedure that     
personnel must follow when writing, reviewing, approving, training and   
implementing procedures.

$197.00 Add to Cart

Quality Unit Responsibilities
Details the responsibilities and activities carried out by a Quality representative.

$147.00  Add to Cart 
SOP Training
Defines the steps for training employees in SOPs. Includes appropriate forms.
$147.00 Add to Cart
GMP and Technical Training
Define and formalize the procedure for training employees under GMP requirements. Includes appropriate forms.
$147.00 Add to Cart
Personnel Responsibilities
Ensure that all personnel that may come in contact with a product, its component, or its environment are healthy, clean, and attired appropriately.
$147.00 Add to Cart
Change Control System
Define the process for reviewing a change to equipment, software and facilities to determine the impact of a change.
$147.00 Add to Cart
Deviations
Define the procedure for planned and unplanned deviations
$147.00 Add to Cart
Good Documentation Practice
Defines the record keeping requirements to ensure that accurate, neat and legible manufacturing records are maintained. 
$147.00 Add to Cart
Signature and Initials Log
Standardize, control and provide traceability and authorization for employee use of signatures and initials. Includes appropriate forms.
$147.00 Add to Cart
Equipment Cleaning and Use Log
Defines equipment cleaning and use records. Includes appropriate forms.
$147.00 Add to Cart
Record Retention
Defines record retention requirements.
$147.00 Add to Cart
Nonconforming Product
identifies plans to comply with the specified requirements of our quality management system and controls Nonconforming Product, and to set standards for operation.
$147.00 Add to Cart
Corrective and Preventive Action
Defines the steps required to take corrective and preventive action to control out-of-specification results and non-conformances. Includes appropriate forms.
$147.00 Add to Cart
Complaint Handling
Defines the procedure for handling all telephone inquiries and written correspondence received from customers or consumers that may involve product quality. Includes appropriate forms.
$147.00 Add to Cart
Returned Goods
Describes the activities needed to document and address returned products.
$147.00 Add to Cart
Recalls
Defines the procedures to be used to implement a recall, withdrawal or stock recovery.
$147.00 Add to Cart
Pest and Contamination Control
Define the procedures to be used to prevent rodents, insects and other pests from entering the building.
$147.00 Add to Cart
Audits
Define the process for performing internal audits
$147.00 Add to Cart

 

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