Standard Operating Procedures

Improving Standard Operating Procedures:
Overcoming The Complication of Change

Standard Operating Procedures (SOPs) define the essential steps, their sequence, and the precautions necessary to formally repeat a quality performance. In other words, they are a blueprint for risk mitigation. 

Pharmaceutical companies must continually look to improve their SOPs, both for themselves and for their customers. In this process, the cleanroom is the clear priority, as it is the most critical part of any pharmaceutical industrial environment. Procedures must be as pristine as the room itself, with equipment and supplies that work on optimum levels. 

There are definite consequences from not keeping up with SOPs. Here are just a few examples:

• Nature’s Pharmacy and Compounding Center Recalls all Sterile Products Due to Lack of Sterility
• Baxter Initiates Worldwide Recall of Dextrose and Sodium Chloride Due to Particulate Matter in the Solution
• Particulate Matter found in Hospira Inc.’s Lidocaine HCI Injection
• B Braun Medical Issues Recall of Cafeprime and Dextrose Injections after Particulate Matter was found in a Unit
• Lack of Sterility Assurance Causes Abrams Royal Pharmacy to Recall All Sterile Products
• Agila Specialties/Mylan Inc. Recalls Etomidate Injection Due to Black Particulate Contamination
• Ben Venue Laboratories Issues Nationwide Recall Due to Gall Particulate in Acetylcysteine Solution

Searching for More Information on How to Make 
Your SOPs Effective?

Compliance is an opportunity, not a hurdle. Quality management should be a source of renewal for the industry, an inspiration for improvement. Hesitation to update or improve outdated manufacturing processes, methods or equipment will inevitably lead to monetary damages and patient risk. Check out our Executive Briefs below for more information on ways to overcome the dangers of incorrect SOPs.