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SOPs: Write it Down!

Posted By Carmella Arroyo
June 25, 2021 Category: Policy, Procedures, Manuals, SOPS, CGMP

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 th