SOPs: Write it Down!

Jun 25, 2021

The Proof is in the Pudding for Policy & Procedure Manuals

All providers must have a written policy and procedure manual. No matter what type
of inspector or accreditor, they all require that you write your processes down. Not
only is it good business, but it's also required. Luckily, most of the requirements from
the different agencies overlap between agencies.

What are SOPS or a Policy & Procedures Manual?

Written Procedures, SOPs, or policy and procedures manual is a manual describing
the procedures your company follows for the cleaning of equipment, quality control,
calibration procedure, security requirements and other procedures followed by your
company when following the cGMP.

How do they work?

The key with the required written procedures is to be sure to follow what you have
written. If there is ever any deviation from the written procedures, they must be
documented. The person who creates the procedures must sign and date them.
The QCU must review and approve these written procedures and any deviations
from them by signing and dating the procedures.

What should it cover?

Some highlights are: job descriptions, company organizational chart, equipment
cleaning schedules, training programs and security programs. For oxygen fillers
(liquid to liquid, liquid to gas or gas to gas) there are also requirements for handling
the drug product and following cGMP.

I've written them, now what?

It does little good to enact new procedures and controls if they are not read,
understood, and followed by all employees, and readily available. So you'll need to
train your employees on the procedures and ensure that the procedures are actually
being done. Additionally, the procedures should be reviewed periodically by the QCU
to ensure that they are up to date and still fit your company's needs and procedures.

Applied's Policy and Procedure Manuals come as word docs so you can easily
customize them for your company.

With Applied's digital download, you simply insert your name anywhere you see "Company Name" (PRO TIP: Use find and replace to insert your company name throughout the document), and add to or delete
the policies to fit your firm. When you are finished, sign and date the policy and
procedures, and then have your QCU review and do the same. Click here to learn more.

For more information, call 888-327-7301 or email us at

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